Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

Phase 2 Completed 200 enrolled AIO-Studien-gGmbH Bristol-Myers Squibb · collab

NaSingle-groupOpen-labelTreatment

Summary

TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

Timeline

Start: 2016-10
Primary completion: 2021-10
Completion: 2022-10

Outcome

Mixed primary results

paper 39 (36%, 90% CI 28-44; p=0·0080) of 109 patients in the first-line group PMID 37844597 ↗

paper 31 (32%, 24-40; p=0·083) of 98 patients in the second-line group PMID 37844597 ↗

Publications

Grimm MO, Esteban E, Barthelemy P, Schmidinger M, Busch J, Valderrama BP, Charnley N, Schmitz M, Schumacher U, Leucht K, Foller S, Baretton G, Duran I, de Velasco G, Priou F, Maroto P, Albiges L; TITAN-RCC study group. Tailored immunotherapy approach with nivolumab with or without nivolumab plus ipilimumab as immunotherapeutic boost in patients with metastatic renal cell carcinoma (TITAN-RCC): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2023 Nov;24(11):1252-1265. doi: 10.1016/S1470-2045(23)00449-7. Epub 2023 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous