Immune Resistance Interrogation Study

Titre officiel

Immune Resistance Interrogation Study

Sommaire:

Il s’agit d’une étude de recherche prospective qui portera sur des patients dont la maladie a progressé pendant leur traitement le plus récent par immunothérapie. Cette étude vise à déterminer si les patients qui ne répondent pas à l’immunothérapie, par rapport aux patients qui y répondent initialement, mais qui, après un certain temps, montrent une progression de leur maladie, présentent des profils génomiques, transcriptomiques, épigénétiques et immunophénotypiques différents. Les patients subiront une biopsie unique de tumeur fraîche. Des échantillons de sang en série (la quantité totale de sang prélevée ne devrait pas dépasser 50 mL ou 3 mL/kg, la moindre de ces deux mesures, sur une période de 8 semaines), un échantillon de tissu archivé (si disponible), et un échantillon de selles seront recueillis.

Description de l'essai

Primary Outcome:

• Genomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Transcriptomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Immunophenotypic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Epigenetic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours

Secondary Outcome:

• Genomic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Transcriptomic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Immunophenotyping changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Epigenetic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy

Although there has been some success with the use of immunotherapy treatments specifically antibodies that block the programmed death 1 receptor (PD1/L1), the majority of cancer patients either fail to respond (primary resistance) or respond initially but progress after a period of time (acquired resistance) when treated with immunotherapy agents. The hypothesis being tested is whether patients who have primary versus acquired resistance to immunotherapy demonstrate different genomic, transcriptomic, immunophenotypic and/or epigenetic profiles.

Voir cet essai sur ClinicalTrials.gov