Nivolumab for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms+5 More
Nivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding radiosurgery to immunotherapy treatment will improve response rates in patients with metastatic breast cancer that has spread to the brain.

Eligible Conditions
  • Malignant Neoplasms
  • Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At 3, 6 and 12 months post treatment

Month 12
Evaluation of intracranial distant brain tumor following treatment
Brain
Up to 12 months
Extracranial Progression Free Survival (PFS)
Intracranial Progression Free Survival (PFS)
Up to 24 months
Overall Survival
Up to 8 weeks
Number of Participants who experience Dose Limiting Toxicities

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Nivolumab followed by stereotactic radiosurgery (SRS)
1 of 1
Experimental Treatment

14 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 1

Nivolumab followed by stereotactic radiosurgery (SRS)Experimental Group · 2 Interventions: Nivolumab, Stereotactic Radiosurgery · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Stereotactic Radiosurgery
2012
Completed Phase 2
~320

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3, 6 and 12 months post treatment

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
489 Previous Clinical Trials
123,356 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,582 Total Patients Enrolled
Kamran Ahmed, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
125 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.