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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 below
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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 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

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
~460

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,479 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
557 Previous Clinical Trials
32,879 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02989636 — Phase 1
Chordoma Research Study Groups: Arm I (nivolumab), Arm II (nivolumab, SRS)
Chordoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02989636 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02989636 — Phase 1
Chordoma Patient Testimony for trial: Trial Name: NCT02989636 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental trial unique in its approach?

"The research into nivolumab began in 2012 when Ono Pharmaceutical Co. Ltd completed their initial trial, which included 659 participants. Based on the results of this first study and subsequent Phase 1 & 2 drug approvals, there are now 717 active studies concerning this medication occurring across 2356 cities and 49 countries worldwide."

Answered by AI

What earlier studies have explored the effects of Nivolumab?

"At present, there are 82 Phase 3 trials investigating Nivolumab and 717 live clinical studies overall. While Bern, BE is one of the locations for these experiments, globally there are 40290 sites running research on this drug."

Answered by AI

Does Nivolumab have the necessary regulatory approval for medical usage?

"Due to the limited safety and efficacy data, our Power team has concluded that Nivolumab carries a risk rating of 1."

Answered by AI

Are any opportunities for enrolment into this trial still available?

"Clinicaltrials.gov confirms that the current recruitment period for this medical study has expired. Starting on March 10th, 2017 and ending October 3rd 2022, no further candidates are being sought out presently. However, there are 743 other clinical trials currently enrolling patients at this time."

Answered by AI

What medical ailments does Nivolumab address?

"Nivolumab is a widely used therapeutic for malignant tumours. It has been clinically proven to treat several conditions including inoperable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How many participants are currently engaged in this clinical experiment?

"This study is no longer accepting applications, having been first posted on 10th March 2017 and most recently updated on 3rd October 2022. Nevertheless, there are 26 trials for chordoma that have open enrolment periods and 717 studies requiring participants to utilise Nivolumab as a treatment option."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have tried surgery and radiation but not responded , I hope your staff can help me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients With Recurrent, Advanced, or Metastatic Chordoma
2017. "Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients With Recurrent, Advanced, or Metastatic Chordoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02989636.
All > Sbrt > Chordoma
~1 spots leftby Nov 2024
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