GoKawiilStudy sponsorship, authorizations and ethics
This study was an investigator initiated trial sponsored by Gustave Roussy and covered by a Biomedical Research Promoter Civil Liability insurance contract (contract 124.895) in accordance with the provisions of the French law (Decree 2006-477 of 26 April 2006 and Article L.1121-10 of the French Public Health Code). This study was approved by the French Health Agency (Agence Nationale de Sécurité du Médicament) on 29 March 2016 (ANSM 160104A-12) and by the national ethics committee (Comité de Protection des Personnes Ile-de-France VIII) on 16 February 2016 (CPP 160215). The study was registered on EUDRACT (2015-005429-37) on 30 November 2015 and on ClinicalTrials.gov (NCT02857569) on 19 July 2016. The study was conducted in accordance with the Declaration of Helsinki and international Conference on Harmonization Good Clinical Practice (GCP). All investigators were GCP certified. The study was approved by the Gustave Roussy institutional review board (CSET 2015/2334) on 24 November 2015. All patients provided written informed consent prior enrollment in the trial and before any study specific procedure for clinical data and ancillary analysis anonymous use. Ipilimumab and nivolumab were supplied by Bristol Myers Squibb.
Objectives
The study aimed to evaluate the 6-month treatment tolerance defined as the treatment-related grade 3–4 adverse event-free survival of the combination therapy intratumoural (IT) ipilimumab plus intravenous (IV) nivolumab. The IV ipilimumab plus IV nivolumab (same doses as in phase 1) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.
Secondary objectives were to explore the types of toxicities generated by the combination therapy in the two treatment arms and to evaluate the efficacy of IT ipilimumab in combination with IV nivolumab.
Translational objectives were to demonstrate the lower systemic exposure to ipilimumab in the IT arm and to identify predictive biomarkers of response.
To assess response to treatment using several end-points for efficacy based either on RECIST 1.1, or on immune-related response criteria.
Key eligibility criteria
Main inclusion and non-inclusion criteria are presented below (not exhaustive list, if needed cf. protocol).
Inclusion criteria
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