OncoMatch/Clinical Trials/NCT06959550
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Is NCT06959550 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Ivonescimab for metastatic colorectal cancer.
Treatment: Ivonescimab — The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 deficient mismatch repair
dMMR or MSI-H per local testing (Cohort 1)
Required: MSH2 deficient mismatch repair
dMMR or MSI-H per local testing (Cohort 1)
Required: MSH6 deficient mismatch repair
dMMR or MSI-H per local testing (Cohort 1)
Required: PMS2 deficient mismatch repair
dMMR or MSI-H per local testing (Cohort 1)
Required: MSI high microsatellite instability
dMMR or MSI-H per local testing (Cohort 1)
Required: MLH1 proficient mismatch repair
pMMR or non-MSI-H per local testing (Cohorts 2 and 3)
Required: MSH2 proficient mismatch repair
pMMR or non-MSI-H per local testing (Cohorts 2 and 3)
Required: MSH6 proficient mismatch repair
pMMR or non-MSI-H per local testing (Cohorts 2 and 3)
Required: PMS2 proficient mismatch repair
pMMR or non-MSI-H per local testing (Cohorts 2 and 3)
Required: MSI microsatellite stable
pMMR or non-MSI-H per local testing (Cohorts 2 and 3)
Required: KRAS extended RAS status known
Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only)
Required: NRAS extended RAS status known
Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only)
Required: BRAF status known
Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only)
Disease stage
Metastatic disease required
advanced, metastatic adenocarcinoma of colon or rectum
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor (anti-PD-1, anti-CTLA-4) — MSI-H/dMMR cohort only
Demonstrated radiographic or clinical disease progression following treatment with immune checkpoint inhibitors including anti-PD-1 +/- anti-CTLA-4 therapy. Must have received at least 2 doses of a PD1/PD-L1 inhibitor. Progressive disease either during therapy or within 3 months of last dose of therapy.
Must have received: fluoropyrimidine — Cohorts 2 and 3 only
Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
Must have received: irinotecan — Cohorts 2 and 3 only
Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
Must have received: oxaliplatin — Cohorts 2 and 3 only
Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
Cannot have received: immune checkpoint inhibitor (PD-1, PD-L1, CTLA-4)
Exception: MSI-H/dMMR tumors
Except for MSI-H/dMMR tumors, prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors (Cohorts 2 and 3 only).
Lab requirements
Blood counts
Platelet count ≥100,000 /mm3, Hemoglobin ≥9 g/dL, WBC ≥2000/μL, ANC ≥1500/mm3 without red blood cell transfusion or growth factor administered within 7 days of screening CBC
Kidney function
Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min (Cockroft-Gault formula)
Liver function
Total bilirubin ≤1.5 x ULN (≤3 x ULN if Gilbert's syndrome); ALT/AST ≤2.5x ULN (≤5 x ULN for patients with liver involvement)
Adequate hematologic and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06959550 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 deficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 deficient mismatch repair is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify