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Drug duo targets Hard-to-Treat IDH-Mutated tumors

NCT ID NCT03991832

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.