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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 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04357587
The ClinicalTrials.gov registry entry for NCT04357587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04357587 reports 0 study locations.
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.
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