NCT04139902

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

PHASE II NEOADJUVANT STUDY OF PD-1 INHIBITOR DOSTARLIMAB (TSR-042) VS. COMBINATION OF TIM-3 INHIBITOR COBOLIMAB (TSR-022) AND PD-1 INHIBITOR DOSTARLIMAB (TSR-042) IN RESECTABLE STAGE III OR OLIGOMETASTATIC STAGE IV MELANOMA (NEO-MEL-T)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized phase II neoadjuvant study comparing neoadjuvant therapy with PD-1 inhibitor Dostarlimab (TSR-042) to the PD-1/TIM-3 inhibitor combination Dostarlimab (TSR-042)/TSR-022 in patients with resectable regionally advanced or oligometastatic melanoma. Patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node (LN) and/or in-transit and/or oligometastatic disease who have yet to undergo definitive surgery are eligible to enroll. Suitable patients will be identified pre-operatively. Patients will undergo screening evaluation consisting of systemic/CNS staging scans, tumor biopsy, blood studies to confirm suitability. Subjects will receive neoadjuvant therapy (Dostarlimab (TSR-042) or Dostarlimab (TSR-042)/TSR-022 combination for 6 weeks prior to planned surgery (pre-operative phase). Surgery will occur 1-4 weeks after completion of pre-operative therapy. After recovery from surgery subjects will receive Dostarlimab (TSR-042) (Post-Operative phase) for approximately 48 weeks; for a total of 54 weeks of study drug(s) administration in total.

Conditions

• Melanoma Stage III
• Melanoma Stage IV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-12
• Primary completion: 2025-09-29
• Completion: 2029-12-15
• First posted: 2019-10-25
• Last updated: 2025-10-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study