Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Official Title

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Keywords

Untreated, Unresectable, or Metastatic Colorectal Cancer, Metastatic Colorectal Cancer (mCRC), Colorectal Neoplasms, Folfox protocol, IFL protocol, Bevacizumab, Pumitamig, FOLFOX, FOLFIRI, CAPOX

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
  • Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
  • Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
  • Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

You CAN'T join if...

  • Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
  • Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
  • Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
  • Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Local Institution - 0330 not yet accepting patients
    Santa Monica California 90404 United States
  • Local Institution - 0317 not yet accepting patients
    San Francisco California 94115 United States
  • Local Institution - 0447 not yet accepting patients
    La Jolla California 92037 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Local Institution - 0293 not yet accepting patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07221357
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 990 study participants
Last Updated