MedTrace Logo

Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

NCT04165772 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-05-13

No results posted yet for this 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

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

Interventions

DRUG

TSR-042 or Dostarlimab

Patients will be given TSR-042/Dostarlimab at a dose of 500mg IV, over 30 minutes Q 3 weeks.

DRUG

capecitabine or 5-FU

Capecitabine 825mg/m2 BID concurrently with radiation per standard radiation guidelines. If patient is unable to tolerate oral medication, infusional 5-FU is an acceptable alternative.

RADIATION

Intensity Modulated Radiation Therapy (IMRT)

The radiation dose is 5400 cGy to the tumor and surrounding nodes 4700 cGy to the pelvis, with an integrated boost to the primary tumor and involved nodes of receiving 5400cGy in 27fx.

Sponsors & Collaborators

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165772 on ClinicalTrials.gov