Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03178851
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — BIOLOGICAL
    Atezolizumab, 840 mg intravenously every two weeks (Q2W) on Days 1 and 15 of each 28-day cycle, until loss of clinical benefit
  • Cobimetinib — DRUG
    Cobimetinib, 60 mg orally once daily (QD) on Days 1-21 of each 28-day cycle, until loss of clinical benefit
  • Atezolizumab — BIOLOGICAL
    Atezolizumab, 840 mg intravenously on Day 15 of Cycle 1; thereafter Q2W on Days 1 and 15 of Cycle 2 and all subsequent 28-day cycles, until loss of clinical benefit
  • Atezolizumab — BIOLOGICAL
    Atezolizumab, 1200 mg intravenously every three weeks (Q3W) on Day 1 of each 21-day cycle, until loss of clinical benefit

Study Details

This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT), metastatic, or unresectable locally advanced melanoma who have progressed on prior anti-PD-1 therapy. In addition, this study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab monotherapy in participants with BRAFV600-WT metastatic or unresectable locally advanced melanoma, who have not been previously treated.

Key Dates

Start date
Jun 20, 2017
Status verified
Nov 2021
Primary completion
May 29, 2019
Completion
Sep 21, 2020

Study Design

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

Arms

  • Experimental: Cohort A
    Participants with disease progression on or after treatment with an anti-PD-1 agent will receive cobimetinib and atezolizumab treatment during 28-day cycles.
  • Experimental: Cohort B
    Participants with disease progression on or after treatment with an anti-PD-1 agent will receive cobimetinib prior to initiating atezolizumab treatment during Cycle 1. During subsequent 28-day cycles participants will initiate both atezolizumab and cobimetinib on Day 1 of each cycle. Participants in this cohort will undergo tumor biopsies before and during treatment.
  • Experimental: Cohort C
    Participants with advanced melanoma, who have not received previous treatment, will receive atezolizumab monotherapy during 21-day cycles.

Primary Outcome Measure

Investigator-Assessed Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - BisgroveScottsdaleArizona85258-
University of Colorado Hospital - Anschutz Cancer PavilionAuroraColorado80045-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of MedicineSt LouisMissouri63110-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Baylor University Medical CenterDallasTexas75231-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
HonorHealth Research Institute - Bisgrove· Scottsdale, AZUniversity of Colorado Hospital - Anschutz Cancer Pavilion· Aurora, COKarmanos Cancer Institute· Detroit, MIWashington University School of Medicine· St Louis, MOSarah Cannon Research Institute· Nashville, TNBaylor University Medical Center· Dallas, TX

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