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Immunotherapy + SBRT for Solid Cancers

Phase 1
Recruiting
Led By Jason Luke, MD, FACP
Research Sponsored by Jason J. Luke, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EFFICACY COHORT: Patients with 1-4 tumor sites that can be irradiated safely
EFFICACY COHORT: ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of two immunotherapy drugs, nivolumab and anti-IL-8, with radiation to see if it is safe and if it can help treat cancer.

Who is the study for?
This trial is for adults with advanced solid tumors like melanoma or renal cell carcinoma, who have progressed on standard therapies. They must be able to undergo radiation, have normal organ function, and not be pregnant or breastfeeding. Participants need detectable IL-8 levels in their blood and an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The study tests the safety of combining Stereotactic Body Radiotherapy (SBRT) with two immunotherapy drugs: Nivolumab (anti-PD1) and BMS-986253 (anti-IL-8). It aims to find safe radiation doses by organ site when used with these drugs and observe changes in tumor environments.See study design
What are the potential side effects?
Potential side effects include typical immune-related reactions such as inflammation in various organs, fatigue, skin issues, flu-like symptoms, hormonal gland problems, and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 1-4 tumors that can be safely treated with radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organ and bone marrow functions are normal.
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I am 18 years old or older.
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My cancer can be measured by tests or scans.
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I have 1 to 4 tumors that can be safely treated with radiation.
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My cancer can be measured by tests or scans.
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My organs and bone marrow are functioning normally.
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My melanoma or kidney cancer has not responded to anti-PD1/PDL1 treatment.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Rate of Dose Limiting Toxicities (DLT)
Secondary outcome measures
Incidence of grade 3 or higher adverse events
Local tumor control (RECIST v1.1)
Neoplasms
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRTExperimental Treatment3 Interventions
480 mg intravenous nivolumab (BMS-936558-01) every 4 weeks + 2,400 mg intravenous BMS-986253 (Anti-IL-8) every 2 weeks + Stereotactic Body Radiotherapy (SBRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986253
2020
Completed Phase 2
~50
nivolumab
2016
Completed Phase 3
~4960
Stereotactic Body Radiotherapy (SBRT)
2017
Completed Phase 3
~550

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for melanoma include immune checkpoint inhibitors like Nivolumab, which targets the PD-1 pathway, and Ipilimumab, which targets CTLA-4. These inhibitors work by blocking proteins that prevent T-cells from attacking cancer cells, thereby enhancing the immune system's ability to fight the tumor. The combination of Nivolumab and Anti-IL-8 (BMS-986253) with radiation aims to further improve response rates by not only inhibiting the PD-1 pathway but also reducing inflammation and altering the tumor microenvironment through IL-8 inhibition. This multi-faceted approach is crucial for melanoma patients as it can potentially lead to more effective and durable responses, especially in those who do not respond to monotherapy.

Find a Location

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
666 Total Patients Enrolled
3 Trials studying Melanoma
650 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,775 Total Patients Enrolled
177 Trials studying Melanoma
57,344 Patients Enrolled for Melanoma
Jason Luke, MD, FACPPrincipal InvestigatorUPMC Hillman Cancer Center

Media Library

BMS-986253 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04572451 — Phase 1
Melanoma Research Study Groups: Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRT
Melanoma Clinical Trial 2023: BMS-986253 Highlights & Side Effects. Trial Name: NCT04572451 — Phase 1
BMS-986253 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572451 — Phase 1
~14 spots leftby Jun 2025