A Phase 1/2 Study of BMS-986449 with and without Nivolumab in Participants with 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] - Nutritional and Metabolic Diseases [C18]

Trial duration

19 Oct 2023 → ongoing

Decision date (initial)

2023-10-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503484-42-00

WHO UTN

U1111-1287-3575

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

To characterize the safety and tolerability of oral BMS-986449 as monotherapy and in combination with nivolumab, to participants with advanced cancer.

Secondary objectives 1

1. To characterize the pharmacokinetic (PK) profile of BMS-986449 following oral administration as monotherapy and in combination with nivolumab to participants with advanced solid tumors.

Conditions and MedDRA coding

Advanced, metastatic, solid malignancy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants ≥18 years of age with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor - Part 1A, participants may have a solid malignancy of any histology - Part1B is restricted to participants with NSCLC - Part 1C is restricted to participants with TNBC
2. Participants must have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
3. Participants must have measurable disease per RECIST v 1.1.
4. Tumor biopsy must be obtained for all participants (unless medically precluded)

Exclusion criteria 6

1. Participants with active, known or suspected autoimmune disease.
2. Participants with a condition requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days of randomization
3. Participant with prior organ or tissue allograft
4. Participants with history of ≥ Gr 3 toxicity related to prior T cell agonist or checkpoint inhibitor therapy (eg, anti-CTLA-4, or anti-PD-1/PD-L1 treatment, or any other antibody or drug specifically targeting T cell co-stimulation or other immune checkpoint pathways).
5. Participants with any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
6. Participants with untreated or symptomatic CNS metastases or leptomeningeal metastases.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of dose-limiting toxicities, adverse events (AEs), serious AEs (SAEs, adverse events leading to discontinuation, and deaths based on NCI-CTCAE v5.0

Secondary endpoints 1

1. Summary of pharmacokinetic parameters of BMS-986449 and its metabolite in plasma (e.g. maximum observed concentration within a dosing interval, time of maximum observed concentration and area under the concentration–time curve within a dosing interval from concentration–time data during BMS986449 monotherapy and in combination with nivolumab.

Investigational products

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

Test 2

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, Ballycoolin Ballycoolin

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 7

Locations

5 EU/EEA countries · 17 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 61 files

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

Application history

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