Journal article
SALVO: Single-arm phase II study of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma
Journal of clinical oncology, Vol.38(5_suppl), pp.TPS65-TPS65
02/10/2020
DOI: 10.1200/JCO.2020.38.5_suppl.TPS65
Abstract
Abstract only
TPS65
Background: Mucosal melanoma is a rare and, therefore, poorly studied malignancy. Patients with resected primary tumors have a median time to recurrence of 5.5 months. While no one adjuvant therapy is of proven benefit for patients, immunotherapy has shown activity in metastatic mucosal melanoma. Methods: We are performing a single arm, phase II clinical trial through the Midwest Melanoma Partnership/Hoosier Cancer Research Network (6 sites) for resected mucosal melanoma. The primary endpoint is recurrence free survival (RFS), and it will include 36 subjects. Patients must have had an R0 or R1 resection of a mucosal melanoma (sinonasal, anorectal, vulvar, or other), and register within 90 days of surgery. Adjuvant radiation is allowed prior to registration but not required. Therapy consists of ipilimumab (1 mg/kg) and nivolumab (3 mg/kg) IV q3w x 4, then 480 mg nivolumab x 1 year. Statistical power is calculated to be 85% to detect a change in RFS from 5.5 months to 9.5 months, with a one sided alpha of 0.05. Enrollment began Sept 2017, with current participation from 6 large volume centers in the United States, with 17 patients enrolled as of Sept 2019. Full accrual is anticipated to complete by year end 2020. Patients will be followed for RFS and OS. Translational studies will include mutational burden, c-kit, BRAF, NRAS status, and serum markers of immunity -- including soluble PD-L1 and Bim. Clinical trial information: NCT03241186.
Details
- Title: Subtitle
- SALVO: Single-arm phase II study of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma
- Creators
- Robert R. McWilliams - Mayo Clinic in ArizonaShernan Holtan - University of MinnesotaGregory Russell Pond - McMaster UniversityYousef Zakharia - Georgia Regents Medical CenterBrendan D. Curti - Providence Portland Medical CenterEvidio Domingo Musibay - Mayo Clinic, Rochester, MNAnthony J. Olszanski - Fox Chase Cancer CenterLisa A. Kottschade - Mayo Clinic in ArizonaRalph J. Hauke - Nebraska Cancer Specialists
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.38(5_suppl), pp.TPS65-TPS65
- DOI
- 10.1200/JCO.2020.38.5_suppl.TPS65
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- name: Bristol-Myers Squibb.
- Language
- English
- Date published
- 02/10/2020
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984548265702771
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