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BMS-986253 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Local Institution - 0053, Hamburg, GermanyCancer+1 MoreBMS-986253 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new medication, BMS-986253, in combination with other drugs, to see if it can help treat advanced cancers.

Eligible Conditions
  • Cancer
  • Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
BMS-986253
1
BMS-986360
1
BMS-986158

Study Objectives

4 Primary · 19 Secondary · Reporting Duration: Approximately 5 years

Approximately 5 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Serum
Incidence of AEs
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
Incidence of SAEs
Incidence of adverse events (AE)
Incidence of anti-drug antibody (ADA) to BMS-986253
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Incidence of death
Incidence of deaths
Incidence of serious adverse events (SAE)
Maximum observed serum concentration (Cmax)
Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1
Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Observed serum concentration at the end of a dosing interval (CTAU)
Overall Survival (OS)
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Serum biomarker concentration
Time of maximum observed serum concentration (Tmax)
Trough observed serum concentration at the end of the dosing interval (CTROUGH)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
BMS-986253
1
BMS-986360
1
BMS-986158

Trial Design

5 Treatment Groups

Part 2A: BMS-986253 + nivolumab + ipilimumab
1 of 5
Part 1A: BMS-986253 + nivolumab
1 of 5
Part 1B: BMS-986253 + nivolumab
1 of 5
Part 1C: BMS-986253 + nivolumab + ipilimumab
1 of 5
Part 2B: Placebo + nivolumab + ipilimumab
1 of 5

Experimental Treatment

Non-Treatment Group

372 Total Participants · 5 Treatment Groups

Primary Treatment: BMS-986253 · Has Placebo Group · Phase 1 & 2

Part 2A: BMS-986253 + nivolumab + ipilimumabExperimental Group · 3 Interventions: BMS-986253, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Part 1A: BMS-986253 + nivolumabExperimental Group · 2 Interventions: BMS-986253, Nivolumab · Intervention Types: Drug, Biological
Part 1B: BMS-986253 + nivolumabExperimental Group · 2 Interventions: BMS-986253, Nivolumab · Intervention Types: Drug, Biological
Part 1C: BMS-986253 + nivolumab + ipilimumabExperimental Group · 3 Interventions: BMS-986253, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Part 2B: Placebo + nivolumab + ipilimumabPlaceboComparator Group · 3 Interventions: Ipilimumab, Placebo, Nivolumab · Intervention Types: Biological, Other, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 5 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,515 Previous Clinical Trials
3,945,005 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one lump or growth that can be easily sampled for testing.
References

Frequently Asked Questions

How is BMS-986253 typically employed in medical practice?

"BMS-986253 is frequently used to counteract the effects of anti-angiogenic therapy. It has also been proven effective in treating a range of malignancies, from unresectable melanoma to squamous cell carcinoma." - Anonymous Online Contributor

Unverified Answer

What other investigations have been conducted with regards to BMS-986253?

"BMS-986253 was researched for the first time in 2009 at Texas Children's Hospital. To date, 18672 trials have been completed and 765 are actively recruiting individuals to participate. Notably, a substantial number of these studies can be found around Montréal, Georgia." - Anonymous Online Contributor

Unverified Answer

How many individuals have enrolled in this trial?

"To ensure the success of this research, a total of 372 participants that meet all inclusion criteria must be recruited. Potential recruits can find locations in Montréal, Georgia and Marietta, California." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies for participants in this medical experiment?

"The details of the trial, which were first made public on February 12th 2018 and updated on November 28th 2022, are still available for potential participants to view via clinicialtrials.gov." - Anonymous Online Contributor

Unverified Answer

What expectations has this trial set for its results?

"This long-term trial, which is expected to last approximately 5 years, aims to measure the primary outcome of adverse events meeting pre-determined dose limiting toxicities (DLT) criteria. Secondary objectives include progression free survival hazard ratio based on Blinded Independent Central Review (BICR) assessments per Response Evaluation Criteria in Solid Tumours v1.1 as well as incidence of death and clinically significant changes in clinical laboratory results from urinalysis tests." - Anonymous Online Contributor

Unverified Answer

How many facilities within the state are running this research effort?

"This experimental trial is conducted out of Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies in Montréal, Georgia, Local Institution - 0056 in Marietta, California, and Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital in Los Angeles. Additionally there are 43 other clinical sites participating across the US." - 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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