Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Sponsor: M.D. Anderson Cancer Center + Akesobio Australia Pty Ltd, Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
1. Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Eligibility Criteria
Inclusion Criteria: 1. Capable of giving signed informed consent 2. Male and female adult participants 18 years of age or older on day of signing informed consent. 3. Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum. 4. Known MMR or MSI status performed by local standard of practice. (e.g., IHC and/or PCR, next-generation sequencing) 5. Cohort-specific criteria * Cohort 1: MSI-H/dMMR: ICI-refractory * dMMR or MSI-H per local testing * Demonstrated radiographic or clinical disease progression following treatment with immune checkpoint inhibitors including anti-PD-1 +/- anti-CTLA-4 therapy. If progression occurred after first imaging assessment, then pseudo-progression should be excluded by concurrent carcinoembryonic antigen (CEA) or other tumor marker or ctDNA elevation, or clinical symptom progression, or short-interval repeat imaging confirming progression. * Must have received at least 2 doses of a PD1/PD-L1 inhibitor.…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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