A Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Liver Cancer who have never been been Treated with Immuno-oncology Therapy after Prior Treatment with Tyrosine Kinase Inhibitors

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

14 Dec 2020 → 19 Nov 2025

Decision date (initial)

2023-06-15

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

2023-503519-13-00

EudraCT number

2018-003151-38

WHO UTN

U1111-1218-6499

ClinicalTrials.gov

NCT04567615

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the efficacy of relatlimab in combination with nivolumab relative to nivolumab monotherapy in IO therapy-naive participants after prior treatment with TKI therapy

Secondary objectives 2

1. - To investigate safety and tolerability of relatlimab in combination with nivolumab in participants with advanced HCC
2. - To further evaluate the preliminary efficacy of relatlimab in combination with nivolumab

Conditions and MedDRA coding

Advanced Hepatocellular Carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. - Male and female participants must be ≥ 18 years at the time of informed consent.
2. - Participants with histologic confirmed advanced/metastatic 2L or 3L HCC.
3. - Participants with pre-treatment tumor tissue sample with evaluable LAG-3 expression level by IHC. Participants with indeterminate or unevaluable LAG-3 status results will not be permitted to receive study treatment or randomize to a treatment arm.
4. - Participants who have experienced progression that was demonstrated radiographically on or after one or two prior TKI therapies without prior exposure to IO agents.
5. - Child-Pugh score of 5 or 6 points (ie, Child-Pugh A).
6. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria 6

1. - Women who are pregnant or breastfeeding
2. - Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
3. - Participants with uncontrolled or significant cardiovascular disease.
4. - Prior organ allograft or allogeneic bone marrow transplantation.
5. - Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
6. - Participants with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary endpoints 5

1. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation
2. Incidence of clinically significant changes in clinical laboratory results: Hematology, Clinical Chemistry and Urinalysis tests
3. Disease control rate (DCR), Duration of response (DOR) and Progression-free survival assessed by BICR per RECIST v1.1
4. ORR, DCR, DOR and PFS assessed by investigator per RECIST v1.1
5. Overall survival (OS)

Investigational products

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

Test 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 15

Locations

5 EU/EEA countries · 18 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 20 files

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

Application history

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