Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

February 10, 2020

Primary Completion Date

August 10, 2027

Study Completion Date

August 10, 2027

Conditions
Immunotherapy
Interventions
DRUG

olaparib, durvalumab, tremelimumab

"STEP 1:~Olaparib 300 mg BID during 8 weeks. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food~STEP 2:~Olaparib 300 mg during 4 months as per same requirement as below. Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing."

Trial Locations (8)

21000

Centre Georges François Leclerc, Dijon

Unknown

CHU Amiens, Amiens

CHRU Jean Minjoz, Besançon

Institut Bergonié, Bordeaux

CHU François Mitterrand, Dijon

Institut Hospitalier Franco-Britannique, Levallois-Perret

Centre Oscar Lambret, Lille

Centre Leon Berard, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Centre Georges Francois Leclerc

OTHER