Clinical trial • Phase I/II • Oncology
BMS-986482 for Advanced solid tumors
Phase I/II trial of BMS-986482 for Advanced solid tumors. Randomised, adaptive. 28 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 18-08-2025
Trial design
Randomised, adaptive Phase I/II trial in Sweden, France, Spain and others.
- Randomised
- Yes
- Adaptive
- True, dose-escalation to determine the recommended phase 2 dose (RP2D) with DLT evaluation and safety monitoring described as a primary endpoint
- Biomarker Stratified
- True, genetic markers of NSCLC (specific markers not specified in the record)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 28
Eligibility
Recruits 28 No vulnerable populations selected (isVulnerablePopulationSelected: false); participants must be 18 years or older..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); participants must be 18 years or older.
Inclusion criteria
- {"criterion_text":"- Participants must have an advanced and non-removable or metastatic solid tumor"}
- {"criterion_text":"- All participants in the initial parts of the study must provide a recent tumor biopsy sample taken within a month before the screening if it is safe to do so. There is flexibility in the types of tumors included in the different parts."}
- {"criterion_text":"- Participants must be 18 years or older"}
- {"criterion_text":"- Part 1A: participants can have specific types of cancer such as lung, head and neck, colorectal, stomach, bladder, pancreatic, melanoma, or breast cancer"}
- {"criterion_text":"- Part 1B1 and 2B1: participants must have non-small cell lung cancer (NSCLC) and should know certain genetic markers of their cancer"}
- {"criterion_text":"- Part 1B1 and 2B1: They should also have previously received platinum-based chemotherapy and anti-PD-(L)1 therapy if eligible"}
- {"criterion_text":"- Part 1B1 and 2B1: For parts of the study involving melanoma (Parts 1B2, 2B2, and 1C), participants can have certain types of melanoma but not uveal (eye) melanoma and must have had previous melanoma treatments"}
- {"criterion_text":"- For part 1B3: participants must have advanced or metastatic colorectal cancer that is resistant or intolerant to fluoropyrimidine and oxaliplatin"}
- {"criterion_text":"- For part 2A: participants can have advanced or difficult-to-remove solid tumors including NSCLC, hormone-resistant breast cancer, or pancreatic cancer"}
- {"criterion_text":"- For part 2B3: participants must have advanced or metastatic colorectal cancer"}
Exclusion criteria
- {"criterion_text":"- They have had a life-threatening reaction related to earlier treatments that stimulate the immune system or block immune checkpoints (like anti-CTLA-4 or anti-PD-1/PD-L1 therapies), unless the reaction is manageable and unlikely to happen again (for example, needing hormone therapy after an adrenal issue)"}
- {"criterion_text":"- They have a serious medical condition—either long-term or sudden—that the study doctor believes could interfere with the treatment or follow-up during the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- To evaluate the incidence of adverse events (AEs), serious adverse events (SAEs), AEs meeting protocol-defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death up to safety follow-up visit occurs.","definition_or_measurement_approach":"Incidence of AEs, SAEs, protocol-defined DLTs, AEs leading to discontinuation, and deaths will be recorded and evaluated up to the safety follow-up visit."}
Secondary endpoints
- {"endpoint_text":"- To include a summary of the exposure levels of the study drug up to the last pharmacokinetics sampling time point.","definition_or_measurement_approach":"Summary of drug exposure levels up to the last PK sampling time point (pharmacokinetic sampling)."}
- {"endpoint_text":"- To evaluate the overall response rate (ORR) up to last tumor assessments until disease progression or death.","definition_or_measurement_approach":"Overall response rate measured up to the last tumor assessment, censored at disease progression or death."}
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent obtained from each participant (study population limited to adults >=18 years). Subject information sheets and ICFs are available for multiple countries and languages (document titles indicate country-specific ICFs in English, French, Spanish, Dutch, Greek, Italian, Swedish and others). No assent process described in the record.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 62
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 276
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Fas 1-enheten Solna, Medicinsk enhet Centrum för Kliniska Cancerstudier (CKC), Tema Cancer
- Principal Investigator Name
- Lisa Liu Burström
- Principal Investigator Email
- isa.liu-burstrom@regionstockholm.se
- Contact Person Name
- Lisa Liu Burström
- Contact Person Email
- isa.liu-burstrom@regionstockholm.se
France
- Earliest CTIS Part Ii Submission Date
- 13-06-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 305
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Anna Patrikidou
- Principal Investigator Email
- anna.patrikidou@gustaveroussy.fr
- Contact Person Name
- Anna Patrikidou
- Contact Person Email
- anna.patrikidou@gustaveroussy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d'Essais Précoces en Cancérologie de Marseille
- Principal Investigator Name
- Caroline Gaudy
- Principal Investigator Email
- caroline.gaudy@ap-hm.fr
- Contact Person Name
- Caroline Gaudy
- Contact Person Email
- caroline.gaudy@ap-hm.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 09-06-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 316
- Number Of Sites
- 4
- Number Of Participants
- 14
Sites
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Principal Investigator Name
- Ignacio Melero
- Principal Investigator Email
- imelero@unav.es
- Contact Person Name
- Ignacio Melero
- Contact Person Email
- imelero@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Principal Investigator Name
- Ignacio Melero
- Principal Investigator Email
- imelero@unav.es
- Contact Person Name
- Ignacio Melero
- Contact Person Email
- imelero@unav.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Emiliano Calvo Aller
- Principal Investigator Email
- emiliano.calvo@startmadrid.com
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 269
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Drug Research Unit Ghent
- Principal Investigator Name
- Brant Delafontaine
- Principal Investigator Email
- brant.delafontaine@uzgent.be
- Contact Person Name
- Brant Delafontaine
- Contact Person Email
- brant.delafontaine@uzgent.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 259
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Kristoffer Rohrberg
- Principal Investigator Email
- kristoffer.staal.rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 10-07-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 280
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncology
- Principal Investigator Name
- Massimo Di Nicola
- Principal Investigator Email
- massimo.dinicola@istitutotumori.mi.it
- Contact Person Name
- Massimo Di Nicola
- Contact Person Email
- massimo.dinicola@istitutotumori.mi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncology
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simoneli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simoneli@cancercenter.humanitas.it
Greece
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 270
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Clinic of Medical Oncology
- Principal Investigator Name
- Georgios Lazaridis
- Principal Investigator Email
- georlaz@yahoo.gr
- Contact Person Name
- Georgios Lazaridis
- Contact Person Email
- georlaz@yahoo.gr
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- First Department of Internal Medicine
- Principal Investigator Name
- Dimitrios Ziogas
- Principal Investigator Email
- ziogasdc@gmail.com
- Contact Person Name
- Dimitrios Ziogas
- Contact Person Email
- ziogasdc@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 291
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal Oncology
- Principal Investigator Name
- Sander Bins
- Principal Investigator Email
- TMonco.ctc@erasmusmc.nl
- Contact Person Name
- Sander Bins
- Contact Person Email
- TMonco.ctc@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Tim Schutte
- Principal Investigator Email
- CPM-CRU@nki.nl
- Contact Person Name
- Tim Schutte
- Contact Person Email
- CPM-CRU@nki.nl
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
- Name
- QPS LLC
- Responsibilities
- TS and BioA
- Name
- Iqvia Holdings Inc.
- Responsibilities
- site payments
- Name
- Navigate Biopharma Services Inc.
- Responsibilities
- Analyzing lab to generate exploratory FIHC CD3/CD8/HLA-DP, DQ, DR/LAG3/PD1/CK-Sox10 multiplex
Third parties
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"TS and BioA","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Serum PK and serum immunogenicity assay (nivolumab and relatlimab)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions - Innovation Labs","duties_or_roles":"Genomic Analysis","organisation_type":"Health care"}
- {"country":"United States","full_name":"Ampersand Biosciences LLC","duties_or_roles":"exploratory soluble factor analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
- {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"Analyzing lab to generate exploratory FIHC CD3/CD8/HLA-DP, DQ, DR/LAG3/PD1/CK-Sox10 multiplex","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Speciality Biomarker Laboratory, IHC Biomarker expression analysis (PD-L1)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"site payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Indica Labs Inc.","duties_or_roles":"Immunofluorescence (IF) analysis. Image analysis for exploratory biomarker testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics, LLC","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- BMS986482
- Active Substance
- BMS-986482
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Investigational Product Name
- Nivolumab Subcutaneous
- Active Substance
- NIVOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Investigational Product Name
- FDC Nivolumab + Relatlimab + rHuPH20 Injection
- Active Substance
- NIVOLUMAB, RELATLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS
- Investigational Product Name
- BEVACIZUMAB
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- Intravenous infusion
- Combination Treatment
- Yes
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