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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks after initial dose of nivolumab
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My scans show my cancer has grown or spread.
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I am able to care for myself but may not be able to do active work.
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My cancer, chordoma, has been confirmed by a tissue sample.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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
2014
Completed Phase 3
~4750
Stereotactic Radiosurgery
2016
Completed Phase 2
~490
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,811 Total Patients Enrolled
4 Trials studying Chordoma
535 Patients Enrolled for Chordoma
Chordoma FoundationOTHER
2 Previous Clinical Trials
58 Total Patients Enrolled
2 Trials studying Chordoma
58 Patients Enrolled for Chordoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,078 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for at least 2 years, except for certain cancers.My scans show my cancer has grown or spread.I can provide details of my past cancer treatments and when my cancer progressed.I haven't taken steroids or immunosuppressants in the last 14 days.My condition doesn't allow for the planned radiation treatment.My kidney function tests are normal.I will use contraception for 7 months after my last dose if I am sexually active with a woman who can become pregnant.I have received high-dose radiation treatment.I haven't taken experimental drugs within the last 21 days or 5 half-lives.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been diagnosed with HIV.I do not have an active infection needing treatment, including hepatitis B or C.I am able to care for myself but may not be able to do active work.I am a man using contraception while on nivolumab.I haven't had radiation on my cancer spots in the last 6 months.I haven't had chemotherapy in the last 3 weeks.I haven't had any vaccines in the last 4 weeks.I have or had an autoimmune disease or needed medication to suppress my immune system.My cancer has spread to new areas outside of where it started.My cancer, chordoma, has been confirmed by a tissue sample.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab)
- Group 2: Arm II (nivolumab, SRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chordoma Patient Testimony for trial: Trial Name: NCT02989636 — Phase 1
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