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RecruitingPhase 2 / Phase 3

A Study 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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares pumitamig plus chemotherapy with bevacizumab plus chemotherapy to see how safe they are and how well they work. It is for people with untreated colon or rectal cancer that has come back or spread and cannot be cured with surgery.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have colon or rectal adenocarcinoma, a cancer that starts in gland cells, confirmed by a tissue test.
  • Your cancer must be untreated, have come back or spread, and not be curable with surgery.
  • Past test results must not show dMMR or MSI-H, signs of certain problems with how cancer cells repair their DNA.
  • Local testing must not show a BRAF V600E gene change.
  • Your cancer must be measurable using the study’s rules.

Who can't join

  • You cannot have known, untreated cancer spread to the brain or its coverings, or cancer spread that presses on the spinal cord.
  • You cannot have had another cancer active in the past 2 years, unless it appears cured by local treatment and has a low risk of coming back.
  • You cannot have serious heart or blood vessel disease. This includes a heart attack, unstable chest pain, an artery blood clot, or a stroke in the 6 months before study group assignment.
  • You cannot have blood pressure of 160 or higher for the top number, or 100 or higher for the bottom number, despite the best medical treatment.
  • You cannot have been born with long QT syndrome, a condition that affects the heart’s electrical rhythm.
  • You cannot have had chemotherapy or certain immune treatments that target T cells, which are immune cells, or their control signals.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * 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. Exclusion Criteria * 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.

Study sites (46)

AR

AZ

CA

FL

GA

IA

IL

IN

MA

MD

MI

MN

MO

NC

ND

NE

NY

OH

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Shafia Rahman, Site 0339 · Study contact · 614-293-3890More trials in Columbus

PA

SD

TN

TX

UT

VA

WA