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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.
Patients in Cohorts A and B must have measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

SOLID Trial 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.Check my eligibility
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.See study design
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.

SOLID Trial 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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My disease can be measured or tracked.
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I am 18 years old or older.
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My organ and bone marrow functions are normal as tested within the last 28 days.
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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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I have a brain tumor or cancer spread to the brain, feel fine, and it's been 4 weeks since my last brain treatment.
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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.

SOLID Trial 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

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

SOLID 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
~2140
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,476 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this research?

"Clinical trials for Durvalumab began in 2005, with AstraZeneca as the primary sponsor. The first study only involved 98 patients but it was enough to get Phase 1 approval from the relevant drug authorities. Currently, 498 different studies are ongoing in 1844 cities and 65 countries around the world."

Answered by AI

Does Durvalumab have a history of being tested in other medical trials?

"498 studies are currently investigating Durvalumab with 74 of those in Phase 3. While a concentration of the research is based in Houston, Texas - there are actually 20,077 locations running clinical trials for Durvalumab."

Answered by AI

What are the most popular applications for Durvalumab?

"Durvalumab is a medication that can be given to patients for the treatment of disease. It is also effective in treating primary peritoneal cancer, pharmacotherapy, and advance directives."

Answered by AI

Are there any life-threatening risks associated with Durvalumab?

"Since this is a Phase 2 trial, there is only some data supporting the safety of Durvalumab. It received a score of 2."

Answered by AI

Is this research looking for more participants?

"That is correct. The clinical trial mentioned is looking for 78 individuals at present and the listing on clinicaltrials.gov reflects that it was first posted on December 31st, 2019 and edited most recently on November 29th, 2021."

Answered by AI

How many patients are participating in this clinical trial?

"Yes, that is correct. The information available on clinicaltrials.gov clearly demonstrates that this study is currently looking for participants. This particular trial was first posted on December 31st, 2019 and the most recent update was on November 29th, 2021. A total of 78 patients are needed across 1 site."

Answered by AI
~0 spots leftby Mar 2024