Immune Checkpoint Inhibitor Nivolumab in People With Select Rare CNS Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03173950|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : February 18, 2020
More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.
To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.
Adults whose rare CNS tumor has returned.
Participants will be screened:
- Heart and blood tests
- Physical and neurological exam
- Hepatitis tests
- Pregnancy test
- MRI. They will lay in a machine that takes pictures.
- Tumor tissue sample. This can be from a previous procedure.
At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.
Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.
Participants will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.
Genetic tests will be done on participants' tumor tissue. Participants will be contacted if any clinically important results are found.
After treatment ends, participants will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....
|Condition or disease||Intervention/treatment||Phase|
|Medulloblastoma Ependymoma Pineal RegionTumors Choroid Plexus Tumors Atypical/Malignant Meningioma Histone Mutated Glioma Gliomatosis Cerebri Atypical Teratoid Rhabdoid Tumor (ATRT) Gliosarcoma/Primary Brain Sarcoma||Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients With Select Rare CNS Cancers|
|Actual Study Start Date :||July 13, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: 1/Experimental Therapy
Participants will receive nivolumab at standard dose of240mg IV every 2 weeks for cycles 1 through 2, thendoses of 480mg every 4 weeks for a total of 14 additional doses
Participants will receive nivolumab at standard dose of 240mg IV every 2 weeks for cycles 1 through 2, then doses of 480mg every 4 weeks for a total of 14 additional doses
- objective response [ Time Frame: end of treatment ]Rate of achieving a confirmed Complete Response/Partial Response (confirmed by imaging one month later)
- progression free survival rate [ Time Frame: 6 months after end of treatment ]Rate of durable Stable Disease lasting at least 6 months (PFS-6)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173950
|Contact: Kathleen Wall (Mendoza)||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Marta Penas-Prado, M.D.||National Cancer Institute (NCI)|