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CompletedNCT04177108Updated Mar 27, 2024Results posted

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase 3 interventional study of Atezolizumab and Ipatasertib in Triple-Negative Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 182 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

02

Conditions studied

  • Triple-Negative Breast Cancer

Keywords

  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Breast Diseases
  • Skin Diseases
  • Paclitaxel
  • Atezolizumab
  • Ipatasertib
  • Antibodies, Monoclonal
  • Antineoplastic Agents, Phytogenic
  • Antineoplastic Agents
  • Tubulin Modulators
  • Antimitotic Agents
  • Mitosis Modulators
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 242 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  1. Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
  2. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
  3. Life expectancy of at least 6 months.
  4. Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
  7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
  8. Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
  9. Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.

Exclusion criteria

Exclusion Criteria:

  1. Inability to comply with study and follow-up procedures.
  2. History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
  3. Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
  4. Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
  5. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
  6. Current treatment with anti-viral therapy for hepatitis B virus (HBV).
  7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
  8. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
  9. New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (\<) 50 percent (%), or active ventricular arrhythmia requiring medication.
  10. Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
  11. Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (>) 480 milliseconds (ms).
  12. Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
  13. History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
  14. Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
  15. Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
  16. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications.
  17. History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
  18. Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases.
  19. Known germline breast cancer gene (BRCA)1/2 deleterious mutation, unless the participant is not an appropriate candidate for a poly adenosine diphosphate ribose polymerase (PARP)-inhibitor.
  20. Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
  21. Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
  22. Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
  23. Uncontrolled pleural effusion, pericardial effusion or ascites.
  24. Uncontrolled tumor-related pain.
  25. Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
  26. Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
  27. Grade greater than or equal to (≥) 2 peripheral neuropathy.
  28. History of Type I or Type II diabetes mellitus requiring insulin.
  29. Grade ≥ 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  30. History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
  31. Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
  32. Treatment with strong Cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
  33. Prior treatment with an Protein kinase B (Akt) inhibitor.
  34. Active or history of autoimmune disease or immune deficiency.
  35. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  36. Prior allogeneic stem cell or solid organ transplantation.
  37. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the final dose of atezolizumab.
  38. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  39. Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
  40. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
  41. Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel

    TNBC participants with programmed death-ligand 1 (PD-L1) non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

    Drug: Atezolizumab · Drug: Ipatasertib · Drug: Paclitaxel

  • Experimental
    Cohort 1 Arm B: Ipatasertib + Placebo + Paclitaxel

    TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

    Drug: Ipatasertib · Drug: Paclitaxel · Drug: Placebo for Atezolizumab

  • Experimental
    Cohort 1 Arm C: Placebo + Placebo + Paclitaxel

    TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

    Drug: Paclitaxel · Drug: Placebo for Atezolizumab · Drug: Placebo for Ipatasertib

  • Experimental
    Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel

    TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

    Drug: Atezolizumab · Drug: Ipatasertib · Drug: Paclitaxel

  • Experimental
    Cohort 2 Arm B: Placebo+ Atezolizumab + Paclitaxel

    TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

    Drug: Atezolizumab · Drug: Paclitaxel · Drug: Placebo for Ipatasertib

Interventions

  • DrugAtezolizumab

    Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions.

  • DrugIpatasertib

    Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions.

  • DrugPaclitaxel

    Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions.

  • DrugPlacebo for Atezolizumab

    Placebo was administered as per the dosage regimen mentioned in arm descriptions.

  • DrugPlacebo for Ipatasertib

    Placebo was administered as per the dosage regimen mentioned in arm descriptions.

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.

    Time frame: From Randomization to disease progression, study completion, or death (up to 39 months)

  2. Overall Survival (OS)

    OS was defined as the time from randomization to the time of death from any cause on study.

    Time frame: From randomization up to study completion or death (Up to 39 months)

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Time frame: Up to 39 months

07

Results

Posted Mar 27, 2024

Participant flow

Participants took part in the study at 215 investigative centers from 25 November 2019 to 28 February 2023.

Participant flow — Overall Study
MilestoneCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Started4343415857
Completed00000
Not completed4343415857
Withdrew: Withdrawal by subject4891113
Withdrew: Physician decision2315182923
Withdrew: Reason not specified01002
Withdrew: Lost to follow-up00111
Withdrew: Death1619131718

Outcome measures

PrimaryProgression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.

Time frame:
From Randomization to disease progression, study completion, or death (up to 39 months)
Reported as:
Median · months
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
monthsCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.17.1 (5.1 to 9.3)5.6 (3.7 to 8.2)3.7 (3.6 to 5.4)5.6 (5.4 to 9.2)5.7 (4.0 to 9.1)
Statistical analysis
  • Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel · Log Rank · p = 0.0098 · Hazard ratio (hr): 0.49 · 95% CI 0.28 to 0.85
  • Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel · Log Rank · p = 0.2396 · Hazard ratio (hr): 0.72 · 95% CI 0.42 to 1.25
  • Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel · Log Rank · p = 0.9809 · Hazard ratio (hr): 0.99 · 95% CI 0.63 to 1.58
PrimaryOverall Survival (OS)

OS was defined as the time from randomization to the time of death from any cause on study.

Time frame:
From randomization up to study completion or death (Up to 39 months)
Reported as:
Median · months
Overall Survival (OS)
monthsCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Overall Survival (OS)15.7 (12.5 to NA)15.3 (15.3 to NA)16.6 (9.6 to NA)NA (14.1 to NA)17.2 (13.4 to NA)
Statistical analysis
  • Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel · Log Rank · p = 0.6805 · Hazard ratio (hr): 1.17 · 95% CI 0.55 to 2.51
  • Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel vs Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel · Log Rank · p = 0.6314 · Hazard ratio (hr): 1.21 · 95% CI 0.55 to 2.64
  • Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel vs Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel · Log Rank · p = 0.9164 · Hazard ratio (hr): 1.04 · 95% CI 0.52 to 2.06
SecondaryNumber of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame:
Up to 39 months
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Number of Participants With Adverse Events (AEs)4243405856

Adverse events

Collected over Up to 39 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel16/43 (37.2%)14/43 (32.6%)42/43 (97.7%)
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel19/43 (44.2%)7/43 (16.3%)42/43 (97.7%)
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel13/41 (31.7%)7/41 (17.1%)40/41 (97.6%)
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe18/58 (31%)16/58 (27.6%)56/58 (96.6%)
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel18/57 (31.6%)9/57 (15.8%)55/57 (96.5%)
Most frequent serious events
Showing 10 of 58
Most frequent serious events
EventCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxeCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
RashSkin and subcutaneous tissue disorders3/431/430/411/580/57
COVID-19Infections and infestations0/431/432/410/580/57
DiarrhoeaGastrointestinal disorders2/431/430/411/580/57
CellulitisInfections and infestations2/430/430/410/580/57
Septic shockInfections and infestations2/430/430/410/580/57
NeutropeniaBlood and lymphatic system disorders0/430/430/412/580/57
Alanine aminotransferase increasedInvestigations1/430/430/412/580/57
Aspartate aminotransferase increasedInvestigations1/430/430/412/580/57
Clostridium colitisInfections and infestations0/430/431/410/580/57
Diarrhoea infectiousInfections and infestations0/430/431/410/580/57
Most frequent other events
Showing 10 of 90
Most frequent other events
EventCohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxeCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
DiarrhoeaGastrointestinal disorders32/4330/4315/4137/5816/57
ConstipationGastrointestinal disorders7/4312/4326/4116/5824/57
AlopeciaSkin and subcutaneous tissue disorders10/4313/4319/4118/5825/57
NauseaGastrointestinal disorders17/4314/439/4122/5813/57
AnaemiaBlood and lymphatic system disorders15/437/436/4122/5812/57
NeutropeniaBlood and lymphatic system disorders15/435/438/4111/589/57
Neuropathy peripheralNervous system disorders15/438/4310/418/588/57
RashSkin and subcutaneous tissue disorders10/4310/437/4119/5817/57
Alanine aminotransferase increasedInvestigations11/4311/4312/4112/5811/57
Decreased appetiteMetabolism and nutrition disorders6/436/436/4116/587/57

Baseline characteristics

Intent-to-treat (ITT) population included all participants randomized in this study.

Age, Continuous
Age, Continuous(years)Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + PaclitaxelTotal
Mean55.5 ± 11.750.8 ± 11.653.5 ± 10.753.7 ± 12.151.1 ± 11.752.9 ± 11.7
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + PaclitaxelTotal
Female4343415857242
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + PaclitaxelTotal
Hispanic or Latino896151452
Not Hispanic or Latino3232354143183
Unknown or Not Reported320207
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + PaclitaxelCohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + PaclitaxelCohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelCohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + PaclitaxelTotal
American Indian or Alaska Native5315620
Asian1079191661
Native Hawaiian or Other Pacific Islander000000
Black or African American220228
White2629292932145
More than one race001012
Unknown or Not Reported021306
08

Study locations

182 sites
  • USA Mitchell Cancer Institute
    Mobile, Alabama 36688, United States
  • Highlands Oncology Group
    Springdale, Arkansas 72762, United States
  • UCLA
    Los Angeles, California 90095, United States
  • Kaiser Permanente-SCPMG; Oncology Research
    San Diego, California 92108, United States
  • Stanford Cancer Center
    Stanford, California 94305-5820, United States
  • Kaiser Permanente - Franklin
    Denver, Colorado 80205, United States
  • Stamford Hospital; BCC, MOHR
    Stamford, Connecticut 06904, United States
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Memorial Healthcare System - Memorial Regional Hospital
    Hollywood, Florida 33021, United States
  • Memorial Cancer Institute at Memorial West
    Pembroke Pines, Florida 33028, United States
  • Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME
    Savannah, Georgia 31405, United States
  • Rush University
    Chicago, Illinois 60612, United States
  • Ochsner Clinic Foundation
    Baton Rouge, Louisiana 70809, United States
  • Ochsner Health System
    New Orleans, Louisiana 70121, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Mercy Medical Center
    Baltimore, Maryland 21202, United States
  • Medstar Franklin Square Medical Center
    Baltimore, Maryland 21237, United States
  • St. Joseph Mercy Hospital; Cancer Care Center.
    Ann Arbor, Michigan 48106, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Jackson Oncology Associates, PLLC
    Jackson, Mississippi 39202, United States
  • CHI Health Saint Francis; Oncology
    Grand Island, Nebraska 68803, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Hackensack Univ Med Ctr
    Hackensack, New Jersey 07601, United States
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Kaiser Permanente - Portland
    Portland, Oregon 97227, United States
  • Oregon Health and Science University
    Portland, Oregon 97229, United States
  • Charleston Oncology, P .A
    Charleston, South Carolina 29414, United States
  • Greenville Health System; Cancer Center
    Greenville, South Carolina 29605-4292, United States
  • The West Clinic; West Cancer Center
    Germantown, Tennessee 38138, United States
  • Vanderbilt Univ Medical Ctr
    Nashville, Tennessee 37203, United States
  • Fundación CENIT para la Investigación en Neurociencias
    Buenos Aires, C1125ABD, Argentina
  • Inst. Angel Roffo; Haematology
    Buenos Aires, C1417DTB, Argentina
  • Hospital Britanico
    Ciudad Autonoma Bs As, C1280AEB, Argentina
  • Instituto Medico Rio Cuarto
    Cordoba, X5800AEU, Argentina
  • Centro Oncologico Riojano Integral (CORI)
    La Rioja, F5300COE, Argentina
  • Fundacion Scherbovsky
    Mendoza, M5500AYB, Argentina
  • Macquarie University Hospital
    Macquarie Park, New South Wales 2109, Australia
  • Mid North Coast Cancer Institute
    Port Macquarie, New South Wales 2444, Australia
  • Royal North Shore Hospital; Department of Medical Oncology
    St Leonards, New South Wales 2065, Australia
  • Calvary Mater Newcastle; Medical Oncology
    Waratah, New South Wales 2298, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
  • Adelaide Cancer Centre
    Kurralta Park, South Australia 5037, Australia
  • Monash Health Monash Medical Centre
    Clayton, Victoria 3168, Australia
  • Peter MacCallum Cancer Centre; Medical Oncology
    Melbourne, Victoria 3000, Australia
  • Sunshine Hospital; Oncology Research
    St Albans, Victoria, Australia
  • St John of God Hospital; Bendat Cancer Centre
    Subiaco, Western Australia 6008, Australia
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
    Innsbruck, 6020, Austria
  • Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
    Linz, 4010, Austria
  • Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
    Salzburg, 5020, Austria
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
    Wien, 1090, Austria
  • AZ Maria Middelares
    Gent, 9000, Belgium
  • Jessa Zkh (Campus Virga Jesse)
    Hasselt, 3500, Belgium
  • Hospital Sao Rafael - HSR
    Salvador, BA 41253-190, Brazil
  • Hospital das Clinicas - UFRGS
    Porto Alegre, RS 90035-903, Brazil
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
    Sao Paulo, SP 01317-001, Brazil
  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
    Sao Paulo, SP 04014-002, Brazil
  • MHAT Nadezhda
    Sofia, 1330, Bulgaria
  • Cross Cancer Institute ; Dept of Medical Oncology
    Edmonton, Alberta T6G 1Z2, Canada
  • Fraser Valley Centre British Columbia Cancer Agency
    Surrey, British Columbia V3V 1Z2, Canada
  • Cancer Care Manitoba
    Winnipeg, Manitoba R3E 0V9, Canada
  • Royal Victoria Hospital
    Barrie, Ontario L4M 6M2, Canada
  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario K2H 6C2, Canada
  • McGill University; Glen Site; Oncology
    Montreal, Quebec H4A 3J1, Canada
  • Jewish General Hospital; Research Unit
    Montréal, Quebec H3T 1E2, Canada
  • Hopital du Saint Sacrement
    Quebec City, Quebec G1S 4L8, Canada
  • Clinica del Country
    Bogota, 11001, Colombia
  • Oncólogos de Occidente
    Pereira, 600004, Colombia
  • Clinica CIMCA
    San José, 10103, Costa Rica
  • Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
    Brno, 656 53, Czechia
  • Fakultni nemocnice Olomouc; Onkologicka klinika
    Olomouc, 779 00, Czechia
  • Herlev Hospital; Afdeling for Kræftbehandling
    Herlev, 2730, Denmark
  • Odense Universitetshospital, Onkologisk Afdeling R
    Odense C, 5000, Denmark
  • Docrates Cance Center
    Helsinki, 00180, Finland
  • KYS Sadesairaala; Syopatautien poliklinikka
    Kuopio, 70210, Finland
  • VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
    Vaasa, 65130, Finland
  • Centre Eugene Marquis; Service d'oncologie
    Rennes, 35042, France
  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
    Kifisia, 145 64, Greece
  • Euromedical General Clinic of Thessaloniki; Oncology Department
    Thessaloniki, 546 45, Greece
  • Queen Mary Hospital; Dept of Medicine
    Hong Kong, Hong Kong
  • Tuen Mun Hospital; Clinical Onc
    Hong Kong, Hong Kong
  • Prince of Wales Hospital; Department of Clinical Onocology
    Shatin, Hong Kong
  • Sahyadri Super Specialty Hospital Hadapsar
    Pune, Maharashtra 411028, India
  • Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    Napoli, Campania 80131, Italy
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    Meldola, Emilia-Romagna 47014, Italy
  • ASU FC S. M. DELLA MISERICORDIA; Oncologia
    Udine, Friuli-Venezia Giulia 33100, Italy
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
    Brescia, Lombardia 25123, Italy
  • ASST DI LECCO; Oncologia Medica
    Lecco, Lombardia 23900, Italy
  • IRCCS Istituto Clinico Humanitas; Oncologia
    Rozzano (MI), Lombardia 20089, Italy
  • Ospedale Civile; Unita Operativa Di Oncologia Medica
    Livorno, Toscana 57100, Italy
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
    Padova, Veneto 35128, Italy
  • Aichi Cancer Center Hospital
    Aichi, 464-8681, Japan
  • Fukushima Medical University Hospital
    Fukushima, 960-1295, Japan
  • Gunma Prefectural Cancer Center
    Gunma, 373-8550, Japan
  • Hiroshima University Hospital
    Hiroshima, 734-8551, Japan
  • Kanagawa Cancer Center
    Kanagawa, 241-8515, Japan
  • Kumamoto Shinto General Hospital
    Kumamoto, 862-8655, Japan
  • Okayama University Hospital
    Okayama, 700-8558, Japan
  • Osaka International Cancer Institute
    Osaka, 541-8567, Japan

Showing the first 100 of 182 sites across 37 countries.

09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 25, 2022

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

Individual participant data

Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04177108
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 26, 2019
Start date
Nov 25, 2019
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Results posted
Mar 27, 2024
Last update
Mar 27, 2024

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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