A Phase 1/2 Study of BMS-986408 with and without Nivolumab or Nivolumab and Ipilimumab in Participants with Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb International Corporation, Bristol-Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Apr 2024 → 25 Jul 2025

Decision date (initial)

2023-08-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb

External identifiers

EU CT number

2022-500823-61-00

WHO UTN

U1111-1272-7269

ClinicalTrials.gov

NCT05407675

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Others, Pharmacokinetic

To characterize the safety and tolerability, and to establish the MTD, maximum administered dose, and/or RP2D(s), and optimal schedule of oral BMS-986408, administered as monotherapy and in combination with nivolumab or nivolumab and ipilimumab, to participants with advanced cancer

Secondary objectives 2

1. To characterize the PK profile of BMS-986408 following oral administration as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to participants with advanced solid tumors.
2. To evaluate the preliminary anti-tumor activity of BMS-986408 as a monotherapy and in combination with nivolumab or nivolumab and ipilimumab in participants with advanced cancer.

Conditions and MedDRA coding

Advanced Solid Tumours

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Males or females ≥ 18 years of age
2. Participants in Groups A and B must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
3. Participants in Groups C, D and E must have a histologically or cytologically confirmed, advanced, unresectable/metastatic malignancy measurable by RECIST v1.1, with the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-(L)1 or anti-CTLA-4 agents, and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

Exclusion criteria 5

1. An active, known or suspected autoimmune disease
2. Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
3. Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
4. Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
5. Women who are breastfeeding or are pregnant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of DLTs, AEs, SAEs, AEs leading to discontinuation, and deaths.

Secondary endpoints 2

1. Summary measures of BMS-986408 PK parameters in plasma, such as, but not limited to, Cmax, Tmax, and AUC (0-T), from concentration-time data during BMS-986408 monotherapy and in combination with nivolumab or nivolumab and ipilimumab.
2. ORR and DOR per RECIST v1.1.

Investigational products

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

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb International Corporation

Sponsor organisation

Bristol-Myers Squibb International Corporation

Address

Chaussee De La Hulpe 185

City

Watermael-Boitsfort

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol-Myers Squibb International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 5

Bristol-Myers Squibb International Corporation

Sponsor organisation

Bristol-Myers Squibb International Corporation

Address

Avenue De Finlande 4

City

Braine-L'alleud

Postcode

1420

Country

Belgium

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Application history

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