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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Diwakar Davar
Study ID
NCT04139902
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab (TSR-042) (singly) — DRUG
    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.
  • Dostarlimab (TSR-042) and TSR-022 (combination) — DRUG
    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.

Study Details

The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.

Key Dates

Start date
Jun 12, 2020
Status verified
Oct 2025
Primary completion
Sep 29, 2025
Completion
Dec 15, 2029

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dostarlimab (TSR-042) (singly)
    Pre-Operative Phase: Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1. Post-Operative Phase: Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 doses 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.
  • Experimental: Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination)
    Pre-Operative Phase: Dostarlimab (TSR-042) 500mg and Cobolimab 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. Post-Operative Phase: Dostarlimab (TSR-042) will be administered through an IV over 30 minutes for 4 doses 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. TSR-022 will not be administered.

Primary Outcome Measure

Major Pathologic Response (MPR) [ Time Frame: 5 years (for population) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
UPMC Hillman Cancer Center WashingtonWashingtonPennsylvania15301-

Find similar trials in Washington D.C., DC

By research site
Georgetown University Medical Center· Washington D.C., DCDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUPMC Hillman Cancer Center· Pittsburgh, PAUPMC Hillman Cancer Center Washington· Washington, PA

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