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Active, not recruitingNCT03233347Updated Sep 15, 2026Results posted

Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma

A Phase 2 interventional study of Brentuximab Vedotin and Dacarbazine in Ann Arbor Stage I Hodgkin Lymphoma, Ann Arbor Stage IA Hodgkin Lymphoma and Ann Arbor Stage IB Hodgkin Lymphoma, sponsored by Academic and Community Cancer Research United. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
83
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

I. To estimate progression-free survival (PFS) at 3 years in patients with previously untreated stage I or II non-bulky Hodgkin lymphoma (HL) who received doxorubicin, vinblastine, dacarbazine (AVD) plus brentuximab vedotin (BV) induction therapy followed by nivolumab (N)VB consolidation therapy.

SECONDARY OBJECTIVES:

I. To estimate the overall survival (OS) rate at 3 years in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.

II. To estimate the percentage of patients with untreated stage I or II non-bulky HL who are positron emission tomography (PET) positive versus PET negative after 3 cycles of AVD plus BV induction therapy.

III. To estimate PFS and OS at 3 and 5 years separately for patients who are PET negative versus PET positive after 3 cycles of AVD plus BV induction followed by NVB consolidation therapy.

IV. To estimate time to progression (TTP) in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.

V. To estimate the overall response rate and the number of patients who convert to complete response (CMR) after NVB in patients with partial response (PMR) at the end of AVD plus BV induction therapy.

VI. To estimate the duration of response in patients with previously untreated stage I or II non-bulky Hodgkin's lymphoma who received AVD plus BV induction therapy followed by NVB consolidation therapy.

VII. To evaluate the toxicity and tolerability of AVD plus BV induction followed by NVB consolidation therapy as assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v]4).

EXPLORATORY OBJECTIVES:

I. Optional biopsy tissue samples will be collected for future analysis. II. Optional blood sample will be collected for future analysis. III. Cost-benefit analysis of AVD plus BV followed by NVB consolidation, compared to the current standard therapy with adriamycin, bleomycin, vinblastine plus dacarbazine (ABVD) with or without radiation therapy.

OUTLINE:

Patients receive doxorubicin intravenously (IV) over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over >= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 and 8 weeks, every 3 or 6 months for 2 years, and then once a year for 3 years.

02

Conditions studied

  • Ann Arbor Stage I Hodgkin Lymphoma
  • Ann Arbor Stage IA Hodgkin Lymphoma
  • Ann Arbor Stage IB Hodgkin Lymphoma
  • Ann Arbor Stage II Hodgkin Lymphoma
  • Ann Arbor Stage IIA Hodgkin Lymphoma
  • Ann Arbor Stage IIB Hodgkin Lymphoma
  • Classic Hodgkin Lymphoma
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Measurable disease (>= 1.5 cm) as assessed by 2 dimensional measurement by computed tomography (CT)
  • Previously untreated stage I or II non-bulky (defined as a mass measuring \< 10 cm in the longest dimension by CT) classical Hodgkin lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Life expectancy >= 3 months
  • Documented negative serologic testing for human immunodeficiency virus (HIV), hepatitis B (unless serologically positive due to prior vaccination), and hepatitis C =\< 1 year prior to registration
  • White blood cell >= 2,000 /mm\^3 without transfusion support > 7 days prior to registration
  • Hemoglobin >= 8.5 g/dL without transfusion support > 7 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000 cells/mm\^3 without transfusion support > 7 days prior to registration
  • Platelet count >= 75,000/mm\^3 without transfusion support > 7 days prior to registration
  • Alanine and aspartate aminotransferase (ALT/AST) =\< 2.5 x upper limit of normal (ULN) obtained =\< 14 days prior to registration
  • Total serum bilirubin =\< 1.5 x ULN (if documented Gilberts syndrome =\< 3 x ULN) obtained =\< 14 days prior to registration
  • Serum creatinine =\< 1.5 x ULN or measured calculated creatinine clearance >= 40 ml/min for subject with creatinine levels > 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =\< 14 days prior to registration
  • Negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to registration in women of child-bearing potential (WOCBP)
  • Sexually active female of reproductive capability ie, WOCBP, has agreed to use a medically accepted form of contraception from time of registration to completion of study therapy through 24 weeks (6 months) after last dose of NVB or BV; Note: Females of non-child-bearing potential are those who are postmenopausal for > 1 year or who have had a bilateral tubal ligation or hysterectomy
  • Male subjects agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

    • Note: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up

Exclusion criteria

Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Prior therapies including involved field radiation therapy
  • Bulky disease (defined as a nodal mass measuring >= 10 cm by CT)
  • Known central nervous system (CNS) involvement
  • Moderate or severe hepatic insufficiency Child-Pugh score > 6
  • Severe renal impairment (i.e. creatinine clearance \< 40 mL/min)
  • Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 45%, symptomatic coronary artery disease or symptomatic arrhythmias
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =\< 7 days prior to registration
  • Known history of active TB (Bacillus tuberculosis)
  • Requires therapy with agents that have a predisposition for hepatoxicity
  • Hypersensitivity to NVB or any of its excipients or to any component of AVD + BV therapy
  • Requires immunosuppressive doses of corticosteroid therapy (> 10 mg/day prednisone equivalents) for >= 2 weeks prior to registration
  • Active, known, or suspected autoimmune disease that requires systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Active infection requiring systemic IV antibiotic therapy
  • History of Steven's Johnson's syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Received a live vaccine =\< 30 days prior to registration; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed; routine vaccinations, including seasonal influenza, must be given >= 2 weeks prior to registration
  • History of allergies and adverse drug reaction to study drug components
  • History of another primary malignancy that has not been in remission for at least 3 years; (Note: The following are exempt for the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • History of progressive promyelocytic leukemia (PML), known history of pancreatitis, active grade 3 or higher viral, bacterial or fungal infection =\< 2 weeks prior to registration and documented history of cerebrovascular event (stroke or transient ischemic attack [TIA]) =\< 6 months prior to registration
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    Treatment (combination chemotherapy, nivolumab)

    Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over \>= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Brentuximab Vedotin · Drug: Dacarbazine · Drug: Doxorubicin · Other: Laboratory Biomarker Analysis · Biological: Nivolumab · Drug: Vinblastine

Interventions

  • DrugBrentuximab Vedotin

    Given IV

    Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35

  • DrugDacarbazine

    Given IV

    Also known as: 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine, Dacarbazina, Dacarbazina Almirall, Dacarbazine - DTIC, Dacatic, Dakarbazin, Deticene, Detimedac, DIC, Dimethyl (triazeno) imidazolecarboxamide, Dimethyl Triazeno Imidazol Carboxamide, Dimethyl Triazeno Imidazole Carboxamide, dimethyl-triazeno-imidazole carboxamide, Dimethyl-triazeno-imidazole-carboximide, DTIC, DTIC-Dome, Fauldetic, Imidazole Carboxamide, Imidazole Carboxamide Dimethyltriazeno, WR-139007

  • DrugDoxorubicin

    Given IV

    Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalNivolumab

    Given IV

    Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

  • DrugVinblastine

    Given IV

    Also known as: Vincaleucoblastine, VLB

05

What researchers measure

Primary outcomes

  1. Progression Free Survival

    The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. 3 year PFS with 95% CI will be reported.

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival

    Overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival time will be estimated using the method of Kaplan-Meier. The rate of overall survival at 3 years and 5 years will be estimated.

    Time frame: Time from registration to death due to any cause, assessed at 3 and 5 years

  2. The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative

    The proportion of patients who are PET negative after 3 cycles of treatment will be estimated by the number of patients who are PET negative divided by the total number of evaluable patients. PET will be considered negative if the patient is given a Deauville score of ≤ 3.

    Time frame: 3 courses (84 days)

  3. Proportion of Patients Who Are Positron Emission Tomography (PET) Positive

    The proportion of patients who are PET positive after 3 cycles of treatment will be estimated by the number of patients who are PET positive divided by the total number of evaluable patients.

    Time frame: 3 courses (84 days)

  4. Progression Free Survival

    Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

    Time frame: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 3 years

  5. Progression Free Survival

    Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

    Time frame: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 5 years

  6. Overall Response Rate (ORR)

    The ORR will be estimated by the number of patients with an complete response (CR)/complete metabolic response/partial response (PR)/partial metabolic response or better divided by the total number of evaluable patients. The ORR may be analysed when all patients are off treatment.

    Time frame: 5 years

  7. Time to Progression

    Time to progression is defined as the time from registration to the earliest date of documentation of disease progression (PD or PMD).\> Patients who are progression-free will be censored on the date of their last disease assessment. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Time frame: 5 years

  8. The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)

    The proportion of patients who convert from partial response (PMR) at the end of AVD plus BV induction therapy to complete response\> (CMR) after NVB will be estimated by the number of patients who convert divided by the total number of evaluable patients who receive at least one dose of NVB induction therapy. Exact binomial 95% confidence intervals for the true conversion rate will be calculated.

    Time frame: 5 years

  9. Median Duration of Response

    Duration of response is defined for all evaluable patients who have achieved a PR or CR as the date at which the patient's objective status is first noted to be a response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

    Time frame: 5 years

  10. Number of Patients Experiencing Grade 3+ Adverse Events

    Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients experiencing at least one grade 3 or greater AE regardless of attribution will be reported.

    Time frame: 5 years

06

Results

Posted Sep 15, 2026

Participant flow

AVD + Brentuximab Vedotin (BV)
Participant flow — AVD + Brentuximab Vedotin (BV)
MilestoneTreatment (Combination Chemotherapy, Nivolumab)
Started80
Completed77
Not completed3
Withdrew: Withdrawal by subject1
Withdrew: Adverse event2
Nivolumab Consolidation
Participant flow — Nivolumab Consolidation
MilestoneTreatment (Combination Chemotherapy, Nivolumab)
Started77
Completed67
Not completed10
Withdrew: Adverse event6
Withdrew: Withdrawal by subject2
Withdrew: Other2

Outcome measures

PrimaryProgression Free Survival

The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. 3 year PFS with 95% CI will be reported.

Time frame:
3 years
Reported as:
Number · percentage of patients alive and PF
Progression Free Survival
percentage of patients alive and PFTreatment (Combination Chemotherapy, Nivolumab)
Progression Free Survival96.48 (91.79 to 100)
SecondaryOverall Survival

Overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival time will be estimated using the method of Kaplan-Meier. The rate of overall survival at 3 years and 5 years will be estimated.

Time frame:
Time from registration to death due to any cause, assessed at 3 and 5 years
Reported as:
Number · percentage of participants alive
Overall Survival
percentage of participants aliveTreatment (Combination Chemotherapy, Nivolumab)
3 years100 (100 to 100)
5 years100 (100 to 100)
SecondaryThe Proportion of Patients Who Are Positron Emission Tomography (PET) Negative

The proportion of patients who are PET negative after 3 cycles of treatment will be estimated by the number of patients who are PET negative divided by the total number of evaluable patients. PET will be considered negative if the patient is given a Deauville score of ≤ 3.

Time frame:
3 courses (84 days)
Reported as:
Count of participants · Participants
The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative
ParticipantsTreatment (Combination Chemotherapy, Nivolumab)
The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative73
SecondaryProportion of Patients Who Are Positron Emission Tomography (PET) Positive

The proportion of patients who are PET positive after 3 cycles of treatment will be estimated by the number of patients who are PET positive divided by the total number of evaluable patients.

Time frame:
3 courses (84 days)
Reported as:
Count of participants · Participants
Proportion of Patients Who Are Positron Emission Tomography (PET) Positive
ParticipantsTreatment (Combination Chemotherapy, Nivolumab)
Proportion of Patients Who Are Positron Emission Tomography (PET) Positive4
SecondaryProgression Free Survival

Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

Time frame:
From registration, where progression is by CT-based or PET-CT based criteria, assessed at 3 years
Reported as:
Number · percentage of patients alive and PF
Progression Free Survival
percentage of patients alive and PFTreatment (Combination Chemotherapy, Nivolumab) - PET NegativeTreatment (Combination Chemotherapy, Nivolumab) - PET Positive
Progression Free Survival96.25 (91.27 to 100)100 (100 to 100)
SecondaryProgression Free Survival

Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

Time frame:
From registration, where progression is by CT-based or PET-CT based criteria, assessed at 5 years
Reported as:
Number · percentage of patients alive and PF
Progression Free Survival
percentage of patients alive and PFTreatment (Combination Chemotherapy, Nivolumab) - PET NegativeTreatment (Combination Chemotherapy, Nivolumab) - PET Positive
Progression Free Survival96.25 (91.27 to 100)—
SecondaryOverall Response Rate (ORR)

The ORR will be estimated by the number of patients with an complete response (CR)/complete metabolic response/partial response (PR)/partial metabolic response or better divided by the total number of evaluable patients. The ORR may be analysed when all patients are off treatment.

Time frame:
5 years
Reported as:
Count of participants · Participants
Overall Response Rate (ORR)
ParticipantsTreatment (Combination Chemotherapy, Nivolumab)
Overall Response Rate (ORR)79
SecondaryTime to Progression

Time to progression is defined as the time from registration to the earliest date of documentation of disease progression (PD or PMD).\> Patients who are progression-free will be censored on the date of their last disease assessment. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

Time frame:
5 years
Reported as:
Median · months
Time to Progression
monthsTreatment (Combination Chemotherapy, Nivolumab)
Time to ProgressionNA (NA to NA)
SecondaryThe Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)

The proportion of patients who convert from partial response (PMR) at the end of AVD plus BV induction therapy to complete response\> (CMR) after NVB will be estimated by the number of patients who convert divided by the total number of evaluable patients who receive at least one dose of NVB induction therapy. Exact binomial 95% confidence intervals for the true conversion rate will be calculated.

Time frame:
5 years
Reported as:
Count of participants · Participants
The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)
ParticipantsTreatment (Combination Chemotherapy, Nivolumab)
The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)3
SecondaryMedian Duration of Response

Duration of response is defined for all evaluable patients who have achieved a PR or CR as the date at which the patient's objective status is first noted to be a response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

Time frame:
5 years
Reported as:
Median · months
Median Duration of Response
monthsTreatment (Combination Chemotherapy, Nivolumab)
Median Duration of ResponseNA (NA to NA)
SecondaryNumber of Patients Experiencing Grade 3+ Adverse Events

Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients experiencing at least one grade 3 or greater AE regardless of attribution will be reported.

Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Patients Experiencing Grade 3+ Adverse Events
ParticipantsTreatment (Combination Chemotherapy, Nivolumab)
Number of Patients Experiencing Grade 3+ Adverse Events49

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Combination Chemotherapy, Nivolumab)0/80 (0%)33/80 (41.3%)76/80 (95%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventTreatment (Combination Chemotherapy, Nivolumab)
Febrile neutropeniaBlood and lymphatic system disorders5/80
Abdominal painGastrointestinal disorders4/80
NauseaGastrointestinal disorders4/80
ConstipationGastrointestinal disorders3/80
VomitingGastrointestinal disorders3/80
FeverGeneral disorders and administration site conditions3/80
Lung infectionInfections and infestations3/80
Peripheral motor neuropathyNervous system disorders3/80
DiarrheaGastrointestinal disorders2/80
IleusGastrointestinal disorders2/80
Most frequent other events
Showing 10 of 123
Most frequent other events
EventTreatment (Combination Chemotherapy, Nivolumab)
FatigueGeneral disorders and administration site conditions34/80
Peripheral sensory neuropathyNervous system disorders34/80
NauseaGastrointestinal disorders33/80
Neutrophil count decreasedInvestigations31/80
Alanine aminotransferase increasedInvestigations25/80
DyspneaRespiratory, thoracic and mediastinal disorders17/80
ConstipationGastrointestinal disorders16/80
DiarrheaGastrointestinal disorders16/80
AlopeciaSkin and subcutaneous tissue disorders16/80
Aspartate aminotransferase increasedInvestigations14/80

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Combination Chemotherapy, Nivolumab)
Mean34.8 ± 11.12
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Combination Chemotherapy, Nivolumab)
Female40
Male40
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Combination Chemotherapy, Nivolumab)
Hispanic or Latino15
Not Hispanic or Latino63
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Combination Chemotherapy, Nivolumab)
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American4
White66
More than one race0
Unknown or Not Reported6
Region of Enrollment
Region of Enrollment(participants)Treatment (Combination Chemotherapy, Nivolumab)
United States80
07

Study locations

9 sites
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • University of Pennsylvania/Abramson Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
  • University of Washington Medical Center - Montlake
    Seattle, Washington 98195, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 15, 2021

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

09

Registry details

Key details

Study ID
NCT03233347
Lead sponsor
Academic and Community Cancer Research United
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 28, 2017
Start date
Oct 13, 2017
Primary completion
Jul 1, 2025
Completion
Jul 8, 2027 (estimated)
Results posted
Sep 15, 2026
Last update
Sep 15, 2026

Study contacts

Steven I Park
principal investigator · Academic and Community Cancer Research United

Oversight

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