Nivolumab +/− Stereotactic Radiosurgery for Chordoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or investigational drugs within 21 days before starting the trial, and you should not be on systemic steroids or immunosuppressive medications within 14 days of starting the study drug.
What data supports the effectiveness of the treatment Nivolumab +/− Stereotactic Radiosurgery for Chordoma?
Research suggests that chordoma may respond to immunotherapy, as seen in cases where patients with advanced chordoma showed positive responses to anti-PD1 antibodies, similar to Nivolumab. Additionally, stereotactic radiosurgery has been used to improve local control in various cancers, which may also benefit chordoma treatment.12345
Is the combination of Nivolumab and Stereotactic Radiosurgery safe for humans?
How does the drug Nivolumab differ from other treatments for chordoma?
Nivolumab is unique for chordoma treatment because it is an immunotherapy drug that works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. This approach is different from traditional treatments like surgery and radiation, and it may offer a new option for patients whose tumors are resistant to conventional therapies.12348
What is the purpose of this trial?
This phase I trial studies the side effects of nivolumab with or without stereotactic radiosurgery (SRS) in treating patients with chordoma that has come back or spread from where it started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab with or without stereotactic radiosurgery may work better in treating patients with chordoma.
Research Team
Lawrence Kleinberg, MD
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Eligibility Criteria
This trial is for adults with chordoma that has returned or spread, who can perform most daily activities (Karnofsky score >= 70%). They must have measurable disease progression and adequate organ function. Women of childbearing potential and sexually active men must use contraception. Exclusions include prior anti-PD-1/PD-L1 therapy, recent vaccines, certain previous treatments, active infections including HIV/hepatitis B/C, autoimmune diseases requiring steroids or immunosuppressants, pregnancy/breastfeeding, and inability to follow up.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab intravenously every 14 days for 8 doses, then every 28 days for a total of 2 years. In Arm II, patients also undergo stereotactic radiosurgery on day 8 of course 1.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 100 days and every 10 weeks thereafter.
Treatment Details
Interventions
- Nivolumab
- Stereotactic Radiosurgery
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Chordoma Foundation
Collaborator
National Cancer Institute (NCI)
Collaborator