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Home » Find Clinical Trials » Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

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Servier Protocol Code: CL1-95032-005 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05484622

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 17 locations

Study description

This study is needed to find better treatments for a type of brain cancer called glioma in people whose tumor may have come back after surgery (called recurrent) or is getting worse (called progressive) despite treatment.

In some gliomas, an abnormal (mutated) form of a protein called isocitrate dehydrogenase (IDH) is present in the tumor cells due to gene changes called mutations. This leads to the overproduction of 2 hydroxyglutarate (2-HG), a substance that is normally present in cells at low levels. Too much 2-HG impairs normal cell functioning and may cause some brain cells to become tumor cells.

Vorasidenib is a medicine that blocks the activity of abnormal IDH proteins. Vorasidenib may also increase the presence of immune cells in brain tumors. Pembrolizumab is another medicine that helps the immune system fight cancer.

Researchers believe that combining vorasidenib and pembrolizumab might help treat these recurrent/progressive tumors better compared to when these medicines are used alone.

The main goals of this study are:

  • To look at the safety and tolerability of vorasidenib in combination with pembrolizumab, and to find the best dose for this combination.
  • To see if the combination of vorasidenib and pembrolizumab increases the presence of CD3+ T-cells (a type of immune cell) in tumors compared with untreated tumors.
Official title: A Phase 1, Safety Lead-In and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination With Pembrolizumab in Subjects With Recurrent or Progressive IDH-1 Mutant Glioma
Protocol
English (USA)
Conditions
Astrocytoma Oligodendroglioma
Interventions / Treatments
  • Vorasidenib
  • Pembrolizumab
Other study id numbers
  • CL1-95032-005

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Have recurrent or progressive glioma with a documented IDH1 mutation.
  • Have previously received treatment with chemotherapy (treatment with medications directed towards their cancer), radiation, or both.
  • Have been recommended to undergo surgery as treatment of glioma for participants in Part 2.
  • Have adequate organ and bone marrow function.

Participants cannot take part in the study if they:

  • Had received treatment with anticancer medicines in the month before starting the study drug.
  • Had received treatment with radiation in the year before starting the study drug.
  • Have received two or more courses of radiation treatment.

How is the study designed?

Allocation
Randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Safety Lead-In Phase: Vorasidenib + Pembrolizumab

In Part 1, one cycle will last 21 days. Participants will receive vorasidenib daily and pembrolizumab on Day 1 of each cycle. These 21-day cycles will be repeated for as long as the cancer does not progress, and the participant does not have too severe side effects. The participant can also decide to stop the treatment at any time.

Intervention / Treatment
Drug: Vorasidenib

A tablet taken orally.

Drug: Pembrolizumab

Injected slowly into a vein (IV).

Participant Group / Arm
Experimental: Randomized Perioperative Phase: Vorasidenib + Pembrolizumab

In Part 2, one cycle will last 28 days. Participants will take vorasidenib daily for 28 days, including the day of their surgery. Some participants will also receive pembrolizumab, along with vorasidenib. Pembrolizumab will be given through a drip into a vein on Day 1 and Day 22 during this 28-day cycle.

Intervention / Treatment
Drug: Vorasidenib

A tablet taken orally.

Drug: Pembrolizumab

Injected slowly into a vein (IV).

Participant Group / Arm
Experimental: Randomized Perioperative Phase: Vorasidenib Only

Participants take vorasidenib orally once a day from Day 1 to Day 28 of a 28-day cycle before surgery.

Intervention / Treatment
Drug: Vorasidenib

A tablet taken orally.

Participant Group / Arm
No Intervention: Randomized Perioperative Phase: Untreated Control Group

Participants do not receive any treatment before surgery.

Intervention / Treatment

Keywords

Provided by Servier
Vorasidenib AG-881 Pembrolizumab IDH-1 Astrocytoma Oligodendroglioma Enchancing Non-enchancing
Additional Relevant MeSH Terms Glioma
Astrocytoma Oligodendroglioma