← Back to Search

Other

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

SAFETY COHORT: Reproductive status requirements for women of childbearing potential and sexually active males

EFFICACY COHORT: Patients with 1-4 tumor sites that can be irradiated safely

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

Select...

I am using effective birth control if I can have children or am sexually active.

Select...

I have 1-4 tumors that can be safely treated with radiation.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My advanced cancer has not responded to standard treatments.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My organ and bone marrow functions are normal.

Select...

I am 18 years old or older.

Select...

My cancer can be measured by tests or scans.

Select...

I have 1 to 4 tumors that can be safely treated with radiation.

Select...

My cancer can be measured by tests or scans.

Select...

My organs and bone marrow are functioning normally.

Select...

My melanoma or kidney cancer has not responded to anti-PD1/PDL1 treatment.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

nivolumab

2016

Completed Phase 3

~4960

Stereotactic Body Radiotherapy (SBRT)

2016

Completed Phase 3

~580

0 / 13Eligibility criteria met

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

2,638 Previous Clinical Trials

4,128,458 Total Patients Enrolled

177 Trials studying Melanoma

57,493 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

Frequently Asked Questions

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

Is recruitment still possible for this research endeavor?

"According to the data hosted on clinicaltrials.gov, this medical study is actively enrolling patients. The initial posting of the trial was October 8th 2021 and it has since been revised in April 19th 2022."

Answered by AI

What primary purpose does BMS-986253 serve for medical practitioners?

"BMS-986253 has been demonstrated to be efficacious at treating malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."

Answered by AI

Has BMS-986253 ever been tested in a prior medical experiment?

"At this moment, 717 research studies are underway concerning BMS-986253. Of those ongoing trials, 82 have reached Phase 3 and the primary investigation hub is in Basel, BE. There are 40281 medical centres across the globe administering tests for this treatment."

Answered by AI

Has BMS-986253 received regulatory clearance from the FDA?

"The limited clinical data available suggests that BMS-986253 is relatively safe, thus receiving a score of 1."

Answered by AI

Is this trial a pioneering venture in its field?

"Presently, 717 studies of BMS-986253 are ongoing in 2356 cities across 49 countries. Ono Pharmaceutical Co. Ltd first conducted a trial for the drug back in 2012; this initial study involved 659 patients and completed both Phase 1 & 2 clinical evaluation stages. Since then, 258 follow-up investigations have been concluded."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov attests that this clinical study, which was originally made available on October 8th 2021, is currently welcoming applicants. The project requires 50 participants from 1 medical centre to be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors

Jason J. Luke, MD 2021. "Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572451.

All > Sbrt > Renal Cell Carcinoma