Clinical Trials Logo

Clinical Trial Summary

This research trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma. The names of the study drugs involved in this study are: - Nivolumab - Ipilimumab - Placebo (IV solution with no medicine) - Zr-89 Crefmirlimab berdoxam (optional sub-study)


Clinical Trial Description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 60 people will take part in this research study. There are 3 study groups participating in this study and each group receives different study drugs. After screening, participants will be randomized into one of three study groups. Participants will receive one of the following study treatments prior to undergoing surgery for tumor removal: - Group A receives nivolumab plus ipilimumab - Group B receives nivolumab plus placebo-ipilimumab - Group C receives two placebo infusions, placebo-nivolumab plus placebo-ipilimumab Neither the participant nor the research doctor will know which study drugs the participant will receive prior to surgery. After recovering from surgery, participants will receive the following doses of study medication: -- Nivolumab plus ipilimumab every 3 weeks for 3 doses followed by nivolumab every 4 weeks This research study is a Phase Ib clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved the use of nivolumab or ipilimumab for your specific disease, but it has been approved for other uses. Both nivolumab and ipilimumab are antibodies (types of human protein) that work to stop tumor cells from growing and multiplying by immunotherapy. Immunotherapy is trying to have the body's own immune system work against tumor cells. Nivolumab and ipilimumab have been used in other research studies, and information from those other research studies suggest these drugs may help to stop glioblastoma cells from growing. Subjects also have the option of undergoing Zr-89 Crefmirlimab berdoxam PET scans. This consists of one infusion with Zr-89 Crefmirlimab berdoxam followed by a PET scan prior to starting study treatment and another infusion with PET scan about 3 days prior to surgery. The U.S. Food and Drug Administration (FDA) has not approved Zr-89 Crefmirlimab berdoxam as a treatment for any disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04606316
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 1, 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05664243 - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Recruiting NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT03679754 - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Terminated NCT03927222 - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Phase 2
Recruiting NCT03897491 - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma Phase 2
Active, not recruiting NCT03587038 - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma Phase 1
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT04391062 - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma Phase 2
Active, not recruiting NCT03661723 - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Phase 2
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Completed NCT02206230 - Trial of Hypofractionated Radiation Therapy for Glioblastoma Phase 2
Completed NCT03493932 - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT03018288 - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) Phase 2
Withdrawn NCT03980249 - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells Early Phase 1
Not yet recruiting NCT04552977 - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma Phase 2
Withdrawn NCT02876003 - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma Phase 2