CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 58 target
Drug / intervention
Olaparib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 11
  • ✓Age ≥18 years
  • ✓Body weight >30 kg
  • ✓Cohort A: IDH-mutant diffuse astrocytic/oligodendroglial tumors (WHO 2016) with ≤2 prior systemic regimens after relapse
  • ✓Cohort B: IDH-mutant biliary tract adenocarcinoma with ≤2 prior systemic regimens for advanced disease
Key exclusion· 23
  • ✕Concurrent enrollment in another clinical study (except observational or follow-up studies)
  • ✕Any anticancer therapy within 4 weeks prior to first olaparib/durvalumab dose
  • ✕Prior PARP inhibitor or PD-1/PD-L1 inhibitor treatment
  • ✕Other malignancy within last 5 years (with exceptions)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03991832
NCT03991832Phase 2ActiveOn Track
CompareCT.gov

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

University Health Network, Toronto·interventional·Posted Jun 19, 2019·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Olaparib and Durvalumab for Glioma and 3 related conditions. Active but no longer recruiting, targeting 58 participants across 1 site.

Detailed Summary

This is a phase 2 study of the combination of drugs olaparib and durvalumab for the treatment of isocitrate dehydrogenase or (IDH) mutated solid tumors. The purpose of this study is to assess the efficacy of the drug combination via overall response rate and overall disease control rate. It is believed that giving olaparib and durvalumab together would be more useful when given to patients with IDH-mutated solid tumors than giving each drug alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma, Cholangiocarcinoma, Solid Tumor, IDH Mutation
CountriesCanada
Collaborators--

Timeline

Phase 2Active
2020202120222023202420252026
First PostedJun 19, 2019
Enrollment StartDec 31, 2019
Primary CompletionSep 30, 2026
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 7.0 years agoPrimary completion in 3 months

Arms & Interventions

Cohort A: IDH mutated gliomaexperimental

Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.

Drug: OlaparibDrug: Durvalumab
Cohort B: IDH mutated cholangiocarcinomaexperimental

Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.

Drug: OlaparibDrug: Durvalumab

Interventions

Olaparibdrug

Olaparib is a drug that blocks a protein called poly (ADP-ribose) polymerase (PARP). PARP is important in the growth and spread of cancer cells. Because of this, blocking PARP from working is expected to stop the growth of or shrink cancer cells.

Durvalumabdrug

Durvalumab is a drug that works by stopping a protein called Programmed Cell Death Ligand 1 (PD-L1) from working. PD-L1 is a protein that is thought to prevent the immune system (the body's defense against diseases) from killing cancer cells. Stopping PD-L1 from working is expected to allow the immune system to once again prevent or slow down cancer growth.