Nivolumab +/− Stereotactic Radiosurgery for Chordoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the drug nivolumab (Opdivo), with or without stereotactic radiosurgery (SRS), affects individuals with chordoma, a rare bone cancer that has returned or spread. The goal is to determine whether the combination or the drug alone more effectively stops cancer cells from growing and spreading. Individuals with recurrent or metastatic chordoma, showing noticeable growth, might be suitable for the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nivolumab is generally well-tolerated by patients. In one study involving nine chordoma patients, no serious side effects occurred. Some patients even experienced positive outcomes, with their tumors either shrinking or remaining stable.
Combining nivolumab with a precise type of radiation treatment called stereotactic radiosurgery (SRS) also appears safe. A study on patients with cancer that had spread to the brain found that adding SRS to nivolumab did not cause major side effects. This suggests the combination might be safe for treating chordoma, although more research is needed.
Overall, early trials indicate that these treatments are manageable for patients, with no unexpected safety issues reported so far.12345Why are researchers excited about this trial's treatments?
Researchers are excited about nivolumab for chordoma because it offers a new way to harness the body's immune system. Unlike traditional treatments like surgery and radiation, nivolumab is an immunotherapy drug that blocks the PD-1 protein on immune cells, potentially allowing them to better recognize and attack cancer cells. Additionally, in one of the treatment arms, nivolumab is paired with stereotactic radiosurgery (SRS), which precisely targets tumors with high-dose radiation, possibly enhancing the drug's effectiveness. This combination might offer a more targeted and less invasive option for patients, which could lead to more effective and personalized treatments for chordoma.
What evidence suggests that nivolumab with or without stereotactic radiosurgery could be effective for chordoma?
Research has shown that nivolumab, a treatment that aids the immune system in fighting cancer, may be effective for chordoma, a rare cancer. In this trial, some participants will receive nivolumab alone, while others will receive it combined with a precise radiation treatment called stereotactic radiosurgery (SRS). In some studies, patients with advanced chordoma benefited when nivolumab was used with another drug. For patients with cancer that had spread to the brain, combining nivolumab with SRS helped control brain tumors. These findings suggest that using nivolumab alone or with SRS might help manage chordoma by stopping the tumors from growing and spreading.12346
Who Is on the Research Team?
Lawrence Kleinberg, MD
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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