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Checkpoint Inhibitor

Nivolumab + Radiosurgery for Brain Cancer

Phase 2
Waitlist Available
Led By Philip Wong, MD, FRCPC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether the combination of Nivolumab and SRS can help control cancer progression and improve patient survival.

Who is the study for?
This trial is for adults (18+) with stage IV lung cancer, melanoma, or renal cell carcinoma who have brain metastases. They should be relatively healthy (ECOG 0-1), able to consent, complete tests and questionnaires, and not have had more than three prior systemic treatments. Excluded are those on recent steroids/immunosuppressants, with certain autoimmune diseases or seizures, drug contraindications, other cancers besides specified ones, hazardous conditions for Nivolumab use or previous specific treatments.Check my eligibility
What is being tested?
The study investigates combining Stereotactic radiosurgery (SRS) with an immune system modulator called Nivolumab in patients with brain metastases from certain cancers. The goal is to see if this combination can better control cancer progression compared to what's currently available.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs like the lungs or intestines; skin issues; hormone gland problems; kidney dysfunction; infusion reactions; fatigue and weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intracranial progression-free survival
Secondary outcome measures
Acute and late toxicity of SRS + Nivolumab
Correlation between tumor PD-L1 expression and clinical outcomes
Imaging indicators of response
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiosurgery and NivolumabExperimental Treatment2 Interventions
Interventions: Nivolumab (240mg IV q2week or 480mg IV q4week) and Radiosurgery (15-20 Gray (Gy) in 1 fraction) Upon entering this trial, patients with metastatic brain disease(s) will receive Nivolumab. One to 2 week after receiving the first dose of Nivolumab, radiosurgery will be delivered at doses ranging from 15 to 20 Gy in 1 fraction to the brain metastases to a maximum volume of 10 cubic centimeter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Radiosurgery
2005
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,611 Total Patients Enrolled
2 Trials studying Melanoma
90 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,474 Total Patients Enrolled
177 Trials studying Melanoma
57,517 Patients Enrolled for Melanoma
Philip Wong, MD, FRCPCPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02978404 — Phase 2
Melanoma Research Study Groups: Radiosurgery and Nivolumab
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02978404 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02978404 — Phase 2

Frequently Asked Questions

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

Has a similar clinical trial ever been conducted before?

"Radiosurgery was first explored in 2012, when Ono Pharmaceutical Co. Ltd conducted their inaugural study of 659 patients. Subsequent Phase 1 & 2 trials were successful and Radiosurgery has since become a widely studied treatment method with 718 active investigations across 49 countries and 2354 cities."

Answered by AI

What previous research has been conducted regarding Radiosurgery?

"At present, there are 82 Phase 3 trials and a total of 718 active studies for Radiosurgery. The vast majority of these experiments occur in Zürich, BE; however, it is possible to find research sites conducting this type of study across over 40 thousand global locations."

Answered by AI

How many participants are partaking in this research investigation?

"This clinical trial has ended its recruitment period. Initially posted on June 2nd 2017, the study's last edit was on August 2nd 2022. For those looking for similar studies, there are currently 3697 trials searching for patients with carcinoma renal cell and 718 separate Radiosurgery investigations that remain open to participants."

Answered by AI

Are patients able to enrol in this trial at present?

"This particular study is no longer enrolling participants. Its initial posting was on June 2nd 2017, with the latest update made on August 2nd 2022. For those who are still looking for other trials to join, there are currently 3697 clinical studies involving carcinoma and renal cell cases that are actively recruiting as well as 718 treatments related to radiosurgery in need of patients."

Answered by AI

How detrimental is Radiosurgery to human wellbeing?

"Our team at Power assigned radiosurgery a score of 2 due to the presence of clinical data confirming its safety, despite the lack of evidence supporting efficacy."

Answered by AI

How is Radiosurgery commonly being employed to alleviate health problems?

"Radio-surgery can be utilized to manage malignant neoplasms, unmanageable melanoma, and squamous cell carcinoma."

Answered by AI
~3 spots leftby Apr 2025