Recruiting NCT07221357

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

Phase II / Phase III Interventional Untreated, Unresectable, or Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pumitamig, FOLFOX, FOLFIRI, Bevacizumab.
Who it may be relevant to: Registry conditions: Untreated, Unresectable, or Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

Drug Pumitamig
Specified dose on specified days
Drug FOLFOX
Specified dose on specified days
Drug FOLFIRI
Specified dose on specified days
Drug Bevacizumab
Specified dose on specified days
Drug CAPOX
Specified dose on specified days

Primary outcome measures

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [Time frame: Up to 5 years]
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) [Time frame: Up to 5 years]
Overall Survival (OS) [Time frame: Up to 5 years]

Secondary outcome measures (7)

PFS by RECIST v1.1 per investigator assessment [Time frame: Up to 5 years]
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment [Time frame: Up to 5 years]
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment [Time frame: Up to 5 years]
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment [Time frame: Up to 5 years]
Recommended dose of Pumitamig for Phase 3 [Time frame: Up to 5 years]
OR by RECIST v1.1 per BICR [Time frame: Up to 5 years]
DOR by RECIST v1.1 per BICR [Time frame: Up to 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment