NCT05093231

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

A Phase II Study Combining Pembrolizumab With Olaparib in Metastatic Pancreatic Adenocarcinoma (PDA) Patients With Mismatch Repair Deficiency or Tumour Mutation Burden > 4 Mutations/Mb

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden

Detailed description

This is a phase II single arm, open label, prospective trial investigating the efficacy of pembrolizumab plus olaparib in metastatic pancreatic adenocarcinoma patients exhibiting high tumour mutation burden (defined as ≥4 mutations/Mb, including tumours with Mismatch Repair Deficient (MMRD) /Microsatellite Instability (MSI) high).

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a highly selective immunoglobulin G4-kappa humanised monoclonal antibody against Programmed cell death protein 1 (PD-1) receptor. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype with the containing a stabilizing Serine 228 to Proline Fc mutation.
DRUG	Olaparib	Olaparib is a potent inhibitor of polyadenosine 5'diphosphoribose polymerase (PARP) developed as a monotherapy as well as for combination with chemotherapy, ionising radiation and other anti-cancer agents including novel agents and immunotherapy.

Timeline

• Start date: 2025-02-26
• Primary completion: 2027-07-31
• Completion: 2028-01-01
• First posted: 2021-10-26
• Last updated: 2025-09-18

Locations

13 sites across 1 country: United Kingdom