CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 79 target
Drug / intervention
Cemiplimab +3 moredrug
Likely dose
Cemiplimab 350mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07058012
NCT07058012Phase 2RecruitingHigh Momentum
CompareCT.gov

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab and Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy

NSABP Foundation Inc·interventional·Posted Jul 10, 2025·Updated Jun 12, 2026

In Brief

A Phase 2 clinical trial evaluating Cemiplimab, cemiplimab plus fianlimab, and 2 other interventions for Colo-rectal Cancer. Currently recruiting, targeting 79 participants across 9 sites.

Signals

Enrolling ahead of pace

Detailed Summary

The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColo-rectal Cancer
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 2Recruiting
2026202720282029
First PostedJul 10, 2025
Enrollment StartApr 17, 2026
Primary CompletionApr 17, 2029
Study CompletionJun 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 12 months agoPrimary completion in 2.8 years

Arms & Interventions

Arm 1active_comparator

cemiplimab

Drug: CemiplimabOther: ctDNA testing
Arm 2active_comparator

cemiplimab plus fianlimab

Drug: cemiplimab plus fianlimabOther: ctDNA testing
Arm 3experimental

cemiplimab plus REGN7075

Drug: cemiplimab + REGN7075Other: ctDNA testing

Interventions

Cemiplimabdrug

Cemiplimab 350mg intravenously

cemiplimab plus fianlimabdrug

Cemiplimab 350mg + Fianlimab 1600mg intravenously

cemiplimab + REGN7075drug

Cemiplimab 350mg + REGN7075 2700mg intravenously

ctDNA testingother

Eligible patients using results for ctDNA-positivity as obtained from a commercial assay run in any CLIA-certified lab will proceed to enrollment and begin treatment. All patients will have confirmation of ctDNA-positivity via the Signatera\^TM assay (Clinical Trial Assay), but treatment may proceed while awaiting confirmatory results.