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Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
NCT04165772 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165772
The ClinicalTrials.gov registry entry for NCT04165772 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04165772 reports 10 study locations spanning 5 distinct geographic areas — top geographies include New York, New Jersey, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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+). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04165772?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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