A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT02471846
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle with the exception of biopsy cohort A, where atezolizumab administration will start on Cycle 2 Day 1.
  • GDC-0919 — DRUG
    Participants will receive GDC-0919 by mouth (PO) twice daily (BID), specifically every 12 hours. During the dose-escalation stage, the first cohort will receive GDC-0919 at a starting dose of 50 mg PO BID. Dosing will commence on Day -1 for Cycle 1 and follow subsequent 21-day (Days 1 to 21) dosing cycles. The dose will be modified based upon evaluation of DLTs, with single dose escalations not to exceed 2.5-fold of the previous dose. The proposed dosages for evaluation are 50, 100, 200, 400, 600, and 1000 mg PO BID. During the expansion stage, selected solid tumor types will be treated at the MTD or MAD as determined during the dose-escalation stage.

Study Details

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.

Key Dates

Start date
Jul 28, 2015
Status verified
Oct 2019
Primary completion
Oct 2, 2019
Completion
Oct 2, 2019

Study Design

Enrollment
158 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-PD-1/PD-L1 Relapsed Cohort I
    Approximately 20 participants whose most recent anti-cancer therapy consisted of single-agent programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) blockade and achieved best response of confirmed complete or partial response, or stable disease will receive GDC-0919, at the MTD or maximum administered dose (MAD) determined during the dose-escalation stage, in combination with atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.
  • Experimental: Anti-PD-1/PD-L1 Relapsed Cohort II
    Approximately 20 participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade and achieved unconfirmed partial response or stable disease will receive GDC-0919, at the MTD or MAD determined during the dose-escalation stage, in combination with atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.
  • Experimental: Biopsy Cohort A
    Approximately 20 participants with melanoma, HNSCC, gastric, ovarian, Merkel cell, cervical, or endometrial cancer will receive GDC-0919 during Cycle 1, followed by combination treatment with GDC-0919 and atezolizumab from Cycle 2 onwards. Serial biopsies of extrahepatic lesions will be performed. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.
  • Experimental: Biopsy Cohort B
    Approximately 20 participants with melanoma, HNSCC, gastric, ovarian, Merkel cell, cervical, or endometrial cancer will receive atezolizumab during Cycle 1, followed by combination treatment with GDC-0919 and atezolizumab from Cycle 2 onwards. Serial biopsies of extrahepatic lesions will be performed. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.
  • Experimental: Dose-Escalation Cohort(s)
    Approximately 6 to 65 participants will be enrolled and treated at escalating doses of GDC-0919 in combination with fixed-dose atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio. Successive groups of at least 3 participants will be evaluated during a 21-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage. The MTD or MAD, whichever is reached first, will be considered for the expansion stage.
  • Experimental: Expansion Cohorts
    Approximately 160 participants (40 per diagnosis) with NSCLC, RCC, TNBC, and UBC will receive GDC-0919, at the MTD or MAD determined during the dose-escalation stage, in combination with Atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.

Primary Outcome Measure

Percentage of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days) ]

Locations (10)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - BisgroveScottsdaleArizona85258-
The Angeles Clinic and Research Institute, Santa Monica OfficeSanta MonicaCalifornia90025-
University of ColoradoAuroraColorado80045-2517-
Yale Cancer CenterNew HavenConnecticut06520-
H. Lee Moffitt Cancer Center and Research Inst.TampaFlorida33612-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research InstituteNashvilleTennessee37203-

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By research site
HonorHealth Research Institute - Bisgrove· Scottsdale, AZThe Angeles Clinic and Research Institute, Santa Monica Office· Santa Monica, CAUniversity of Colorado· Aurora, COYale Cancer Center· New Haven, CTH. Lee Moffitt Cancer Center and Research Inst.· Tampa, FLJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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