DONATE TODAY
To Increase Patient Access
End Brain Cancer Mobile App to download your number one tool for navigating this disease.

Servier Pharmaceuticals is a privately held company focused on oncology. Everything we do is to bring the promise of tomorrow to the patients we serve.

Driven by discovery in oncology and potentially other areas of unmet medical need, we leverage Servier Group’s global portfolio and seek acquisitions, licensing deals and partnerships. We are poised to be an innovative leader serving U.S. patients and caregivers.
LEARN MORE ABOUT SERVIER

Current Study Overview

"Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Astrocytomas"

The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be evaluated following pre-surgical treatment with vorasidenib and pembrolizumab combination, compared to untreated control tumors. Prior to surgery, participants will be randomized to receive vorasidenib
at the RCD in combination with pembrolizumab, or vorasidenib only, or no treatment (untreated control group). Following surgery, participants will have the option to receive treatment with vorasidenib in combination with pembrolizumab in 21-day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. (NCT Number: NCT05484622)
LEARN MORE ABOUT THIS CLINICAL TRIAL

Participation Criteria

INCLUSION CRITERIA

  1. Have Karnofsky Performance Status (KPS) of ≥ 70%.
  2. Have expected survival of ≥ 3 months.
  3. Have histologically confirmed Grade 2 or Grade 3 astrocytoma (per the 2016 World Health Organization [WHO] Classification of Tumors of the central nervous system)
  4. Have documented IDH1-R132H gene mutation and absence of 1p19q co-deletion (i.e., non-co-deleted, or intact) by local testing.
  5. Have measurable, magnetic resonance imaging (MRI)-evaluable, unequivocal contrast enhancing disease as determined by institution radiologist/Investigator at Screening on either 2D T1 post-contrast weighted images or 3D T1 post-contrast weighted images. Per mRANO criteria, measurable lesion is defined as at least 1 enhancing lesion measuring ≥ 1 cm x ≥ 1 cm.
  6. Have recurrent or progressive disease and received prior treatment with chemotherapy, radiation, or both.
  7. Surgical resection is indicated for treatment, but surgery is not urgently indicated (e.g., for whom surgery within the next 6-9 weeks is appropriate). (NOTE: This criterion only applies to participants enrolled in the perioperative phase of the study. Participants in the Safety Lead-In should not require surgery).

EXCLUSION CRITERIA

  1. Have received prior systemic anti-cancer therapy within 1 month of the first dose of IMP, radiation within 12 months of the first dose of IMP, or an investigational agent < 14 days prior to the first dose of IMP. In addition, the first dose of IMP should not occur before a period of ≥ 5 half-lives of the investigational agent has elapsed.
  2. Have received 2 or more courses of radiation.
  3. Have received any prior treatment with an isocitrate dehydrogenase (IDH) inhibitor; anti-programmed cell death 1 (PD1), anti-programmed cell death ligand 1 (PD-L1), or anti-PD-ligand 2 (L2) agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137); any other checkpoint inhibitor; bevacizumab; or any prior vaccine therapy.

 

 

 

Note: Other inclusion and exclusion criteria may apply.

Site Locations

Recruiting - (R); Non Recruiting - (NR)

California
University of California, Los Angeles (NR)

University of California, San Francisco (NR)
Florida
University of Miami (R)

Illinois
Northwestern University (NR)
Massachusetts
Massachusetts General Hospital (NR)
Dana-Farber Cancer Institute (NR)
New York
Memorial Sloan Kettering Cancer Center (R)
North Carolina
Duke University (NR)
Texas
MD Anderson Cancer Center (NR)

CONTACT INFORMATION

Institut de Recherches Internationales 
Servier Clinical Studies Department 
+33 1 55 72 43 66 
scientificinformation@servier.com

*Please use the trial identifier NCT Number NCT05484622 in all correspondence.

ENDBRAINCANCER INITIATIVE | CHRIS ELLIOTT FUND

Enhancing patient outcomes by expanding FDA-approved treatment modalities and fueling research in the pharma/bio/life sciences, device & diagnostic industries and by closing the existing GAP from initial diagnosis to IMMEDIATE AND EXPANDED ACCESS to specialists, researchers, advanced & innovative treatments, clinical trials and critical care with the ultimate goal of improving patient outcomes through updating and improving WHO & NCCN Guidelines and clinical practices related to Standard of Care for brain cancer patients.

TAX ID:26-2185614
DONATE
corporate partners
upcoming events
resources
About us
envelopephonemap-markerpointer-right
linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram