A Phase 1/2 Study of BMS-986482 Alone or Combination Therapy in Participants with Advanced Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 Nov 2025 → ongoing

Decision date (initial)

2025-08-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2024-516602-28-00

WHO UTN

U1111-1309-0886

ClinicalTrials.gov

NCT06697197

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Dose response, Pharmacodynamic

To check if BMS-986482 is safe and well-tolerated when given alone or in combination with nivolumab subcutaneous (SC), nivolumab + relatlimab fixed dose combination subcutaneous (FDC SC) or bevacizumab, to find out the recommended phase 2 dose (RP2D) of BMS-986482 in participants with advanced solid tumors.

Secondary objectives 2

1. To characterize the plasma pharmacokinetic (PK) of BMS-986482 given alone or in combination with nivolumab SC, nivolumab + relatlimab FDC SC, or bevacizumab participants with advanced solid tumors.
2. To assess additional preliminary efficacy or BMS-986482 alone or in combination with nivolumab SC, nivolumab + relatlimab FDC SC, or bevacizumab.

Conditions and MedDRA coding

Advanced Solid Tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participants must have an advanced and non-removable or metastatic solid tumor
2. Participants must be 18 years or older
3. Part 1A: participants can have specific types of cancer such as lung, head and neck, colorectal, stomach, bladder, pancreatic, melanoma, or breast cancer
4. Part 1B1 and 2B1: participants must have non-small cell lung cancer (NSCLC) and should know certain genetic markers of their cancer
5. Part 1B1 and 2B1: They should also have previously received platinum-based chemotherapy and anti-PD-(L)1 therapy if eligible
6. 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
7. For part 1B3: participants must have advanced or metastatic colorectal cancer that is resistant or intolerant to fluoropyrimidine and oxaliplatin
8. For part 2A: participants can have advanced or difficult-to-remove solid tumors including NSCLC, hormone-resistant breast cancer, or pancreatic cancer
9. For part 2B3: participants must have advanced or metastatic colorectal cancer
10. 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.

Exclusion criteria 2

1. 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)
2. 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 and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 2

1. To include a summary of the exposure levels of the study drug up to the last pharmacokinetics sampling time point.
2. To evaluate the overall response rate (ORR) up to last tumor assessments until disease progression or death.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 12

Locations

8 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 96 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications