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GliomaPhase 2SOLIDNCT03991832

Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

A Phase 2 study testing Olaparib and Durvalumab in people with Glioma and Cholangiocarcinoma, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma, Cholangiocarcinoma, Solid Tumor
What is being tested?
Olaparib and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteCanada
Study dates
31 Dec 2019to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the detailed description

Patients with documented IDH mutations will be screened for eligibility within 4 weeks of the start of study treatment including medical history, physical exam, height, weight, vital signs, performance status, routine blood lab tests, pregnancy test, ECG, and tumor measurements for safety, and research blood and archival tumor tissue collection for biomarker research. In the event participants require surgery or biopsy during their participation in the study, samples of the tumor tissue removed will be collected for biomarker research.

Eligible participants will be assigned to a cohort depending on their type of cancer:

  • Cohort A: IDH-mutated glioma (a type of brain/spinal cord cancer)
  • Cohort B: IDH-mutated cholangiocarcinoma (a type of bile duct cancer)

While on the study drugs, participants will have many of the screening tests and procedures repeated for safety and for biomarker research.

If participants are permanently taken of the study drugs for any reason, they will be asked to return to the clinic about 4 weeks after the last dose of study drugs to have tests and procedures done during the study repeated for safety and research purposes.

After the End of Study Drug visit, participants will continue to be followed-up by telephone or by clinic visit every 8-12 weeks until they no longer wish to be followed or start a new anti-cancer treatment, or until 1 year after last dose of study drugs.

Being tested
Olaparib, Durvalumab
Medical subject headings
Glioma, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

    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

    Also called Imfinzi

    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.

Study groups in NCT03991832
Study groupRoleWhat they receive
Cohort A: IDH mutated gliomaExperimentalOlaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Receives: Drug: Olaparib; Drug: Durvalumab
Cohort B: IDH mutated cholangiocarcinomaExperimentalOlaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Receives: Drug: Olaparib; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    overall + partial response

    Measured: 3 years

  2. Overall disease control rate

    for both cohorts

    Measured: 3 years

Secondary outcomes (3)

  1. Progression-free survival

    For duration of study

    Measured: 3 years

  2. Overall survival

    for duration of study

    Measured: 3 years

  3. Number of incidences of adverse events

    for duration of study

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start31 Dec 2019
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03991832
Sponsor's protocol ID
19-5526
Other IDs
SOLID
Acronym
SOLID
Status last verified
Jun 2026
First submitted
18 Jun 2019
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib and Durvalumab in people with Glioma and Cholangiocarcinoma, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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