Welcome to the CORA 2023
Interactive Program
The congress will officially run on Central European Time (CET/GMT+1)
To check the congress times in your local time Click here
145 Presentations
PHASE II CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF INTERLEUKIN-6 RECEPTOR BLOCKER IN COMBINATION WITH IPILIMUMAB AND NIVOLUMAB FOR METASTATIC MELANOMA
Abstract
Background and Aims
Management of immune-related adverse events (irAEs) is challenging as using corticosteroids as first-line therapy can lead to significant morbidity. Our preliminary results suggested a role for interleukin-6/Th17 pathway in both irAEs and immunotherapy resistance. Therefore, we evaluated the safety and efficacy of tocilizumab plus combination immune checkpoint inhibitors (ipilimumab/nivolumab) in previously untreated metastatic melanoma patients.
Methods
Phase II, open-label, single center study (NCT04940299). Participants (n=35) receive subcutaneous tocilizumab 162 mg weekly or bi-weekly for up to 12 weeks as approved for rheumatoid arthritis plus ipilimumab/nivolumab per the standard dosing for melanoma. Objectives: 1) assess grade 3 or higher irAEs; 2) estimate objective response rate (ORR) by RECIST 1.1 and overall survival; and 3) explore biomarkers of toxicity and tumor response/resistance. Safety assessments continue for up to 2 years in participants who discontinue therapy for any reason.
Results
To date, 25 participants have been enrolled; duration of treatment ranged from 6 to 41 weeks. Eleven patients (44%) had grade III/IV irAEs: colitis (20%), hepatitis (16%), pancreatitis (8%), and polymyalgia rheumatica-like and type I diabetes (4% each). Median time to irAE onset was 8.3 weeks (2.7-17.3) and irAEs led to study discontinuation in 4%. There have been no treatment-related deaths. The ORR was 60% including 44% in patients with elevated LDH and disease control rate (CR+PR+SD) was 75%.
Conclusions
Our preliminary data showed a numerically lower rate of grade III/IV irAEs compared to similarly designed ipilimumab/nivolumab melanoma trials without negative impact on efficacy. Ongoing immune analysis will be presented to help further interpret these results.