NCT05659914

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

Active, enrolled Phase 2 Last updated 18 October 2024

What this trial tests

Phase 2 trial testing olaparib+durvalumab in Metastatic Pancreatic Cancer in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 November 2022

Primary endpoint
1 December 2025

1 June 2026

Quick facts

Lead sponsor	Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	28 November 2022
Primary completion	1 December 2025
Estimated completion	1 June 2026
Sites	3 locations across Spain

Drugs / interventions tested

• olaparib+durvalumab — full drug profile →

Conditions studied

• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Who can join

18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Germline BRCA testing in pancreatic cancer: improving awareness, timing, turnaround, and uptake.
   Golan T, Casolino R, Biankin AV, Hammel P, et al · · 2023 · cited 10× · PMID 37720496 · DOI 10.1177/17588359231189127
2. Unleashing the Power of Synthetic Lethality: Augmenting Treatment Efficacy through Synergistic Integration with Chemotherapy Drugs.
   Du Y, Luo L, Xu X, Yang X, et al · · 2023 · cited 8× · PMID 37896193 · DOI 10.3390/pharmaceutics15102433
3. Clinical Evaluation of the Pancreatic Cancer Microenvironment: Opportunities and Challenges.
   Szczepanski JM, Rudolf MA, Shi J. · · 2024 · cited 7× · PMID 38398185 · DOI 10.3390/cancers16040794
4. Detection and therapeutic implications of homologous recombination repair deficiency in pancreatic cancer: a narrative review.
   Tan H, Hosein PJ. · · 2023 · cited 5× · PMID 37969835 · DOI 10.21037/jgo-23-85
5. The distinct landscape of tumor immune microenvironment in homologous recombination deficient cancers.
   Xu Q, Wen Y, Huang T, Li H, et al · · 2025 · cited 1× · PMID 40830526 · DOI 10.1186/s40364-025-00814-x
6. Molecular insights into immune evasion and therapeutic paradigms in pancreatic cancer.
   Li M, Zhou R, Qiu Y, Peng Y, et al · · 2025 · cited 1× · PMID 40642496 · DOI 10.21147/j.issn.1000-9604.2025.03.13