Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT01988896
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a fixed dose as specified via IV infusion.
  • Cobimetinib — DRUG
    Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.

Study Details

This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.

Key Dates

Start date
Dec 27, 2013
Status verified
Dec 2019
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019

Study Design

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

Arms

  • Experimental: Dose-Escalation: Cobimetinib, Atezolizumab
    Participants will receive single dose of 800 milligrams (mg) of atezolizumab IV infusion on Day 1, 15 and 29 of Cycle 1 (cycle length=42 days \[14-day run-in period + 28-day concomitant dosing period\]), thereafter with atezolizumab IV dosing every 2 weeks (q2w) in all subsequent treatment cycles (28 days each). Combination with cobimetinib will begin on Cycle 1 Day 15 and will be given at increasing dose levels during Stage 1. During Stage 1, cobimetinib will be administered once daily (QD) orally for 21 consecutive days out of 28 days (21/7 dosing schedule) at a starting dose of 20 mg with escalation of 20 mg until the maximum tolerated dose (MTD; not more than 60 mg) for the two-drug combination.
  • Experimental: Dose-Expansion: Cobimetinib, Atezolizumab
    Participants will receive single dose of 800 mg of atezolizumab IV infusion q2w in all subsequent treatment cycles (28 days each). Participants will receive cobimetinib at the selected recommended RP2D on Days 1-14 of each 28-day cycle during Stage 2.

Primary Outcome Measure

Phase I: Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase ]

Locations (11)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94304-
Rocky Mountain Cancer Center - DenverDenverColorado80220-
Yale University School Of MedicineNew HavenConnecticut06510-
Beth Israel Deaconess Med Ctr; Neurology/MS CenterBostonMassachusetts02215-
Massachusets General Hospital Clinical Trial Network and InstituteBostonMassachusetts02114-
Sloan Kettering Cancer Center; Pediatric Hematology/OncologyNew YorkNew York10065-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
Compass OncologyPortlandOregon97225-
SCRI-Tennessee OncologyNashvilleTennessee37203-
Texas Oncology, P.A.ArlingtonTexas76012-
University of Washington Seattle Cancer Care AllianceSeattleWashington98195-

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical Center· Palo Alto, CARocky Mountain Cancer Center - Denver· Denver, COYale University School Of Medicine· New Haven, CTBeth Israel Deaconess Med Ctr; Neurology/MS Center· Boston, MAMassachusets General Hospital Clinical Trial Network and Institute· Boston, MASloan Kettering Cancer Center; Pediatric Hematology/Oncology· New York, NY

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