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PD-L1 Inhibitor

Olaparib + Durvalumab for Solid Tumors (SOLID Trial)

Phase 2
Recruiting
Led By Eric Chen, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must be ≥ 18 years.
Must not have
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Persistent toxicities caused by previous cancer therapy, excluding alopecia and laboratory values listed per the inclusion criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of a new combination of drugs to treat patients with IDH-mutated solid tumors.

Who is the study for?
Adults with IDH-mutated solid tumors, including specific brain and bile duct cancers, who have undergone limited prior treatments can join this trial. They must be in good physical condition (ECOG 0-1), not pregnant, willing to prevent pregnancy, and able to swallow pills. Participants should have a life expectancy of at least 16 weeks and stable health without recent major surgeries or uncontrolled medical issues.
What is being tested?
The study is testing the combination of two drugs: Olaparib and Durvalumab for treating IDH-mutated solid tumors. The goal is to see if taking these drugs together works better than when they're taken separately by measuring how well the cancer responds and how long patients' diseases are controlled.
What are the potential side effects?
Possible side effects include immune system reactions that could cause inflammation in various organs, fatigue, nausea, blood cell count changes which might increase infection risk or bleeding tendencies. There may also be allergic reactions related to either drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.
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My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.
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I am willing and able to follow the study's treatment and visit schedule.
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My body weight is over 30 kg.
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My disease can be measured or tracked.
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I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious, uncontrolled health issues or infections.
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I have lasting side effects from cancer treatment, but not hair loss or blood test issues.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I had major surgery over 2 weeks ago and have recovered from it.
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I have received an organ transplant from another person.
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I have had an autoimmune or inflammatory disorder in the past 2 years.
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My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I have brain metastases that are not under control and cause symptoms.
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I do not have any active infections, including tuberculosis.
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I have never been treated with PARP or PD-1/PD-L1 inhibitors like olaparib or durvalumab.
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I am not pregnant, breastfeeding, nor plan to become pregnant during the study.
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I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 4 weeks.
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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall disease control rate
Overall response rate
Secondary study objectives
Number of incidences of adverse events
Overall survival
Progression-free survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: IDH mutated cholangiocarcinomaExperimental Treatment2 Interventions
Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Group II: Cohort A: IDH mutated gliomaExperimental Treatment2 Interventions
Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Durvalumab
2017
Completed Phase 2
~3750

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,280 Total Patients Enrolled
Eric Chen, M.D.Principal InvestigatorPrincess Margaret Cancer Centre

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03991832 — Phase 2
Isocitrate Dehydrogenase Research Study Groups: Cohort A: IDH mutated glioma, Cohort B: IDH mutated cholangiocarcinoma
Isocitrate Dehydrogenase Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03991832 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03991832 — Phase 2
~4 spots leftby Mar 2025
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