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BMS-986288 for Cancer

Local Institution - 0046, Montreal, Canada
CancerBMS-986288 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
BMS-986360
1
BMS-986158
1
ADXS-504

Study Objectives

3 Primary · 28 Secondary · Reporting Duration: Up to 4 years

Day 100
Incidence of AEs leading to death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Up to 2 years
Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
Incidence of AEs leading to laboratory abnormalities
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288
Maximum Observed Concentration (Cmax) of BMS-986288
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review
Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288
Percentage of change from baseline in T-regulatory cells (Tregs)
Time of Maximum Observed Concentration (Tmax) of BMS-986288
Trough Observed Concentrations (Ctrough) of BMS-986288
Up to 4 months
Accumulation Index (AI) of BMS-986288
Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
Terminal Half-Life (T-HALF) of BMS-986288
Total Body Clearance (CLT) of BMS-986288
Up to 4 years
DOR by RECIST v1.1 by blinded independent central review
Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment
Duration of Response (DOR) of Participants
Objective Response Rate (ORR) of Participants
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
Overall Survival (OS) by RECIST v1.1 by blinded independent central review
PFS by RECIST v1.1 by blinded independent central review
Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment
Progression-Free Survival (PFS) of Participants
Time to Response (TTR) by RECIST v1.1 by Investigator Assessment
Time to Response (TTR) of Participants

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
BMS-986360
1
BMS-986158
1
ADXS-504

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

5 Treatment Groups

Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
1 of 5
Arm A: BMS-986288 Monotherapy
1 of 5
Arm B: BMS-986288 in combination with Nivolumab
1 of 5
Arm B BMS-986288 in combination with Nivolumab
1 of 5
Arm A BMS-986288
1 of 5

Experimental Treatment

494 Total Participants · 5 Treatment Groups

Primary Treatment: BMS-986288 · No Placebo Group · Phase 1 & 2

Part 2C: BMS-986288 in combination with Nivolumab and RegorafenibExperimental Group · 3 Interventions: Regorafenib, BMS-986288, Nivolumab · Intervention Types: Drug, Drug, Drug
Arm A: BMS-986288 Monotherapy
Drug
Experimental Group · 1 Intervention: BMS-986288 · Intervention Types: Drug
Arm B: BMS-986288 in combination with NivolumabExperimental Group · 2 Interventions: BMS-986288, Nivolumab · Intervention Types: Drug, Drug
Arm B BMS-986288 in combination with NivolumabExperimental Group · 2 Interventions: BMS-986288, Nivolumab · Intervention Types: Drug, Drug
Arm A BMS-986288
Drug
Experimental Group · 1 Intervention: BMS-986288 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1590
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,542 Previous Clinical Trials
4,019,162 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced cancer and have already tried at least one standard treatment that did not work, or you were not able to tolerate it.
References

Frequently Asked Questions

What is the current enrollment rate for this trial?

"To carry out the trial, Bristol-Myers Squibb needs to recruit 344 eligible individuals. These participants will be coming from Local Institution - 0006 in Saint Louis and Washington University located in Hackensack." - Anonymous Online Contributor

Unverified Answer

Is this research unprecedented in its scope and methodology?

"Since 2012, the development of BMS-986288 has been rigorous and far reaching. Initially sponsored by Ono Pharmaceutical Co. Ltd., its initial trial attracted 659 participants in 2012; this led to Phase 1 & 2 approval from governing bodies. Nowadays, there are 718 studies across 2356 cities spread out over 49 nations tracking outcomes for BMS-986288." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for participation in this research trial?

"The documentation on clinicaltrials.gov verifies that recruitment for this trial is still open, having been first published on the 6th of September 2019 and last modified during October 19th 2022." - Anonymous Online Contributor

Unverified Answer

In what areas can participants access this clinical trial?

"This medical trial is being run in multiple different locations, including Local Institution - 0006 in Saint Louis, Missouri, Washington University in Hackensack, New Jersey and the Hackensack University Medical Center of Baltimore, Maryland." - Anonymous Online Contributor

Unverified Answer

Has the efficacy of BMS-986288 been previously assessed in any other clinical trials?

"BMS-986288 was initially investigated in 2012 at a nearby medical facility. Since then, there have been 252 trials completed and 718 ongoing tests around the world. Most of these are happening in Saint Louis, Missouri." - Anonymous Online Contributor

Unverified Answer

What ailments is BMS-986288 typically prescribed to treat?

"BMS-986288 is regularly prescribed for the management of malignant neoplasms. Additionally, it has been shown to be efficacious in cases where patients have unresectable melanoma, squamous cell carcinoma, or metastatic esophageal adenocarcinoma." - 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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