A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hoffmann-La Roche
Study ID
NCT03264066
Phase
PHASE2
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Cobimetinib — DRUG
    Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Atezolizumab Cohort 7 — DRUG
    Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.

Study Details

This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab in participants with advanced solid tumors including the following cohorts: squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).

Key Dates

Start date
Nov 23, 2017
Status verified
Apr 2021
Primary completion
Jun 25, 2020
Completion
Jun 25, 2020

Study Design

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

Arms

  • Experimental: Cohort 1 - SCCHN - Treatment Naive
    In participants with recurrent or advanced / metastatic SSCHN who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 2 - UC - Treatment Naive
    In participants with advanced / metastatic UC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 3 - RCC - Treatment Naive
    In participants with metastatic RCC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 milligrams (mg) once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 4 - SCCHN - Previous Treatment Exposure
    In participants with SCCHN whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 5 - UC - Previous Treatment Exposure
    In participants with UC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 6 - RCC - Previous Treatment Exposure
    In participants with RCC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
  • Experimental: Cohort 7 - Biopsy Cohort
    In participants with solid non-melanoma, non- hematologic tumors who previously developed primary or secondary resistance to an anti-PD-1 or anti-PD-L1 agent, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle. The first dose of atezolizumab of 840 mg by IV infusions on Day 15 of Cycle 1. Thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 31 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Kansas City - Menorah Medical CenterKansas CityKansas66209-
Memorial Sloan-Kettering Cancer CenterCommackNew York11725-
Memorial Sloan Kettering - Basking RidgeNew YorkNew York10065-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Washington D.C., DC

By research site
Georgetown University Medical Center· Washington D.C., DCKansas City - Menorah Medical Center· Kansas City, KSMemorial Sloan-Kettering Cancer Center· Commack, NYMemorial Sloan Kettering - Basking Ridge· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute· Nashville, TN

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