SBRT + Ipilimumab/Nivolumab for Carcinoma, Renal Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Renal Cell+2 More
SBRT + Ipilimumab/Nivolumab - Radiation
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effect of adding radiation therapy to the standard care treatment of immunotherapy drugs for metastatic kidney cancer.

Eligible Conditions
  • Carcinoma, Renal Cell
  • Metastatic Renal Cell Carcinoma ( mRCC)

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 years

1 Year
Subject safety
1 year
Correlation with blood or stool immune signatures
Exploratory Outcomes: Evaluation of baseline and changes during treatment in blood immune signatures
Exploratory Outcomes: Evaluation of baseline and changes during treatment in stool microbiome
Objective response rate
Quality of Life: EORTC QLQ-C30 questionnaire
2 years
Overall Survival
Progression free survival (PFS)
Year 1
Ipilimumab/ Nivolumab drug tolerability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Standard of Care I/N alone
1 of 2
Standard of Care I/N plus primary disease SBRT
1 of 2

Active Control

Experimental Treatment

78 Total Participants · 2 Treatment Groups

Primary Treatment: SBRT + Ipilimumab/Nivolumab · No Placebo Group · Phase 2

Standard of Care I/N plus primary disease SBRT
Radiation
Experimental Group · 1 Intervention: SBRT + Ipilimumab/Nivolumab · Intervention Types: Radiation
Standard of Care I/N alone
Drug
ActiveComparator Group · 1 Intervention: Ipilimumab/ Nivolumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Ontario Clinical Oncology Group (OCOG)Lead Sponsor
60 Previous Clinical Trials
20,585 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,483 Previous Clinical Trials
3,919,798 Total Patients Enrolled
60 Trials studying Carcinoma, Renal Cell
16,914 Patients Enrolled for Carcinoma, Renal Cell
Aly-Khan Lalani, MDPrincipal InvestigatorJuravinski Cancer Centre

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The disease is classified as intermediate/poor risk based on the IMDC criteria.
The patient is eligible for standard of care delivery of ipilimumab and nivolumab according to the approved product monograph.
Imaging scans can be used to detect metastatic cancer 10 weeks after a screening.
Biopsyproven renalcell carcinoma of any histology.
A lesion in the primary kidney that can be treated with SBRT.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 16th, 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.