jRCT2031250753RecruitingNot Applicable
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
Not provided0 sites990 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 990
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
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 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, >= 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.
Investigators
Similar Trials
Recruiting
Phase 3
Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Previously Untreated, Unresectable, or Metastatic Colorectal Cancer.2025-523224-45-00Bristol-Myers Squibb Services Unlimited Company334
Completed
Phase 1
A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib2022-502814-99-00Janssen - Cilag International, Janssen - Cilag International72
Completed
Phase 1
A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE AND MULTIPLE ASCENDING DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MES-1022 IN HEALTHY HUMAN SUBJECTS2023-503866-22-00Mesentech Inc.72
Completed
Phase 1
A randomized, Phase 1b, single-center, observer-blind, active-controlled study to evaluate the safety, immunogenicity, and immunological mechanisms of one single administration of TETRALITE influenza vaccine at two dose levels of LiteVax Adjuvant, in healthy participants aged 60 years and older and in healthy participants aged 18 to 50 years.Influenza2023-508230-33-00LiteVax B.V.70
Recruiting
Phase 4
A Phase I double blinded, single-center, randomized, crossover study comparing the PK, PD, safety and tolerability of a single IV dose (1µg/kg) of LB-0702 and Nplate® in healthy volunteers.2024-518285-27-00Laboratorio Reig Jofre S.A.34