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
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Enrollment
- 346
- Locations
- 102
- Primary Endpoint
- Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
Overview
Brief Summary
Phase 2: The main objective will be to compare the tumor response to the drug of participants on study drug vs standard of care. Phase 3: The main objective is to compare the tumor growth of participants on study drug vs standard of care.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must be at least 18 years of age.
- •Have colorectal cancer that has come back or spread and cannot be cured with surgery.
- •Have not had cancer treatment before.
- •Do not have a type of colorectal cancer known as dMMR/MSI-H.
- •Do not have a BRAF V600E gene mutation.
- •Have cancer that can be measured on a scan.
Exclusion Criteria
- •Have cancer that has spread to the brain, spinal cord, or surrounding areas and has not been treated.
- •Had other active cancer in the past 2 years (except low-risk cases that have been cured locally).
- •Have serious heart problems, such as a recent heart attack, stroke, blocked arteries, uncontrolled high blood pressure, or certain genetic heart rhythm issues.
- •Have already had checkpoint inhibitors, CD137 agonists, or chemotherapy.
Arms & Interventions
OXALIPLATIN
Intervention: OXALIPLATIN (Drug)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Intervention: IRINOTECAN HYDROCHLORIDE TRIHYDRATE (Drug)
FLUOROURACIL
Intervention: FLUOROURACIL (Drug)
CALCIUM FOLINATE
Intervention: CALCIUM FOLINATE (Drug)
CAPECITABINE, CAPECITABINE
Intervention: CAPECITABINE (Drug)
BNT327 20 mg ml, BNT327 50 mg ml
Intervention: BNT327 20 mg ml (Drug)
BNT327 20 mg ml, BNT327 50 mg ml
Intervention: BNT327 50 mg ml (Drug)
BEVACIZUMAB
Intervention: BEVACIZUMAB (Drug)
Outcomes
Primary Outcomes
Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).
Secondary Outcomes
- Phase 2: To assess all available data including how effective, safe and tolerable the study drug is to arrive at a dose.
- Phase 3: To evaluate how long patients live (OS) and how long the study drug effects on the tumor growth last after it is given (DOR).
Investigators
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company