Olaparib and Durvalumab (MEDI4736) in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT05659914
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib+durvalumab — DRUG
    olaparib: 300 mg tablets taken orally twice daily and durvalumab: 1500 mg via IV infusion q4w

Study Details

Patients with metastatic pancreatic cancer and germline mutation in BRCA have benefit of therapy with PARP inhibitors. In addition, some studies have demonstrated that PDL-1 inhibitors synergize therapeutically with PARP inhibitors in tumours with homologous repair deficiency. Our hypothesis is that those patients with alterations in DNA damage repair genes (somatic and germline BRCA1, BRCA2, PALB2, RAD51C, RAD51D and other functional DDR genes) and who have benefit from platinum based therapy in first line might obtain an increased therapeutic effect with the combination of olaparib and durvalumab. This is an open-label, single-arm, multicentric phase II clinical trial of a combination of durvalumab and olaparib in patients with metastatic pancreatic cancer with alterations in DDR genes, who have had benefit with platinum-based chemotherapy in first line setting. The primary objective is to investigate the efficacy of this combination in terms of ORR. Patients will be eligible for the study based on alterations in a panel of specific DDR genes including BRCA1, BRCA2, PALB2, RAD51C, RAD51D and other DDR genes, as determined by a local assay according to local practice or by the central laboratory (if local assay is not available).

Key Dates

Start date
Nov 28, 2022
Status verified
Oct 2024
Primary completion
Dec 1, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib +durvalumab
    olaparib+durvalumab

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Baseline through the end of the study (up 42 months) ]

Related Studies