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NCT04165772 · ClinicalTrials.gov registry record · Phase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
A Phase 2 study of Solid Tumor and Solid Tumor, Adult, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 10
- Study locations
NCT04165772: Recruiting Phase 2 study of Solid Tumor and Solid Tumor, Adult, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04165772 is a Phase 2 study of Solid Tumor and Solid Tumor, Adult that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 200 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165772, a Phase 2 study of Solid Tumor and Solid Tumor, Adult, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.
Primary Outcome
To determine the pathologic complete response rate (pCR) or complete clinical response (cCR) rate at 12 months, after PD-1 blockade and with or without chemoradiation in subjects with mismatch repair deficient locally advanced adenocarcinoma.
Conditions Studied
Interventions
- DRUG TSR-042 or Dostarlimab
- DRUG capecitabine or 5-FU
- RADIATION Intensity Modulated Radiation Therapy (IMRT)
Study Locations (10)
New York
- Memorial Sloan Kettering Commack - Limited Protocol Activities - Commack
- Memorial Sloan Kettering Westchester - Limited Protocol Activities - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Limited Protocol Activities - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities - Basking Ridge
- Memorial Sloan Kettering Monmouth - Limited Protocol Activities - Middletown
- Memorial Sloan Kettering Bergen - Limited Protocol Activities - Montvale
Connecticut
- Hartford Healthcare (Data Collection) - Hartford
Florida
- Baptist Alliance MCI (Data Collection Only) - Miami
Pennsylvania
- Lehigh Valley Health Network (Data Collection Only) - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
What NCT04165772 shows while recruiting
NCT04165772 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower).
The record links to 5 conditions, with Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which TSR-042 or Dostarlimab is the first listed.
NCT04165772 lists 10 locations in 5 states (New York, New Jersey, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04165772 about?
NCT04165772 is a clinical study titled "Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors". The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study...
What is the current status of trial NCT04165772?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2019-12-11. Estimated completion is 2026-11-30.
What conditions does trial NCT04165772 study?
This clinical trial studies the following conditions: Solid Tumor, Solid Tumor, Adult, Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-), Stage III (Any T, N+).
What interventions are being tested in trial NCT04165772?
The interventions under investigation include: TSR-042 or Dostarlimab (DRUG), capecitabine or 5-FU (DRUG), Intensity Modulated Radiation Therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT04165772?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04165772 being conducted?
This trial has 10 study locations across Connecticut, Florida, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04165772's enrollment target sits among peer trials
200 38th of 196 higher than 157 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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.
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