drugset / Trial / NCT02775851
Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Timeline
- Start
- 2017-02-06
- Primary completion
- 2023-04-14
- Completion
- 2027-05-15
Outcome
Met primary endpoint
registry analysis (superiority test); Cohort A: Resectable - Pembrolizumab, Surgery; p <0.001; One-sided Exact Binomial NCT02775851 ↗
registry analysis (superiority test); Cohort B: Unresectable - Pembrolizumab; p <0.001; One-sided Exact Binomial NCT02775851 ↗
Publications
- Kendra KL, Bellasea SL, Eroglu Z, Hu-Lieskovan S, Campbell KM, Carson WE 3rd, Wada DA, Plaza JA, In GK, Ikeguchi A, Hyngstrom J, Brohl AS, Chmielowski B, Khushalani NI, Markowitz J, Monroe M, Contreras CM, Bowles T, Norman K, Medina E, Gonzalez CR, Baselga-Carretero I, Garcilazo IP, Vega-Crespo A, Chen JM, Deen NNA, Patel SP, Grossmann KF, Sondak VK, Sharon E, Moon J, Wu MC, Ribas A. Neoadjuvant PD-1 blockade in surgically resectable desmoplastic melanoma: cohort A of the phase 2 SWOG S1512 trial. Nat Cancer. 2026 Feb;7(2):272-282. doi: 10.1038/s43018-025-01113-y. Epub 2026 Jan 29.
- Kendra KL, Bellasea SL, Eroglu Z, Hu-Lieskovan S, Campbell KM, Carson WE 3rd, Wada DA, Plaza JA, Sosman JA, In GK, Ikeguchi A, Hyngstrom J, Brohl AS, Khushalani NI, Markowitz J, Negrea G, Kasbari S, Doolittle GC, Swami U, Roberts T, Mathew BN, Medina E, Baselga-Carretero I, Gonzalez CR, Garcilazo IP, Vega-Crespo A, Chen JM, Naser Al-Deen N, Patel SP, Sharon E, Moon J, Wu MC, Ribas A. Anti-PD-1 therapy in unresectable desmoplastic melanoma: the phase 2 SWOG S1512 trial. Nat Med. 2025 Nov;31(11):3668-3674. doi: 10.1038/s41591-025-03875-5. Epub 2025 Aug 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |