SHIVA02 trial: Using patients as their own controls to assess efficacy of therapies based on molecular profiling in patients with refractory cancer
PURPOSE: 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 AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors
- Romain Geiss
- Vincent Servois (ORCID: https://orcid.org/0000-0002-8378-8432)
- Philippe A. Cassier (ORCID: https://orcid.org/0000-0003-3857-1688)
- Céline Callens (ORCID: https://orcid.org/0000-0003-3377-4937)
- Pauline du Rusquec (ORCID: https://orcid.org/0000-0001-5803-4850)
- Sylvain Dureau (ORCID: https://orcid.org/0000-0002-7104-185X)
- Laurence Raizonville
- Elodie Girard (ORCID: https://orcid.org/0000-0001-8737-5371)
- Éléonore Frouin (ORCID: https://orcid.org/0000-0002-7631-188X)
- Ivan Bièche (ORCID: https://orcid.org/0000-0002-2430-5429)
- Philippe Hupé (ORCID: https://orcid.org/0000-0001-8468-3424)
- Marie‐Paule Sablin (ORCID: https://orcid.org/0000-0003-4345-1576)
- Nicolas Servant (ORCID: https://orcid.org/0000-0003-1678-7410)
- Maud Kamal (ORCID: https://orcid.org/0000-0003-1466-0950)
- Fanny Coffin
- Odette Mariani (ORCID: https://orcid.org/0000-0002-3517-4399)
- Antoîne Italiano (ORCID: https://orcid.org/0000-0002-8540-5351)
- Christophe Le Tourneau (ORCID: https://orcid.org/0000-0001-9772-4686)
- Julien Masliah‐Planchon (ORCID: https://orcid.org/0000-0002-5596-3926)
- Laëtitia Chanas
- Célia Dupain (ORCID: https://orcid.org/0000-0001-6248-140X)
- Julien Roméjon
- Jerzy Klijanienko (ORCID: https://orcid.org/0000-0001-9706-7241)
- Édith Borcoman (ORCID: https://orcid.org/0000-0002-5393-5657)
- Samia Melaabi
- Xavier Paolettí (ORCID: https://orcid.org/0000-0002-1250-0040)
- Zahra Ajgal (ORCID: https://orcid.org/0000-0002-2322-9612)
- Samantha Antonio
Institutions
- Institut Gustave Roussy (FR)
- Centre Léon Bérard (FR)
- Institut Bergonié (FR)
- Institut Curie (FR)
Publication Details
- Journal
- Cancer Research Communications
- Published
- 2026-09-15
- DOI
- https://doi.org/10.1158/2767-9764.crc-26-0225
- Primary Topic
- Cancer Genomics and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 0.00