Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 12, 2020

Primary Completion Date

September 29, 2025

Study Completion Date

December 15, 2029

Conditions
Melanoma Stage IIIMelanoma Stage IV
Interventions
DRUG

Dostarlimab (TSR-042) (singly)

"If patients are randomized to Dostarlimab (TSR-042) alone, during the Pre-operative Phase, 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.~Surgery will occur 1-4 weeks after completion of the pre-operative phase.~During the Post-operative phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks (Cycles 5-10) for approximately 48 weeks."

DRUG

Dostarlimab (TSR-042) and TSR-022 (combination)

"If patients are randomized to the combination, Dostarlimab (TSR-042) and TSR-022, during the Pre-operative Phase, Dostarlimab (TSR-042) 500mg and TSR-022 300mg will be administered through an IV over 30 minutes on Cycle 1 Day 1 and then again on Cycle 2 Day 1.~Surgery will occur 1-4 weeks after completion of the pre-operative phase.~During the Post-operative Phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks."

Trial Locations (5)

15232

UPMC Hillman Cancer Center, Pittsburgh

15301

UPMC Hillman Cancer Center Washington, Washington

20007

Georgetown University Medical Center, Washington D.C.

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Tesaro, Inc.

INDUSTRY

lead

Diwakar Davar

OTHER