Centre Hospitalo-Universitaire Saint André, Bordeaux, France
Marine Gross-Goupil , Felix Lefort , Mathieu Larroquette , Julien Asselineau , Eric Frison , Laurence Albiges , Alain Ravaud
Background: Treatment of mRCC consists of combination of either Immune Checkpoint Inhibitor (ICI)-Tyrosine Kinase Inhibitor (TKI) for all IMDC prognosis group, or ICI-ICI for intermediate and unfavorable IMDC groups. Treatments are maintained until disease progression or toxicity for a total duration of 2 years for ICI, in routine. Acceptability and feasibility of treatment pause of the TKI, with no detrimental effect on efficacy were reported in the prospective STAR trial. The good-risk population is characterized by prolonged survival, close to that reported in the intermediate risk population group with a single adverse prognostic factor. Therefore, a pause of ICI-TKI could improve quality of life, safety, and total cost of care without detrimental impact on oncologic outcomes. Methods: This non-inferiority, randomized, open-label, multicenter, parallel-group trial (NCT05219318) aims to compare treatment pause versus treatment continuation in good or intermediate risk mRCC patients with only one prognostic factor and a confirmed objective response (complete or partial) at 12 months of treatment with ICI-TKI. 372 patients (186 in France) will be recruited in tertiary hospitals and randomized in a 1:1 ratio with stratification by center, prognostic group (good/intermediate) and response (complete/partial). The primary objective is to test the non-inferiority of treatment pause versus continuation, with the estimation of the difference in 12-month progression rate after randomization, and its one-sided 97.5% confidence interval. The non-inferiority margin is set at 15%. An interim safety data monitoring at 6 months after randomization of the first third of participants (i.e. 60 per arm) will check progression rate after treatment pause. A formal interim futility analysis will be performed when 50% of the study sample reaches the primary outcome time point, using a Bayesian predictive power stopping rule and a futility threshold set at 20%. Secondary objectives are overall safety and tolerability, health-related quality of life, anxiety and depression, quality-adjusted survival, 2-year overall and progression-free survival. Others objectives include progression patterns (site, known lesions, or/and new lesions), subsequent treatment (type, efficacy), in the experimental arm. In France, healthcare resource utilization and costs at 12 months will be compared. The first participant was randomized in January 2023. 27 centers in France were selected and are gradually/progressively opening. The opening of European centers is being planned. Health Ministry and National Cancer Institute Funds. Clinical trial information: NCT05219318.
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