A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Genentech, Inc.
Study ID
NCT01656642
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered q3w or q2w.
  • Cobimetinib — DRUG
    Oral repeating dose
  • Vemurafenib — DRUG
    Oral repeating dose, depending on arm/cohort

Study Details

This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled participants may continue treatment until they are no longer experiencing clinical benefit as assessed by the investigator and in alignment with the protocol.

Key Dates

Start date
Aug 13, 2012
Status verified
Jul 2020
Primary completion
Mar 25, 2020
Completion
Mar 25, 2020

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (C1): Ate+Vem - No Run-in
    Participants will receive atezolizumab (Ate) 1200 milligrams (mg) every 3 weeks (q3w) along with vemurafenib (Vem) 720 mg twice daily (BID) for 21 days in each cycle followed by 7 days off treatment (28-day cycle). Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent occurs.
  • Experimental: Cohort 2 (C2): Ate+Vem (56 Day Run-in)
    Run-in period (56 days): participants will receive vemurafenib 960 mg orally BID from Day 1 to 49 and vemurafenib 720 mg orally BID from Day 50 to 56. Combination treatment period: Participants will receive fixed dose of atezolizumab 1200 mg intravenous (IV) q3w in combination with vemurafenib 720 mg orally BID in 21 days cycle.
  • Experimental: Cohort 3 (C3): Ate+Vem (28 Day Run-in)
    Run-in period (28 days): participants will receive vemurafenib 960 mg orally BID for 21 days, then vemurafenib 720 mg orally BID for 7 days. Combination treatment period: Participants will receive fixed dose of atezolizumab 1200 mg IV q3w in combination with vemurafenib 720 mg orally BID in 21 days cycle.
  • Experimental: Cohort 4 (C4): Ate+Vem+Cob (28 Day Run-in)
    Run-in period (28 days): participants will receive vemurafenib 960 mg orally BID for 21 days, then vemurafenib 720 mg orally BID for 7 days in combination with cobimetinib (Cob) 60 mg IV once daily, 21 days on/7 days off schedule (21/7). Combination treatment period: Participants will receive fixed dose of atezolizumab 800 mg IV every 2 weeks (q2w) in combination with vemurafenib 720 mg orally BID and cobimetinib 60 mg orally once daily 21/7 in 28 days cycle.
  • Experimental: ECA: Ate+Vem+Cob (Mandatory Biopsy PD)
    Expansion Cohort A (ECA): Approximately 10 participants who experienced disease progression (PD) after receiving prior checkpoint inhibitor therapy will be enrolled and treated with atezolizumab plus (+) vemurafenib + cobimetinib. Serial biopsy tissue sample collections of accessible lesions will be mandatory for all participants enrolled in this cohort. The doses will be decided based on the results of Cohorts 1-4.
  • Experimental: ECB: Ate+Vem+Cob (Mandatory Biopsy)
    Expansion Cohort B (ECB): Approximately 20 participants will be enrolled and treated with atezolizumab + vemurafenib + cobimetinib. Serial biopsy tissue sample collections of accessible lesions will be mandatory for all participants. The doses will be decided based on the results of Cohorts 1-4.
  • Experimental: ECC: Ate+Vem+Cob (No Mandatory Biopsy)
    Expansion Cohort C (ECC): Approximately 10 participants who experienced disease progression after receiving prior checkpoint inhibitor therapy will be enrolled and treated with atezolizumab + vemurafenib + cobimetinib. Serial biopsy tissue sample collections will be optional for all participants enrolled in this cohort. The doses will be decided based on the results of Cohorts 1-4.

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicities [ Time Frame: 21 days (or 28 days for Cohort 4) following the first administration of atezolizumab ]

Locations (8)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute - W LA OfficeLos AngelesCalifornia90025-
UCLALos AngelesCalifornia90024-
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511AuroraColorado80045-
Florida Cancer Specialists - SarasotaSarasotaFlorida34232-
Dana Farber Can InsBostonMassachusetts02215-
Massachusetts General Hospital.BostonMassachusetts02114-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute - W LA Office· Los Angeles, CAUCLA· Los Angeles, CAUniversity of Colorado Health Science Center; Biomedical Research Bldg. Room 511· Aurora, COFlorida Cancer Specialists - Sarasota· Sarasota, FLDana Farber Can Ins· Boston, MAMassachusetts General Hospital.· Boston, MA

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