Abstract
A multicenter phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): Results of expansion cohorts
Journal of clinical oncology, Vol.38(15_suppl), pp.11511-11511
05/20/2020
DOI: 10.1200/JCO.2020.38.15_suppl.11511
Abstract
11511
Background: In the open-label multicenter phase II study, A091401, nivolumab (N) and nivolumab+ipilimumab (N+I) demonstrated a confirmed response rate (RR) of 5% and 16%, respectively in patients (pts) with advanced sarcoma (D’Angelo SP et al Lancet Oncology 2018). Responses occurred in undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, leiomyosarcoma, sarcoma not otherwise specified and alveolar soft part sarcoma. Here, we report efficacy of N and N+I, in each of 3 expansion cohorts [gastrointestinal stromal tumor (GIST), UPS and dedifferentiated liposarcoma (DDLS)]. Methods: Pts refractory to ≥ 1 regimen(s) were randomized (non-comparative) to receive either N [N (3 mg/kg q2W)] or N+I [N (3 mg/kg Q3W x4, then Q2W) plus I (3 mg/kg q3W x4)]. The primary endpoint was 6 month confirmed RR (RECIST v1.1). For UPS and DDLS, 2 confirmed responses in the 1st 12 evaluable pts was needed (85% power, 1-sided alpha=0.15, 5 v 25% RR). For GIST, a confirmed response in the 1st 9 evaluable pts expanded enrollment to 24 (80% power, 1-sided alpha=0.10, 5 v 20% RR). Other endpoints: adverse events (AEs, TRAEs), progression-free and overall survival (PFS, OS), and correlatives. Results: See table. Clinical trial information: NCT02500797 . Conclusions: Neither N or N+I lead to confirmed responses in GIST. In DDLS and UPS, the primary response endpoint was met with N+I but not with N alone (RR 14% for N+I vs. 7% and 8% for N alone). For the GIST cohort TRAE was higher with N+I, holding enrollment as required per protocol. There remains a pressing need to determine genomic and clinical biomarkers of response, resistance and toxicity. Correlative analyses (whole exome sequencing, multiplex IHC and RNAseq) are in progress. Support: U10CA180821, U10CA180882; ClinicalTrials.gov Identifier: NCT02500797. [Table: see text]
Details
- Title: Subtitle
- A multicenter phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): Results of expansion cohorts
- Creators
- James Lin Chen - The Ohio State UniversityMichelle R. Mahoney - Mayo ClinicSuzanne George - Dana-Farber Cancer InstituteCristina R. Antonescu - Memorial Sloan Kettering Cancer CenterDavid A. Liebner - The Ohio State UniversityBrian Andrew Van Tine - Washington University in St. LouisMohammed M. Milhem - University of IowaWilliam D. Tap - Memorial Sloan Kettering Cancer CenterHoward Streicher - National Institutes of HealthGary K. Schwartz - Columbia UniversitySandra P. D'Angelo - Memorial Sloan Kettering Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.38(15_suppl), pp.11511-11511
- DOI
- 10.1200/JCO.2020.38.15_suppl.11511
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- DOI: 10.13039/100000002, name: U.S. National Institutes of Health
- Language
- English
- Date published
- 05/20/2020
- Academic Unit
- Internal Medicine; Hematology, Oncology, and Blood & Marrow Transplantation
- Record Identifier
- 9984363296702771
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