A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03555149
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Regorafenib — DRUG
    Regorafenib will be administered orally on Days 1-21 of each 28-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles, with the exception of the Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Idasanutlin, Atezolizumab + Regorafenib and Atezolizumab + Regorafenib + AB928 arms where the Atezolizumab will be administered by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.
  • Imprime PGG — DRUG
    Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion on Day 1 of each 21-day cycle for the Atezolizumab + Imprime PGG + Bevacizumab arm, and on Day 1 and Day 15 of each 28-day cycle for the Atezolizumab + Selicrelumab + Bevacizumab arm.
  • Isatuximab — DRUG
    Isatuximab will be administered on Day 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. Cycles will be 21 days long.
  • Selicrelumab — DRUG
    Selicrelumab will be administered by subcutaneous (SC) injection on Day 1 of cycles 1-4 and every third cycle thereafter. Cycles will be 28 days long.
  • Idasanutlin — DRUG
    Idasanutlin will be administered orally on Days 1-5 of each 28-day cycle.
  • AB928 — DRUG
    AB928 will be administered orally once daily on Days 1-28 of each 28-day cycle.
  • LOAd703 — GENETIC
    LOAd703 will be administered by intratumoral injection on Day 1 of each 21-day cycle.

Study Details

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

Key Dates

Start date
Sep 27, 2018
Status verified
Nov 2023
Primary completion
Sep 26, 2022
Completion
Sep 26, 2022

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Regorafenib (Control)
    Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • Experimental: Atezolizumab + Imprime PGG + Bevacizumab
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + Isatuximab
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + Selicrelumab + Bevacizumab
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + Idasanutlin
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + Regorafenib
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + Regorafenib + AB928
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
  • Experimental: Atezolizumab + LOAd703
    Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.

Primary Outcome Measure

Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: From randomization until disease progression or loss of clinical benefit (up to 4 years) ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Yale UniversityNew HavenConnecticut06511-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAYale University· New Haven, CTDana Farber Cancer Institute· Boston, MAWashington University School of Medicine· St Louis, MOColumbia University Medical Center· New York, NYMemorial Sloan-Kettering Cancer Center· New York, NY

Related Studies