SHIVA02 trial: Using patients as their own controls to assess efficacy of therapies based on molecular profiling in patients with refractory cancer.

Authors

Pauline du Rusquec, Célia Dupain, Romain Geiss, Marie-Paule Sablin, Zahra Castel-Ajgal, Philippe Cassier, Antoine Italiano, Edith Borcoman, Jerzy Klijanienko, Vincent Servois, Laurence Raizonville, Fanny Coffin, Julien Romejon, Philippe Hupé, Laëtitia Chanas, Sylvain Dureau, Eleonore Frouin, Odette Mariani, Samantha Antonio, Céline Callens, Samia Melaabi, Julien Masliah-Planchon, Elodie Girard, Nicolas Servant, Maud Kamal, Ivan Bièche, Xavier Paoletti, Christophe Le Tourneau

Published in

Cancer research communications. Sep 15, 2026. Epub Sep 15, 2026.

Abstract

SHIVA02 is a tissue-agnostic precision medicine basket trial assessing a molecularly targeted strategy in refractory cancer patients using patients as their own-controls to assess the efficacy of the strategy.
Patients with cancers refractory to standard-of-care underwent molecular profiling and received standard therapy followed, if possible, by matched therapy guided by a Molecular Biology Board. Tumor evaluations were performed every 2 months according to RECIST1.1 on both treatments in order to reliably assess the PFS ratio.
Among 263 patients enrolled, molecular profiling was successful in 192 patients (73%), and 34 patients (13%) received matched therapy and were eligible for PFS ratio analyses. The median PFS1 was 2.1 months (95% CI [confidence interval] 1.8 to 3.6) and the median PFS2 was 2.0 months (95% CI 1.8 to 2.7). A PFS ratio exceeding 1.3 or 1.5 was observed in 11 (32%) and 8 (24%) patients, respectively. Overall survival was prolonged in the subgroup of patients evaluable for PFS ratio. Prognostic factors such as ECOG performance status and RMH score significantly influenced overall survival, highlighting the importance of patient selection in precision oncology trials.
Using a prospective and standardized approach for evaluating PFS on both standard and matched therapies, 32% of patients receiving matched therapy benefited from the approach with a PFS ratio > 1.3.

PMID:
42742043
Bibliographic data and abstract were imported from PubMed on 15 Sep 2026.

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