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PD-1 Inhibitor
Vorasidenib + Pembrolizumab for Brain Cancer
Phase 1
Recruiting
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 55 months
Awards & highlights
Study Summary
This trialtests combining two drugs to treat advanced brain cancer with a gene mutation.
Who is the study for?
This trial is for adults with Grade 2 or 3 astrocytoma brain tumors that have an IDH-1 mutation and no co-deletion of chromosomes 1p/19q. Participants must have had prior treatment, be in good physical condition (KPS ≥70%), and not need immediate surgery. They can't join if they've had certain recent treatments, multiple radiation therapies, or used drugs targeting similar cancer pathways.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Vorasidenib and Pembrolizumab in patients with recurrent or progressive astrocytomas. It aims to see how well these drugs work together against this type of brain tumor that has come back or worsened after initial treatment.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, skin rashes, fatigue, liver problems, hormonal gland issues like thyroid dysfunction, and potential complications from the body's response to the drug infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 55 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 55 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Tumor-infiltrating Lymphocyte (TIL) Cells in Surgically Resected Tumors Following Treatment With Vorasidenib + Pembrolizumab Compared to Untreated Control Tumors
Safety Lead-in Phase: Percentage of Participants With Dose-limiting Toxicities (DLTs)
Secondary outcome measures
AUC: Area Under the Plasma Concentration-Time Curve of Vorasidenib
Clinical Activity Associated With Vorasidenib in Combination With Pembrolizumab According to Modified Response Assessment in Neuro-oncology (mRANO) Criteria
Cmax: Maximum Observed Plasma Concentration of Vorasidenib
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Safety Lead-In Phase: Vorasidenib + PembrolizumabExperimental Treatment2 Interventions
Participants will receive vorasidenib orally, once daily (QD) in combination with pembrolizumab 200 mg intravenous (IV) infusion, once every 3 weeks (Q3W) in each 21-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Group II: Randomized Perioperative Phase: Vorasidenib OnlyExperimental Treatment1 Intervention
Participants will receive vorasidenib orally, QD from Day 1 to 28 of a 28-day cycle prior to surgery.
Group III: Randomized Perioperative Phase: Vorasidenib + PembrolizumabExperimental Treatment2 Interventions
Participants will receive vorasidenib recommended combination dose (RCD) determined in the Safety Lead-in phase, orally, QD from Day 1 to 28 in combination with pembrolizumab 200 mg IV infusion, Q3W on Days 1 and 22 of a 28-day cycle prior to surgery.
Group IV: Randomized Perioperative Phase: Untreated Control GroupActive Control1 Intervention
Participants will not receive any treatment prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorasidenib
2023
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
67,064 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,011 Total Patients Enrolled
7 Trials studying Astrocytoma
2,881 Patients Enrolled for Astrocytoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been treated with specific cancer drugs like IDH inhibitors or immunotherapies.My tumor has an IDH1 mutation but no 1p19q co-deletion, or it has lost ATRX or has an ATRX mutation.I haven't had cancer treatment or investigational drugs too close to starting the trial.I am able to care for myself and perform normal activities with minimal assistance.I have undergone at least 2 radiation therapy sessions.My MRI shows a clear tumor that is at least 1cm big.I need surgery for my condition, but it's not urgent and can wait 6-9 weeks.My cancer came back or got worse after treatment with chemotherapy or radiation.My astrocytoma is confirmed as Grade 2 or 3 by WHO standards.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Perioperative Phase: Vorasidenib + Pembrolizumab
- Group 2: Randomized Perioperative Phase: Untreated Control Group
- Group 3: Randomized Perioperative Phase: Vorasidenib Only
- Group 4: Safety Lead-In Phase: Vorasidenib + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the geographical reach of this trial?
"This investigation is currently taking place in 9 distinct locations, including Durham, Boston and Miami. To reduce the amount of travelling necessary to participate, it would be prudent for interested parties to select a nearby site."
Answered by AI
How detrimental can the implementation of Vorasidenib be for patients?
"Our team evaluated the safety of Vorasidenib at a level 1 due to the limited data backing its efficacy and safety, as this is only in Phase 1 testing."
Answered by AI
How many participants can this research investigation accommodate?
"This clinical trial necessitates the recruitment of 72 participants that meet the outlined inclusion criteria. Potential enrollees can be found at Duke University in Durham, North carolina or Massachusetts General Hospital in Boston, Massachusetts."
Answered by AI
Does this trial currently accept participants?
"Indeed, the clinicaltrials.gov platform indicates that this medical experiment is presently recruiting participants. The trial was first published on November 30th 2022 and had its latest update on November 10th 2022; it requires 72 volunteers to be recruited from 9 sites."
Answered by AI
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