Untreated, Unresectable or Metastatic Colorectal Cancer
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DRUGCAPECITABINE
DRUGBEVACIZUMAB
DRUGCALCIUM FOLINATE
DRUGOXALIPLATIN
DRUGBNT327 50 mg ml
DRUGBNT327 20 mg ml
DRUGFLUOROURACIL
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Outcome results
None listed