CompletedNCT03414684Updated Sep 9, 2026Results posted

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

A Phase 2 interventional study of Carboplatin and Nivolumab in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 78
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body.

The interventions involved in this study are:

Carboplatin
Nivolumab

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved nivolumab for your specific disease but it has been approved for other uses. The FDA has approved carboplatin as a treatment option for your disease.

The purpose of this research study is to determine how well carboplatin, by itself, or together with nivolumab, works in treating breast cancer that has spread to other parts of the body. Nivolumab is a recently discovered human monoclonal antibody. An antibody is a type of protein that your immune system (the system that defends your body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in your body, such as bacteria and viruses). Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases.

Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cell. Nivolumab has been shown in research studies to prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help your body destroy the cancer cells. You are being asked to participate in this study because triple-negative breast cancer has shown elevated rates of PD-L1 expression.

Nivolumab has been used in other research studies and information from those research studies suggests that nivolumab may help shrink or stabilize your triple negative breast cancer in this study

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,520

Keywords

Breast Cancer

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participants must have histologically or cytologically confirmed invasive breast cancer, with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
Estrogen-receptor and progesterone-receptor expression both ≤ 1% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
Participants must have PD-L1 status available at the time of registration. Standard local testing with any PD-L1 antibody that has been validated in a CLIA-certified environment will be acceptable for including patients on trial.. Primary or metastatic samples may be tested for PD-L1 status.
Participants must have measurable or evaluable disease by RECIST version 1.1.
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline. Previously collected archival tissue will also be obtained on all participants. For participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) the archival tissue alone will be acceptable. Tissue needs to be located and availability confirmed at time of registration (See Section 9 for more details). Participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible. For patients randomized to carboplatin alone who decide to crossover to nivolumab and nab-paclitaxel at time of progression, a mandatory biopsy will be required if tumor is safely accessible prior to initiating crossover treatment; participants must also agree to undergo this biopsy, if applicable.
Prior chemotherapy: Participants must have received 0 prior chemotherapeutic regimens for metastatic breast cancer. Prior platinum in the neo/adjuvant setting is permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease. All toxicities related to prior chemotherapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified.
Prior biologic therapy: Prior poly-ADP ribose polymerase (PARP) inhibitors are not allowed in the metastatic setting. Prior PARP inhibitors in the neo/adjuvant setting are permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease. All toxicities related to prior biologic therapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified.
Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 14 days prior to registration, and all toxicities related to prior radiation therapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified in 3.1.10. Patients may not have had >25% of their bone marrow radiated.
The subject is ≥18 years old.
ECOG performance status ≤1 (Karnofsky >60%, see Appendix A).
Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥ 9.0 g/dl
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or
  ≤5 × institutional ULN for participants with documented liver metastases
- Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 45 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
Supportive care (e.g. transfusion of red blood cells) is allowed to meet eligibility criteria.
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration.
Childbearing potential is defined as: participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception. Contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication. Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment (i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives.)
Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment.
The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

Concurrent administration of any other anti-cancer therapy during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed).
Prior hypersensitivity to platinum chemotherapy or to any of the excipients of platinum or nivolumab therapy.
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including pembrolizumab, ipilimumab, and any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Participants with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those without ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or CT scan) completed during screening. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥7 days prior to registration. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, surgery or a combination as deemed appropriate by the treating physician. Radiation therapy must be completed at least 7 days prior to registration
Major surgery within 2 weeks prior to registration. Patients must have recovered from any effects of any major surgery.
Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator.
Participant has a medical condition that requires chronic systemic steroid therapy (> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.
Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents.
History or evidence of active, non-infectious pneumonitis or interstitial lung disease.
Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibility.
Participant is known to be positive for the human immunodeficiency virus (HIV), HepBsAg, or HCV RNA. HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions of combination antiretroviral therapy with study drugs. In addition, these participants are at increased risk of fatal infections when treated with marrow-suppressive therapy.
The participant has received a live vaccine within 28 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine is allowed.
Women who are pregnant or breastfeeding or adults of reproductive potential not employing an adequate method of contraception.
Childbearing potential is defined as: participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 78 participants (actual)

Study arms

Experimental
Carboplatin + Nivolumab
* Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI
Drug: Carboplatin · Drug: Nivolumab
Active comparator
Carboplatin
* Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI
Drug: Carboplatin

Interventions

DrugCarboplatin
Carboplatin interferes with the development of the genetic material in a cell, which will cause the cancer cells to die.
DrugNivolumab
Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cells
Also known as: Opdivo

What researchers measure

Primary outcomes

Progression-free Survival
Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation
Time frame: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Secondary outcomes

Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Objective Response Rate by Immune-Related Response Criteria (irRC)
Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Overall Survival
Defined as the time from randomization to death due to any cause, or censored at date last known alive
Time frame: Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Clinical Benefit Rate
Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Duration of Response
Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.
Time frame: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Time to Objective Response
Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded
Time frame: Assessed from randomization to the time of first response, up to 3.5 years
Progression-free Survival Among PD-L1-positive Patients
PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients
ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Objective Response Rate by irRC Among PD-L1-positive Patients
ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Overall Survival Among PD-L1-positive Patients
OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Clinical Benefit Rate Among PD-L1-positive Patients
CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Duration of Response Among PD-L1-positive Patients
DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Time to Objective Response Among PD-L1-positive Patients
TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time frame: Assessed from randomization to the time of first response, up to 3.5 years
Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.
Time frame: Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years
Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1., during crossover therapy
Time frame: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC, during second-course therapy
Time frame: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy
Time frame: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation.
Time frame: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years
Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded
Time frame: Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years
Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.
Time frame: Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years
Progression-free Survival Among BRCA-mutant Patients
PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.
Time frame: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients
ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Objective Response Rate by irRC Among BRCA-mutant Patients
ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Overall Survival Among BRCA-mutant Patients
OS defined as the time from randomization to death due to any cause, or censored at date last known alive. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: From date of randomization until the date of death from any cause, assessed up to 3.5 years
Clinical Benefit Rate Among BRCA-mutant Patients
CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Duration of Response Among BRCA-mutant Patients
DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years
Time to Objective Response Among BRCA-mutant Patients
TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time frame: Assessed from randomization to the time of first response, up to 3.5 years

Results

Posted Jan 26, 2023

Participant flow

The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020.

First-course treatment

Participant flow — First-course treatment
Milestone	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Started	39	39
Started treatment	37	38
Completed	0	0
Not completed	39	39
Withdrew: Complete response	0	1
Withdrew: Intercurrent illness	1	0
Withdrew: Progressive disease	31	32
Withdrew: Adverse event	1	2
Withdrew: Physician decision	0	1
Withdrew: Withdrawal by subject	0	1
Withdrew: "patient proceeded with chest wall excision"	1	0
Withdrew: "participant needed palliative radiation, which is not permitted on study"	0	1
Withdrew: Still on treatment	3	0
Withdrew: Never started protocol therapy	2	1

Crossover treatment

Participant flow — Crossover treatment
Milestone	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Started	0	18
Completed	0	0
Not completed	0	18
Withdrew: Progressive disease	0	12
Withdrew: Adverse event	0	3
Withdrew: Physician decision	0	1
Withdrew: Still on treatment	0	2

Outcome measures

PrimaryProgression-free Survival

Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation

Time frame:: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Reported as:: Median · months

Progression-free Survival
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Progression-free Survival	4.2 (2.7 to 11.5)	5.5 (4.4 to 19.2)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.88 · Hazard ratio (hr): 0.95 · 95% CI 0.49 to 1.84Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A

SecondaryObjective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1

Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1	25.0 (11.5 to 43.4)	23.3 (9.9 to 42.3)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Fisher Exact · p = 1 · Odds ratio (or): 1.09 · 95% CI 0.29 to 4.18Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A

SecondaryObjective Response Rate by Immune-Related Response Criteria (irRC)

Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Objective Response Rate by Immune-Related Response Criteria (irRC)
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Objective Response Rate by Immune-Related Response Criteria (irRC)	28.1 (13.7 to 46.7)	—

SecondaryOverall Survival

Defined as the time from randomization to death due to any cause, or censored at date last known alive

Time frame:: Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Reported as:: Median · months

Overall Survival
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Overall Survival	16.8 (10.4 to NA)	11.1 (8.2 to 24.4)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.49 · Hazard ratio (hr): 0.80 · 95% CI 0.43 to 1.50Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondaryClinical Benefit Rate

Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Clinical Benefit Rate
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Clinical Benefit Rate	34.4 (18.6 to 53.2)	33.3 (17.3 to 52.8)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Fisher Exact · p = 1 · Odds ratio (or): 1.05 · 95% CI 0.32 to 3.43Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A

SecondaryDuration of Response

Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.

Time frame:: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Reported as:: Median · months

Duration of Response
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Duration of Response	19.3 (16.8 to NA)	7.7 (2.7 to NA)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.36 · Hazard ratio (hr): 0.53 · 95% CI 0.13 to 2.12Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondaryTime to Objective Response

Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded

Time frame:: Assessed from randomization to the time of first response, up to 3.5 years
Reported as:: Median · months

Time to Objective Response
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Time to Objective Response	4.6 (4.0 to NA)	11.2 (4.7 to NA)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.68 · Hazard ratio (hr): 1.24 · 95% CI 0.43 to 3.43Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondaryProgression-free Survival Among PD-L1-positive Patients

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Reported as:: Median · months

Progression-free Survival Among PD-L1-positive Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Progression-free Survival Among PD-L1-positive Patients	8.3 (2.5 to NA)	4.7 (1.6 to NA)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.27 · Hazard ratio (hr): 0.54 · 95% CI 0.18 to 1.62Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondaryObjective Response Rate by RECIST 1.1 Among PD-L1-positive Patients

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients	23.1 (5.0 to 53.8)	27.3 (6.0 to 61.0)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Fisher Exact · p = 1 · Odds ratio (or): 0.81 · 95% CI 0.08 to 7.78Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A

SecondaryObjective Response Rate by irRC Among PD-L1-positive Patients

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Objective Response Rate by irRC Among PD-L1-positive Patients
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Objective Response Rate by irRC Among PD-L1-positive Patients	30.8 (9.1 to 61.4)	—

SecondaryOverall Survival Among PD-L1-positive Patients

OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Reported as:: Median · months

Overall Survival Among PD-L1-positive Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Overall Survival Among PD-L1-positive Patients	17.6 (4.9 to NA)	10.7 (6.7 to NA)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.61 · Hazard ratio (hr): 0.75 · 95% CI 0.26 to 2.16Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondaryClinical Benefit Rate Among PD-L1-positive Patients

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Clinical Benefit Rate Among PD-L1-positive Patients
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Clinical Benefit Rate Among PD-L1-positive Patients	30.8 (9.1 to 61.4)	36.4 (10.9 to 69.2)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Fisher Exact · p = 1 · Odds ratio (or): 0.79 · 95% CI 0.10 to 5.93Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A

SecondaryDuration of Response Among PD-L1-positive Patients

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Reported as:: Median · months

Duration of Response Among PD-L1-positive Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Duration of Response Among PD-L1-positive Patients	16.8 (NA to NA)	4.9 (2.0 to NA)

SecondaryTime to Objective Response Among PD-L1-positive Patients

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Time frame:: Assessed from randomization to the time of first response, up to 3.5 years
Reported as:: Median · months

Time to Objective Response Among PD-L1-positive Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Time to Objective Response Among PD-L1-positive Patients	NA (3.4 to NA)	NA (3.0 to NA)

Statistical analysis

Arm A: Carboplatin + Nivolumab vs Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion · Log Rank · p = 0.73 · Hazard ratio (hr): 0.75 · 95% CI 0.14 to 3.89Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A

SecondarySecond-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.

Time frame:: Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years
Reported as:: Median · months

Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	4.1 (1.9 to NA)

SecondarySecond-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

Time frame:: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Reported as:: Number · percent of patients

Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	20.0 (2.5 to 55.6)

SecondarySecond-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

Time frame:: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Reported as:: Number · percent of patients

Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	20.0 (2.5 to 55.6)

SecondarySecond-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy

Time frame:: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Reported as:: Number · percent of patients

Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	30.0 (6.7 to 65.2)

SecondarySecond-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation.

Time frame:: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years
Reported as:: Median · months

Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	1.81 (1.81 to NA)

SecondarySecond-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded

Time frame:: Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years
Reported as:: Median · months

Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	NA (3.5 to NA)

SecondarySecond-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab

Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.

Time frame:: Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years
Reported as:: Median · months

Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	—	12.9 (6.4 to NA)

SecondaryProgression-free Survival Among BRCA-mutant Patients

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.

Time frame:: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Reported as:: Median · months

Progression-free Survival Among BRCA-mutant Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Progression-free Survival Among BRCA-mutant Patients	—	4.74 (4.74 to NA)

SecondaryObjective Response Rate by RECIST 1.1 Among BRCA-mutant Patients

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients	—	50.0 (1.3 to 98.7)

SecondaryObjective Response Rate by irRC Among BRCA-mutant Patients

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number

No measurements were reported for this outcome.

SecondaryOverall Survival Among BRCA-mutant Patients

OS defined as the time from randomization to death due to any cause, or censored at date last known alive. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: From date of randomization until the date of death from any cause, assessed up to 3.5 years
Reported as:: Median · months

Overall Survival Among BRCA-mutant Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Overall Survival Among BRCA-mutant Patients	—	24.4 (NA to NA)

SecondaryClinical Benefit Rate Among BRCA-mutant Patients

CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Reported as:: Number · percent of patients

Clinical Benefit Rate Among BRCA-mutant Patients
percent of patients	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Clinical Benefit Rate Among BRCA-mutant Patients	—	50.0 (1.3 to 98.7)

SecondaryDuration of Response Among BRCA-mutant Patients

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years
Reported as:: Median · months

Duration of Response Among BRCA-mutant Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Duration of Response Among BRCA-mutant Patients	—	2.04 (NA to NA)

SecondaryTime to Objective Response Among BRCA-mutant Patients

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Time frame:: Assessed from randomization to the time of first response, up to 3.5 years
Reported as:: Median · months

Time to Objective Response Among BRCA-mutant Patients
months	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Time to Objective Response Among BRCA-mutant Patients	—	3.2 (3.2 to NA)

Adverse events

Collected over Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm A: Carboplatin + Nivolumab	24/37 (64.9%)	10/37 (27%)	37/37 (100%)
Arm B: Carboplatin	17/38 (44.7%)	11/38 (28.9%)	38/38 (100%)
Arm B: Carboplatin -- Crossover	10/18 (55.6%)	6/18 (33.3%)	18/18 (100%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin	Arm B: Carboplatin -- Crossover
Platelet count decreasedInvestigations	3/37	1/38	2/18
Lung infectionInfections and infestations	1/37	1/38	1/18
SepsisInfections and infestations	1/37	0/38	1/18
Blood bilirubin increasedInvestigations	1/37	0/38	1/18
HypoxiaRespiratory, thoracic and mediastinal disorders	2/37	2/38	1/18
PainGeneral disorders	0/37	2/38	1/18
Pleural effusionRespiratory, thoracic and mediastinal disorders	0/37	1/38	1/18
EnterocolitisGastrointestinal disorders	0/37	0/38	1/18
Small intestinal obstructionGastrointestinal disorders	0/37	0/38	1/18
Flu like symptomsGeneral disorders	0/37	0/38	1/18

Most frequent other events

Showing 10 of 102

Most frequent other events
Event	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin	Arm B: Carboplatin -- Crossover
Platelet count decreasedInvestigations	29/37	20/38	5/18
FatigueGeneral disorders	28/37	28/38	11/18
NauseaGastrointestinal disorders	21/37	26/38	7/18
AnemiaBlood and lymphatic system disorders	25/37	20/38	8/18
Neutrophil count decreasedInvestigations	20/37	21/38	7/18
DiarrheaGastrointestinal disorders	11/37	7/38	9/18
ConstipationGastrointestinal disorders	18/37	14/38	4/18
DyspneaRespiratory, thoracic and mediastinal disorders	15/37	17/38	7/18
Peripheral sensory neuropathyNervous system disorders	15/37	11/38	6/18
PainGeneral disorders	10/37	13/38	4/18

Baseline characteristics

78 patients were enrolled and randomized, but only 75 patients started protocol therapy. The primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy.

Age, Continuous
Age, Continuous(years)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Median	59.1 (27.9 to 75.8)	59.1 (25.4 to 75.5)	59.1 (25.4 to 75.8)

Age, Customized
Age, Customized(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Age, years — <40	1	4	5
Age, years — 40-59	19	16	35
Age, years — >=60	17	18	35

Sex: Female, Male
Sex: Female, Male(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Female	37	38	75
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Hispanic or Latino	2	0	2
Not Hispanic or Latino	33	36	69
Unknown or Not Reported	2	2	4

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Asian	1	0	1
Black or African American	2	3	5
Caucasian	30	34	64
More than one race	1	1	2
Other	3	0	3

Germline BRCA Status
Germline BRCA Status(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
gBRCA1 mutation	1	2	3
gBRCA2 mutation	0	1	1
Non-gBRCA1/2 carrier	36	35	71

Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Positive	6	6	12
Negative	11	12	23
Not done	20	20	40

Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142(Participants)	Arm A: Carboplatin + Nivolumab	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion	Total
Positive (>=1% IC)	14	14	28
Negative (<1% IC)	23	24	47

8 further baseline measures are reported on the registry.

Study locations

10 sites

The Stamford Hospital
Stamford, Connecticut 06904, United States
Eastern Maine Medical Center
Bangor, Maine 04401, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02115, United States
St. Elizabeth's Medical Center
Boston, Massachusetts 02135, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts 01757, United States
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts 02190, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire 03053, United States
Ohio State University
Columbus, Ohio 43210, United States
University of Vermont Medical Center
Burlington, Vermont 05401, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 2, 2021

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03414684
Lead sponsor: Dana-Farber Cancer Institute
Collaborators: Bristol-Myers Squibb
Responsible party: Sara Tolaney, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted: Jan 30, 2018
Start date: Jan 30, 2018
Primary completion: Sep 28, 2021
Completion: Aug 5, 2026
Results posted: Jan 26, 2023
Last update: Sep 9, 2026

Study contacts

Sara Tolaney, MD

principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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