A Phase 1/2 Study of BMS-986525 with and without Nivolumab in Relapsed/Refractory Small Cell Lung Cancer

Status Authorised, recruitment pending · 3 EU/EEA countries · 4 sites · Protocol CA258-0001

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans

Status Authorised, recruitment pending

Participants planned 42

Countries 3

Sites 4

Relapsed/Refractory Small Cell Lung Cancer

To test if BMS-986525 alone or in combination with nivolumab is safe and well-tolerated and to determine the recommended dose for further testing up to the highest dose of BMS-986453 that can be given without causing severe side effects in patients with Relapsed and/or Refractory SCLC(R/RSCLC)

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]
Decision date (initial): 2026-05-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-524090-16-00
WHO UTN: U1111-1329-5453
ClinicalTrials.gov: NCT07325136

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

Secondary objectives 2

To understand how BMS-986525 is processed in the body (pharmacokinetics; PK) being administered alone or in combination with nivolumab.
To assess how effective BMS-986525 alone or in combination with nivolumab is in treating R/RSCLC.

Conditions and MedDRA coding

Relapsed/Refractory Small Cell Lung Cancer

Version	Level	Code	Term	System organ class
21.1	PT	10041067	Small cell lung cancer	100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Participants who have had their SCLC come back after previous treatment (relapsed) or have SCLC that is not responding to current treatment (refractory)
Participants must have received at least 1 platinum-based chemotherapy regimen.
In countries where the usual first treatment for SCLC includes a combination of platinum-based chemotherapy and anti-PD-(L)1 therapy, participants must have either tried and not responded to anti-PD-(L)1 therapy, not be able to receive it, or not have access to it.
Participants must have adequate organ function.

Exclusion criteria 3

Participants must not have any untreated central nervous system (CNS) involvement of SCLC.
Participants must not have active, known or suspected autoimmune disease.
Participants must not have previously received an organ or tissue transplant from another person.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Type, frequency, and severity of side effects.

Secondary endpoints 2

How BMS-986525 behaves in the body alone and in combination with nivolumab;
How disease responds to BMS-986525 alone or in combination with nivolumab.

Investigational products

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

Test 2

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD2941375 · Product

Active substance: Nivolumab
Substance synonyms: BMS936558, ABP 206
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENUS USE
Authorisation status: Authorised
ATC code: L01FF01 — -
Marketing authorisation: EU/1/15/1014/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The product will be removed from the carton, over-labeled, and repackaged.

BMS-986525

PRD13351861 · Product

Active substance: BMS-986525
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS INFUSION
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

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 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 10

Organisation	City, country	Duties
Labcorp Central Laboratory Services SARL ORG-100011524	Meyrin, Switzerland	Other
Accenture Solutions Private Limited ORG-100032592	Chennai, India	Other
Illumina Inc. ORG-100049125	San Diego, United States	Other
Rules Based Medicine Inc. ORG-100043610	Austin, United States	Other
Iqvia Inc. ORG-100010622	Durham, United States	Other
Perceptive Informatics Inc. ORG-100013171	Burlington, United States	Other
Azenta Germany GmbH ORG-100022621	Griesheim, Germany	Other
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other
Accenture Solutions Private Limited ORG-100032592	Bangaluru, India	Other
Medidata Solutions Inc. ORG-100016256	New York, United States	Other

Locations

3 EU/EEA countries · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Authorised, recruitment pending	5	1
Romania	Authorised, recruitment pending	10	2
Spain	Authorised, recruitment pending	6	1
Rest of world Japan, United States	—	21	—

Investigational sites

Italy

1 site · Authorised, recruitment pending

Humanitas Mirasole S.p.A.

Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano

Romania

2 sites · Authorised, recruitment pending

Centrul De Oncologie SF Nectarie S.R.L.

Oncology, Strada Caracal Nr 109, 200542, Craiova

Oncohelp Medical Center

Oncology, Ciprian Porumbescu 57-59, 300239, Timisoara

Spain