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BMS-986253 for Melanoma

University of Chicago Medical Center, Chicago, IL
Melanoma+2 More ConditionsBMS-986253 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Melanoma
  • Renal Cell Carcinoma
  • Unresectable Solid Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 3 years

Year 1
Incidence of grade 3 or higher adverse events
Up to 3 years
Local tumor control (RECIST v1.1)
Neoplasms
Objective Response
Overall survival (OS)
Progression-free survival (PFS)
Week 8
Rate of Dose Limiting Toxicities (DLT)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Pembrolizumab
1
BMS-986158
1
Tumor Treating Fields Therapy

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRT
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: BMS-986253 · No Placebo Group · Phase 1

Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRTExperimental Group · 3 Interventions: BMS-986253, nivolumab, Stereotactic Body Radiotherapy (SBRT) · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
759 Total Patients Enrolled
3 Trials studying Melanoma
724 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,537 Previous Clinical Trials
4,019,212 Total Patients Enrolled
176 Trials studying Melanoma
58,449 Patients Enrolled for Melanoma
Jason Luke, MD, FACPPrincipal InvestigatorUPMC Hillman Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a solid tumor that has spread and cannot be removed with surgery. You have already tried standard treatments without success. If you have melanoma or RCC, you may be eligible for the study.
You have 1 to 4 tumors that can be treated with radiation therapy without causing harm.
You have melanoma or RCC that has not responded to anti-PD1/PDL1 treatment. You have 1-4 tumors that can be safely treated with radiation. You have detectable serum IL-8 levels (> 10 pg/mL) before treatment. You are at least 18 years old and have a good performance status. Your organs and bone marrow function normally. You have at least one measurable lesion that is at least 1 cm in diameter. You understand the study and agree to sign a consent form.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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