Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT04139902
Brief 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.
Study:
NCT04139902
Study Brief:
Protocol Section:
NCT04139902