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NCT07281768 · ClinicalTrials.gov registry record · Phase 2
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT07281768: Recruiting Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT07281768 is a Phase 2 study that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07281768, a Phase 2 study, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).
Primary Outcome
Proportion of subjects with a pathologic complete response (pCR) at the time of surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0).
Interventions
- DRUG Cemiplimab
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG REGN7075
- DRUG Fianlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-07 |
| Est. Completion | 2030-07 |
| Phase | Phase 2 |
What NCT07281768 shows while recruiting
NCT07281768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Cemiplimab is the first listed.
NCT07281768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07281768 about?
NCT07281768 is a clinical study titled "Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer". The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-pos...
What is the current status of trial NCT07281768?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2026-07. Estimated completion is 2030-07.
What interventions are being tested in trial NCT07281768?
The interventions under investigation include: Cemiplimab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), REGN7075 (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT07281768?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07281768's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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
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