Clinical Trials Logo
  1. Home
  2. Melanoma Stage Iv
  3. 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

Melanoma Stage IV Clinical Trial

Official title:
Randomized 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)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04139902
Study type Interventional
Source University of Pittsburgh
Contact Diwakar Davar, MD
Phone 412-623-7368
Email davard@upmc.edu
Status Recruiting
Phase Phase 2
Start date June 12, 2020
Completion date April 15, 2029
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04330430 - Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease Phase 2
Withdrawn NCT04007588 - A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Recruiting NCT04562129 - IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients Phase 2
Recruiting NCT04990726 - Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05370807 - A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma Phase 2
Recruiting NCT04045691 - Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Not yet recruiting NCT05068453 - Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis Phase 1
Not yet recruiting NCT05070221 - Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis Phase 1
Recruiting NCT03353402 - Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy Phase 1
Recruiting NCT04513028 - Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma N/A
Recruiting NCT05598853 - Intrathecal Double Checkpoint Inhibition Phase 1
Recruiting NCT04521075 - A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC Phase 1/Phase 2
Recruiting NCT06425926 - Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03153085 - A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma Phase 2
Recruiting NCT04741997 - Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma Early Phase 1
Recruiting NCT03991130 - High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma Phase 2
Active, not recruiting NCT04526899 - Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Phase 2