Drug duo targets Hard-to-Treat IDH-Mutated tumors
NCT ID NCT03991832
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether combining two drugs—olaparib and durvalumab—can shrink or control solid tumors that have an IDH mutation. The study includes adults with certain brain tumors (glioma) or bile duct cancer (cholangiocarcinoma) that have not responded well to prior therapy. Olaparib blocks a protein that helps cancer cells grow, while durvalumab helps the immune system attack cancer cells. The goal is to see if the pair works better than either drug alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olaparib and durvalumab
- What this could lead to
- If successful, this drug combination could offer a new treatment option for people with IDH-mutated cancers, potentially slowing tumor growth or shrinking tumors.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply to everyone. The combination may cause side effects or fail to work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Must be ≥ 18 years. * Body weight \> 30 kg. * For Cohort A: Patients must have histologically or cytologically confirmed diffuse astrocytic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant. They must have not received more than 2 regimens of systemic therapy after initial relapse. * For Cohort B: Patients must have histologically or cytologically confirmed adenocarcinoma of the biliary tract which are IDH mutant. They must have not received more than 2 regimens of systemic therapy for advanced disease. * Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Patients must have a life expectancy ≥ 16 weeks. * All participants must agree to use methods to prevent pregnancy as agreed upon between the participant and the study doctor from the signing of the informed consent form and continue throughout the period of taking study treatments and for 3 months after the last doses of study drugs. * Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. * Patients in Cohorts A and B must have measurable disease * Patients with glioma or central nervous system (CNS) metastases must be asymptomatic and at least 28 days after the most recent CNS treatment and is clinically stable, and at least 14 days on stable doses of corticosteroids and/or anti-seizure medications. Exclusion Criteria: * Involvement in the planning and/or conduct of the study. * Concurrent enrolment in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an interventional study. * Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the planned first dose of olaparib and durvalumab. * Any previous treatment with PARP inhibitor or PD-1/PD-L1 inhibitors including olaparib and durvalumab. * Other malignancy within the last 5 years with exceptions. * Resting ECG with QTc \> 470 msec or family history of long QT syndrome. * Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 4 weeks prior to planned start of study treatment. * Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. This criterion does not apply to patients in Cohort A. * Persistent toxicities caused by previous cancer therapy, excluding alopecia and laboratory values listed per the inclusion criteria. * Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML. * Patients with symptomatic uncontrolled brain metastases. * Major surgery within 2 weeks of starting study treatment. Patients must have recovered from any effects of any major surgery to be considered eligible. * Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of olaparib. * Female patients who are pregnant, lactating, or intend to become pregnant during their participation in this study. * Immunocompromised patients. * Patients with a known hypersensitivity to olaparib or durvalumab or any of the excipients of the products. * Patients with known active hepatitis (i.e. Hepatitis B or C). * Patients requiring whole blood transfusions in the last 120 days prior to entry to the study. * Current or prior use of immunosuppressive medications within 14 days before the 1st dose with exceptions. * Active or prior documented autoimmune or inflammatory disorders within the last 2 years. * History of allogenic organ transplantation. * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational products or interpretation of patient safety or study results. * Prior enrolment in this study. * Receipt of liver attenuated vaccines within 30 days prior to the 1st dose of investigational products, during the study and 30 days after the last dose of study treatments. * Known active infection including tuberculosis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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