Untreated, Unresectable, or Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic Colorectal Cancer (mCRC)
Brief 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
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGFOLFOX
Specified dose on specified days
DRUGFOLFIRI
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
DRUGCAPOX
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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, ≥ 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Up to 5 years | Phase 2 |
| Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) | Up to 5 years | Phase 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by RECIST v1.1 per investigator assessment | Up to 5 years | Phase 2 |
| Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment | Up to 5 years | Phase 2 |
| Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment | Up to 5 years | Phase 2 |
| Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment | Up to 5 years | Phase 2 |
| Recommended dose of Pumitamig for Phase 3 | Up to 5 years | Phase 2 |
| Overall Survival (OS) | Up to 5 years | Phase 3 |
| OR by RECIST v1.1 per BICR | Up to 5 years | Phase 3 |
| DOR by RECIST v1.1 per BICR | Up to 5 years | Phase 3 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed