Spots Global Cancer Trial Database for Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Glioma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Glioma
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 Enhancing IDH-1 Mutant Glioma
Study ID: NCT05484622
Conditions
Study Description
Brief Summary: Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive enhancing isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Los Angeles (Site: 840113), Los Angeles, California, United States
University of California, San Francisco (Site: 840149), San Francisco, California, United States
University of Miami (Site: 840129), Miami, Florida, United States
Northwestern University (Site: 840123), Chicago, Illinois, United States
Massachusetts General Hospital (Site: 840104), Boston, Massachusetts, United States
Dana-Farber Cancer Institute (Site: 840139), Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center (Site: 840117), New York, New York, United States
Duke University (Site: 840110), Durham, North Carolina, United States
MD Anderson Cancer Center (Site: 840102), Houston, Texas, United States
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
