Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumours

Titre officiel

A Phase II Study of Olaparib and Durvalumab (MEDI 4736) in Patients With IDH-Mutated Solid Tumours

Sommaire:

Il s’agit d’une étude de phase 2 portant sur l’association des médicaments olaparib et durvalumab pour le traitement des tumeurs solides mutées par l’isocitrate déshydrogénase (IDH). L’objectif de cette étude est d’évaluer l’efficacité de l’association de médicaments par l’entremise du taux de réponse global et du taux de maîtrise global de la maladie. On pense qu’il serait plus utile d’administrer l’olaparib et le durvalumab ensemble à des patients atteints de tumeurs solides mutées par l’IDH que de donner chaque médicament seul.

Description de l'essai

Primary Outcome:

• Overall response rate
• Overall disease control rate

Secondary Outcome:

• Progression-free survival
• Overall survival
• Number of incidences of adverse events

Patients with documented IDH mutations will be screened for eligibility within 4 weeks of the start of study treatment including medical history, physical exam, height, weight, vital signs, performance status, routine blood lab tests, pregnancy test, ECG, and tumour measurements for safety, and research blood and archival tumour tissue collection for biomarker research. In the event participants require surgery or biopsy during their participation in the study, samples of the tumour tissue removed will be collected for biomarker research. Eligible participants will be assigned to a cohort depending on their type of cancer:

• Cohort A: IDH-mutated glioma (a type of brain/spinal cord cancer)

• Cohort B: IDH-mutated cholangiocarcinoma (a type of bile duct cancer)

• Cohort C: All other IDH-mutated solid tumours While on the study drugs, participants will have many of the screening tests and procedures repeated for safety and for biomarker research. If participants are permanently taken of the study drugs for any reason, they will be asked to return to the clinic about 4 weeks after the last dose of study drugs to have tests and procedures done during the study repeated for safety and research purposes. After the End of Study Drug visit, participants will continue to be followed-up by telephone or by clinic visit every 8-12 weeks until they no longer wish to be followed or they start a new anti-cancer treatment, or until 1 year after your last dose of study drugs.

Voir cet essai sur ClinicalTrials.gov