drugset / Trial / NCT02519322
Neoadjuvant and Adjuvant Checkpoint Blockade
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab alone or in combination with ipilimumab or relatlimab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Timeline
- Start
- 2016-02-02
- Primary completion
- 2023-01-26
- Completion
- 2023-01-26
Publications
- Burton EM, Milton DR, Tetzlaff MT, Wani K, Ross MI, Postow MA, Lazcano R, Glitza IC, Wong MK, Patel SP, Diab A, Gershenwald JE, McQuade JL, Betof Warner A, Prieto VG, Lee JE, Goepfert RP, Fisher SB, Song A, Malke J, Simon JM, Ariyan C, Torres-Cabala CA, Davies MA, Lazar A, Wargo JA, Tawbi HA, Amaria RN. Long-Term Survival and Biomarker Analysis Evaluating Neoadjuvant Plus Adjuvant Relatlimab (anti-LAG3) and Nivolumab (anti-PD1) in Patients With Resectable Melanoma. J Clin Oncol. 2025 Sep 10;43(26):2856-2862. doi: 10.1200/JCO-25-00494. Epub 2025 Jul 10.
- Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Relatlimab | Monoclonal antibody | — | Intravenous |