Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07058012 · ClinicalTrials.gov registry record · Phase 2
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
A Phase 2 study, sponsored by NSABP Foundation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT07058012: Recruiting Phase 2 study, sponsored by NSABP Foundation.
NCT07058012 is a Phase 2 study that is actively recruiting participants, run by NSABP Foundation. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07058012, a Phase 2 study, is actively recruiting participants, sponsored by NSABP Foundation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the proportion of patients who convert from ctDNA positive at baseline (a condition of eligibility) to ctDNA negative at the 12 week timepoint
Interventions
- DRUG Cemiplimab
- DRUG cemiplimab plus fianlimab
- DRUG cemiplimab + REGN7075
- OTHER ctDNA testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2026-04-17 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 2 |
What NCT07058012 shows while recruiting
NCT07058012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 4 interventions - of which Cemiplimab is the first listed.
NCT07058012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07058012 about?
NCT07058012 is a clinical study titled "A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)". 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 o...
What is the current status of trial NCT07058012?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2026-04-17. Estimated completion is 2029-06-01.
What interventions are being tested in trial NCT07058012?
The interventions under investigation include: Cemiplimab (DRUG), cemiplimab plus fianlimab (DRUG), cemiplimab + REGN7075 (DRUG), ctDNA testing (OTHER).
Who is sponsoring clinical trial NCT07058012?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07058012's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05798897 · 79 participants · Phase 1
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
- NCT06042439 · 79 participants · NA
AM vs PM Exercise Training
- NCT06223555 · 79 participants · NA
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI