A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: First line of the email MUST contain NCT # and Site #.
Study Contact Backup
- Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Locations
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Recruiting
- UZ Gent
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Contact:
- Brant Delafontaine, Site 0017
- Phone Number: +3293320000
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Capital Region
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Copenhagen, Capital Region, Denmark, DK-2100
- Recruiting
- Rigshospitalet
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Contact:
- Kristoffer Rohrberg, Site 0022
- Phone Number: +4535456353
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13385
- Recruiting
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
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Contact:
- Caroline Gaudy, Site 0016
- Phone Number: +33491380000
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Paris
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Villejuif, Paris, France, 94800
- Recruiting
- Gustave Roussy
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Contact:
- Anna PATRIKIDOU, Site 0012
- Phone Number: +3314214211
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Attikí
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Athens, Attikí, Greece, 11527
- Recruiting
- General Hospital of Athens "LAIKO"
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Contact:
- Dimitrios Ziogas, Site 0038
- Phone Number: 306936490499
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Thessaloníki
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Thessaloniki, Thessaloníki, Greece, 564 29
- Recruiting
- Papageorgiou General Hospital of Thessaloniki
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Contact:
- Georgios Lazaridis, Site 0039
- Phone Number: 302313323959
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Lombardy
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Milan, Lombardy, Italy, 20133
- Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Contact:
- Massimo Di Nicola, Site 0037
- Phone Number: 0223902506
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Milano
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Rozzano, Milano, Italy, 20089
- Recruiting
- Istituto Clinico Humanitas
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Contact:
- Matteo Simonelli, Site 0036
- Phone Number: +390282244559
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Rotterdam, Netherlands, 3015 GD
- Recruiting
- Erasmus Medisch Centrum
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Contact:
- Sander Bins, Site 0028
- Phone Number: 3110107040962
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North Holland
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Amsterdam, North Holland, Netherlands, 1066 CX
- Recruiting
- Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
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Contact:
- Tim Schutte, Site 0018
- Phone Number: +3120-5129111
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Madrid, Spain, 28050
- Recruiting
- Hospital Universitario HM Sanchinarro
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Contact:
- Emiliano Calvo, Site 0034
- Phone Number: +34934894304
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
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Contact:
- Elena Garralda Cabanas, Site 0033
- Phone Number: 349327460004910
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Navarre
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Pamplona, Navarre, Spain, 31008
- Recruiting
- Clinica Universidad de Navarra
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Contact:
- Ignacio Melero Bermejo, Site 0035
- Phone Number: 34948255400
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Stockholms Län [se-01]
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Solna, Stockholms Län [se-01], Sweden, 171 64
- Recruiting
- Karolinska Universitetssjukhuset Solna
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Contact:
- Lisa Liu, Site 0023
- Phone Number: 46851770000
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California
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Irvine, California, United States, 92612
- Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center
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Contact:
- Warren Chow, Site 0005
- Phone Number: 626-372-7121
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Los Angeles, California, United States, 90025
- Recruiting
- The Angeles Clinic and Research Institute - West Los Angeles Office
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Contact:
- Omid Hamid, Site 0030
- Phone Number: 310-231-2121
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- Local Institution - 0008
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Contact:
- Site 0008
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center
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Contact:
- Martin Gutierrez, Site 0009
- Phone Number: 551-996-5863
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New York
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Lake Success, New York, United States, 11042
- Recruiting
- Northwell Health/ RJ Zuckerberg Cancer Center
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Contact:
- Nagashree Seetharamu, Site 0007
- Phone Number: 917-574-8494
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Recruiting
- Levine Cancer Institute
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Contact:
- Asim Amin, Site 0011
- Phone Number: 980-442-2000
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutchinson Cancer Center
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Contact:
- Cristina Rodriguez, Site 0010
- Phone Number: 206-288-6748
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
Exclusion Criteria:
- History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
- Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Part 2A
|
Specified dose on specified days
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Experimental: Part 1A
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Specified dose on specified days
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Experimental: Part 1B1
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Specified dose on specified days
Specified dose on specified days
Other Names:
|
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Experimental: Part 1B2
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Specified dose on specified days
Specified dose on specified days
Other Names:
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Experimental: Part 1B3
|
Specified dose on specified days
Specified dose on specified days
|
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Experimental: Part 1C
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Specified dose on specified days
|
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Experimental: Part 2B1
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Specified dose on specified days
Specified dose on specified days
Other Names:
|
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Experimental: Part 2B2
|
Specified dose on specified days
Specified dose on specified days
Other Names:
|
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Experimental: Part 2B3
|
Specified dose on specified days
Specified dose on specified days
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0
Time Frame: Up to Day 28
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Up to Day 28
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Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Number of deaths as assessed by NCI-CTCAE v5.0
Time Frame: Through study completion (Up to 4 years)
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Through study completion (Up to 4 years)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Concentration at the end of infusion (Cmax)
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Time of maximum observed concentration (Tmax)
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
|
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Area under the concentration-time curve in one dosing interval (AUC(TAU))
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator
Time Frame: Up to 135 days post last treatment visit
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Up to 135 days post last treatment visit
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CA236-0001
- 2024-516602-28 (Other Identifier: EU CTR)
- U1111-1309-0886 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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