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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 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.

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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.

Conditions Studied

Solid Tumor Solid Tumor, Adult Rectal Adenocarcinoma Clinical Stage: Stage II (T3-4, N-) Stage III (Any T, N+)

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

FieldValue
Enrollment Target 200 participants
Start Date 2019-12-11
Est. Completion 2026-11-30
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

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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, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.