Nivolumab +/− Stereotactic Radiosurgery for Chordoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byLawrence Kleinberg, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

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.

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

My scans show my cancer has grown or spread.

I can provide details of my past cancer treatments and when my cancer progressed.

My kidney function tests are normal.

+12 more

Exclusion Criteria

I have been cancer-free for at least 2 years, except for certain cancers.

I haven't taken steroids or immunosuppressants in the last 14 days.

My condition doesn't allow for the planned radiation treatment.

+14 more

Participant Groups

The trial is testing the safety of nivolumab (a monoclonal antibody) alone or combined with stereotactic radiosurgery (SRS), a precise high-dose radiation treatment targeting tumors with minimal damage to surrounding tissue. The goal is to see which approach better inhibits tumor growth in recurrent or metastatic chordoma.

2Treatment groups

Experimental Treatment

Group I: Arm II (nivolumab, SRS)Experimental Treatment3 Interventions

Patients receive nivolumab as in Arm I. Patients undergo stereotactic radiosurgery (SRS) as per standard of care on day 8 of course 1.

Group II: Arm I (nivolumab)Experimental Treatment2 Interventions

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 14 days for 8 doses, then every 28 days for a total of 2 years in the absence of disease progression or unacceptable toxicity.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: