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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Tumor-infiltrating Lymphocyte (TIL) Cells in Surgically Resected Tumors Following Treatment With Vorasidenib + Pembrolizumab Compared to Untreated Control Tumors

Secondary study objectives

Overall Survival (OS)

Time to response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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