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NCT04357587 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04357587: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT04357587 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04357587, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer mortality in the United States. The current standard of care (SOC) for locally advanced rectal cancer includes neoadjuvant chemotherapy and radiation followed by surgery. However, great variability exists in patient's response to neoadjuvant chemoradiotherapy with only about 20-25% of patients achieving a complete response while other patients achieve a partial or no treatment response. The purpose of this study is to test the investigational agent, Pembrolizumab, in combination with SOC radiation and Capecitabine (or 5-Fluorouacil) in treatment of patients with mismatch repair deficient locally advanced rectal cancer.
Primary Outcome
Safety endpoint will be defined by rate of AEs as defined by the CTCAE v5.0
Interventions
- DRUG Pembrolizumab
- DRUG Capecitabine
- RADIATION External beam radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2023-09-25 |
| Phase | Phase 1 |
What the finished NCT04357587 record still lists
NCT04357587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04357587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04357587 about?
NCT04357587 is a clinical study titled "Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer". Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer mortality in the United States. The current standard of care (SOC) for locally advanced rectal cancer includes neoadjuvant chemotherapy and radiation followed by surgery. However, great variability exi...
What is the current status of trial NCT04357587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-08-06. Estimated completion is 2023-09-25.
What interventions are being tested in trial NCT04357587?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), External beam radiation (RADIATION).
Who is sponsoring clinical trial NCT04357587?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04357587's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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