← Back to Search

Checkpoint Inhibitor

Nivolumab +/− Stereotactic Radiosurgery for Chordoma

Phase 1

Waitlist Available

Led By Lawrence Kleinberg, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cross-sectional imaging evidence of progression of recurrent or metastatic disease

Karnofsky performance scale >= 70%

Must not have

Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Unable to meet radiation treatment plan parameters

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks after initial dose of nivolumab

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying nivolumab with or without SRS to treat patients with chordoma. Nivolumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. SRS is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation in various organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid dysfunction), liver issues; SRS might lead to localized skin redness/swelling at the radiation site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My scans show my cancer has grown or spread.

Select...

I am able to care for myself but may not be able to do active work.

Select...

My cancer, chordoma, has been confirmed by a tissue sample.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have received high-dose radiation treatment.

Select...

I haven't taken experimental drugs within the last 21 days or 5 half-lives.

Select...

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Select...

I have been diagnosed with HIV.

Select...

I do not have an active infection needing treatment, including hepatitis B or C.

Select...

I haven't had chemotherapy in the last 3 weeks.

Select...

I have or had an autoimmune disease or needed medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks after initial dose of nivolumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks after initial dose of nivolumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks after initial dose of nivolumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Stereotactic Radiosurgery

2021

Completed Phase 2

~440