An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab or Nivolumab plus Ipilimumab in Patients with Advanced Cancers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

22 Nov 2018 → 5 Dec 2025

Decision date (initial)

2024-03-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2023-509061-20-00

EudraCT number

2018-000340-26

WHO UTN

U1111-1208-5119

ClinicalTrials.gov

NCT03400332

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Others

1.To find out if BMS-986253 is safe and determine the best dose of BMS-986253 to give patients in future studies when used with other anti-cancer drugs in advanced solid tumors.
2.To find out how well the treatment of other anti-cancer drugs in combination with BMS-986253 work at treating advanced solid tumors, as compared to when paired with a placebo.

Secondary objectives 4

1. To study how the body processes BMS-986253(called pharmacokinetics (PK)), when used with other anti-cancer drugsin advanced solid tumors.
2. To measure if IL-8 levels in blood change duringtreatment
3. To determine how long a patient lives without the disease getting worse, while being treated with other anti-cancer drugs along with BMS-986253, and to compare this approach with the use of a placebo in place ofBMS-986253 in advanced solid tumors.
4. To find out if it is safe to use other anti-cancer drugs along with BMS-986253, and to compare this approach with the use of a placebo in place of BMS-986253 in advanced solid tumors.

Conditions and MedDRA coding

Advanced solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. At least 1 lesion accessible for biopsy
2. Eastern Cooperative Oncology Group Performance Status of 0 or 1
3. Non-small cell lung carcinoma (only Part 1A and Part 1 Cohorts 1B1 through 1B5 [enrolled through revised Protocol 03]. Participants with NSCLC will not be allowed in Parts 1B6, 1B7 and 1C as per protocol Amendment 04).

Exclusion criteria 6

1. Participants with brain tumors as the only cancer site
2. Participants with autoimmune disease, history of severe side effects from previous anti-cancer therapy, uncontrolled cardiovascular disease, chronic liver inflammation, and other specified conditions.
3. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half- lives or 4 weeks prior to starting study treatment, whichever is shorter.
4. Active infections requiring systemic therapythat is not associated with the underlying tumor.
5. Participantson chronic systemic immunosuppressive therapy or corticosteroids.
6. Pregnancy and Nursing subjects

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Safety: Number and severity of side effects in patients treated with BMS-986253 administered with other medications.
2. Efficacy: Effectiveness of treatment measured by formal response criteria.

Secondary endpoints 3

1. The amount of drug present in the body after one or more doses of BMS-986253 administered in combination with other medications.
2. The amount of IL-8 in blood
3. The length of time during and after treatment that a patient lives with the disease but it does not get worse

Investigational products

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

Test 5

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

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 7

Locations

6 EU/EEA countries · 24 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 33 files

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

Application history

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