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

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Rectal AdenocarcinomaClinical Stage: Stage II (T3-4, N-)Stage III (Any T, N+)Solid TumorSolid 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.

Trial Locations (11)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester - Limited Protocol Activities, Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau - Limited Protocol Activities, Uniondale

11702

RECRUITING

New York Cancer and Blood Specialists, Babylon

11725

RECRUITING

Memorial Sloan Kettering Commack - Limited Protocol Activities, Commack

18103

RECRUITING

Lehigh Valley Health Network (Data Collection Only), Allentown

33143

RECRUITING

Baptist Alliance MCI (Data Collection Only), Miami

06102

RECRUITING

Hartford Healthcare (Data Collection), Hartford

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth - Limited Protocol Activities, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen - Limited Protocol Activities, Montvale

All Listed Sponsors
collaborator

Tesaro, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER