TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexAll
- Healthy volunteersNo
You may be able to join if
- Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally
- At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver
- Tumor confirmed as microsatellite stable (MSS)/proficient mismatch repair (pMMR) per a FDA-approved assay (Caris MI Cancer Seek®, FoundationOne® CDx, or Tempus xT CDx).
- Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated
- ECOG performance status 0-1 and life expectancy ≥12 weeks
- Adequate organ and marrow function:
- ANC ≥1.5 × 10⁹/L
- Platelets ≥100 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- AST/ALT ≤2.5 × ULN
- Total bilirubin ≤1.5 × ULN
- Creatinine clearance ≥ 40 mL/min, as measured or calculated per local institutional standards.
- Albumin ≥3 g/dL
- PT/PTT ≤1.5 × ULN
- Willing and able to provide written informed consent
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during study participation
You cannot join if
- Tumor is dMMR/MSI-high
- Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents
- Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)
- Refractory ascites requiring frequent paracentesis or recent escalation of diuretics
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc >480 ms
- Active or untreated brain metastases or leptomeningeal disease
- Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)
- Receipt of prior anti-cancer therapy within protocol-defined washout periods, including:
- Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
- Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
- Small molecules/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.
- Known hypersensitivity to study drugs or excipients
- History of or active interstitial lung disease or pneumonitis requiring systemic steroids
- Prior allogeneic transplant (organ, stem cell, or bone marrow)
- Active or recent autoimmune disease requiring systemic treatment
- Requirement for systemic corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows
- Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy
- Recent SARS-CoV-2 infection within protocol-defined timeframe
- Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g/g), or other clinically significant uncontrolled medical conditions
- Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction
- Psychiatric or substance use disorders that may interfere with study participation
- Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study
- Pregnant or breastfeeding women, or those planning pregnancy during the study