SALVO: Single-arm trial of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma

Lisa A. Kottschade; Gregory Russell Pond; Anthony J. Olszanski; Yousef Zakharia; Evidio Domingo-Musibay; Ralph J. Hauke; Brendan D. Curti; Sarah Schober; Mohammed M. Milhem; Matthew Stephen Block; Robert R. McWilliams

doi:10.1200/JCO.2022.40.16_suppl.9573

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SALVO: Single-arm trial of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma

Abstract

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SALVO: Single-arm trial of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma

Lisa A. Kottschade, Gregory Russell Pond, Anthony J. Olszanski, Yousef Zakharia, Evidio Domingo-Musibay, Ralph J. Hauke, Brendan D. Curti, Sarah Schober, Mohammed M. Milhem, Matthew Stephen Block, …

Journal of clinical oncology, Vol.40(16_suppl), pp.9573-9573

06/01/2022

DOI: 10.1200/JCO.2022.40.16_suppl.9573

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Abstract

9573 Background: Mucosal melanoma is a rare, highly aggressive form of melanoma with extremely high recurrence rates, despite definitive surgical resection. Median RFS has been reported to be 5.4m, with RFS rates at 1 and 2 years of 10%, and 0%, respectively (Lian B, Si L, Cui C, et al. Phase II Randomized Trial Comparing High-Dose IFN-α2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma. Clinical Cancer Research 2013, 19(16):4488-4498). Currently there is no consensus on recommendations for adjuvant therapy. Data on the use of immune checkpoint inhibitors (ICI) adjuvantly is lacking. Methods: We performed a single arm, multicenter clinical trial using “flip dose” ipilimumab (1mg/kg q3w x4 cycles),and nivolumab (3 mg.kg q3w x4 cycles), then Nivolumab 480 mg q4w x 11 cycles to complete a year of adjuvant therapy. The primary endpoint was recurrence-free survival (RFS), and the study had 85% power to detect an improvement in RFS between 5.5 and 9.5 months using a one-sided log rank test. Participants must have had R0/R1 resection <90 days prior to registration, and no prior systemic therapy (adjuvant radiation allowed), ECOG 0/1, no uncontrolled significant autoimmune disease or other invasive cancer. Patients were recruited through the Midwest Melanoma Partnership/Hoosier Oncology Network. Results: From 9/17 to 8/21, 44 patients were approached at 6 centers. Of these 9 were ineligible, and 35 were enrolled. Of these, 29 (83%) had R0 resections, and 7 (20%) had adjuvant radiation prior to enrollment. As of Dec 2021, 31 patients have completed the treatment phase. Of the 35 patients treated on study, 20 patients have recurred (7 local, 5 distant, 3 regional, 5 sites unconfirmed), 6 stopped therapy due to adverse effects, and 8 have died. The mean age of patients was 65.8 years and 21 (60.0%) were female. The primary site of disease was vulvovaginal N=12 (32.4%) patients, sinonasal N= 11 (29.7%), anorectal N= 9 (24.3%) and other site N= 5 (13.5%). Adjuvant radiation had been given in 7 pts. Driver mutations were rare, with only 3 (8.6%) patients having a KIT mutation, and one patient (2.9%) each having a NRAS or BRAF mutation. RFS rates at 1 and 2 years were 50% (95% CI 31-66%) and 37% (95% CI 19-55%), with OS rates at 1 and 2 years of 87% (95% CI 68-95%) and 68% (95% CI 46-83%). Median RFS was 10.3 m (95% CI5.7-25.8). Most common grade 3 adverse events were diarrhea (14%), hypertension (14%), hyponatremia (11%), with no grade 4/5 toxicities. Conclusions: Flip dose ipilimumab and nivolumab after resection is associated with outcomes improved over previously reported outcomes in the absence of therapy. Long term follow up is ongoing as are subgroup analyses and correlative studies. Clinical trial information: NCT03241186.

Details

Title: Subtitle: SALVO: Single-arm trial of ipilimumab and nivolumab as adjuvant therapy for resected mucosal melanoma
Creators: Lisa A. Kottschade - Mayo Clinic, Rochester, MN;
Gregory Russell Pond - Ontario Clinical Oncology Group
Anthony J. Olszanski - Fox Chase Cancer Center
Yousef Zakharia - University of Iowa
Evidio Domingo-Musibay - Mayo Clinic, Rochester, MN;
Ralph J. Hauke - Nebraska Cancer Specialists
Brendan D. Curti - Providence Portland Medical Center
Sarah Schober - Fox Chase Cancer Center
Mohammed M. Milhem - University of Iowa
Matthew Stephen Block - Mayo Clinic, Rochester, MN;
Robert R. McWilliams - Mayo Clinic, Rochester, MN;
Resource Type: Abstract
Publication Details: Journal of clinical oncology, Vol.40(16_suppl), pp.9573-9573
DOI: 10.1200/JCO.2022.40.16_suppl.9573
ISSN: 0732-183X
eISSN: 1527-7755
Grant note: name: Bristol Myers Squibb.
Language: English
Date published: 06/01/2022
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984363459002771

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