A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02650713
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 of 1200 milligrams (mg) by intravenous (IV) infusion.
  • RO6958688 — DRUG
    RO6958688 is administered by IV infusion In Part IA: RO6958688 is administered weekly (QW) on days 1,8 and 15 of each 21-day cycle. In Part 1b: RO6958688 is administered weekly (QW) or every 3 weeks (Q3W). Cohort A: RO6958688 starting dose will be 100 mg either QW or Q3W. Step Up dose cohorts: RO6958688 starting dose will be 40mg and increase with each administration up to the MTD or 1200 mg whichever is lower.

Study Details

This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.

Key Dates

Start date
Jan 7, 2016
Status verified
Feb 2020
Primary completion
Jan 13, 2020
Completion
Jan 13, 2020

Study Design

Enrollment
228 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Escalation (Part IA): RO6958688 + Atezolizumab
    Participants will receive RO6958688 weekly (QW) at escalating doses starting at 5 mg, in combination with a fixed dose (1200 mg) of atezolizumab every 3 weeks (Q3W). RO6958688 dosage will not exceed the MTD if defined in the BP29541 study.
  • Experimental: Dose/Schedule Finding (Part IB): RO6958688 + Atezolizumab
    Part IB will explore different RO6958688 administration schedules in combination with atezolizumab, consisting of: Cohort A: will compare the QW vs Q3W dosing schedules at a flat dose of RO6958688. Step Up dosing schedules: RO6958688 dose will start at 40 mg and increase with each administration up to the MTD or 1200 mg, whichever occurs first.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to 60 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
UCLA Cancer CenterSanta MonicaCalifornia90404-
Stanford Comprehensive Cancer CenterStanfordCalifornia94305-
University Of ColoradoAuroraColorado80045-
Smilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug PharmacyNew HavenConnecticut06510-
Dana Farber Can InsBostonMassachusetts02215-
Columbia Univ Med CtrNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke Cancer CenterDurhamNorth Carolina27710-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sarah Cannon Cancer CenterGermantownTennessee38138-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Santa Monica, CA

By research site
UCLA Cancer Center· Santa Monica, CAStanford Comprehensive Cancer Center· Stanford, CAUniversity Of Colorado· Aurora, COSmilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug Pharmacy· New Haven, CTDana Farber Can Ins· Boston, MAColumbia Univ Med Ctr· New York, NY

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