OncoMatch/Clinical Trials/NCT07829081
Research on Effective Strategies After Immunotherapy for Mismatch Repair-deficient Early-stage GI Tumors
Is NCT07829081 recruiting? Yes, currently enrolling (Oct 2026).
This cohort study is divided into two parts: Part A: Registry Cohort All patients with non-metastatic, MMRd/MSI-H colorectal cancers (and other gastrointestinal cancers for exploratory analysis) who have signed the general research consent will be included in a prospective registry. This includes patients who undergo primary surgical resection (+/- neoadjuvant/adjuvant therapy) or following immunotherapy, regardless of response. Part A is a multicenter observational registry with both prospective and retrospective enrolment. Prospective enrolment includes eligible patients entered into the registry after activation of the study at the respective participating site. Retrospective enrolment includes eligible patients diagnosed on or after 1 January 2024 whose clinical data were generated prior to registry activation. Both prospectively and retrospectively enrolled patients contribute to the registry analyses. Part B: Active Surveillance Cohort (Surveillance Study) A subset of patients from Part A who achieve a complete or near-complete response to ICI therapy, wish to avoid surgery, and are deemed appropriate for non-operative management by a multidisciplinary tumor board are offered inclusion in a phase II surveillance study (Part B). Patients enrolled in Part B will be analysed for the primary endpoint.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 loss
Required: MSH2 loss
Required: MSH6 loss
Required: PMS2 loss
Prior therapy
Must have received: immune checkpoint inhibitor (nivolumab, ipilimumab, pembrolizumab, atezolizumab) — primary treatment
Therapy with immune checkpoint inhibitor (ICI) as primary treatment, either: Combination ICI therapy (e.g., anti-PD-1 plus anti-CTLA-4 such as nivolumab + ipilimumab) or Single-agent ICI therapy (e.g., pembrolizumab, atezolizumab, or other anti- PD(L)1 agents)
Cannot have received: systemic therapy for current colon cancer diagnosis before ICI treatment
Exception: biopsy
Any prior systemic therapy, radiotherapy or surgery for the current colon cancer diagnosis before ICI treatment (except biopsy)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07829081 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for current colon cancer diagnosis before ICI treatment disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss 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