Relatlimab + Nivolumab in Pediatric and Young Adult Lymphomas (RELATIVITY-069)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Dec 2022 → 4 Dec 2025

Decision date (initial)

2023-09-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation, Belgium

External identifiers

EU CT number

2023-503715-14-00

EudraCT number

2021-000493-29

WHO UTN

U1111-1264-4062

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Others, Pharmacogenomic

Part A: To characterize the safety, tolerability, and define the MTD or
RP2D for the combination of relatlimab + nivolumab in pediatric
participants less than 18 years of age with R/R cHL and NHL.
Part A: To characterize the PK of relatlimab for the combination of
relatlimab + nivolumab in pediatric participants less than 18 years of
age with R/R cHL and NHL.
Part B: To assess the preliminary efficacy of relatlimab + nivolumab
based on the RP2D from part A in participants less than or equal to 30
years old with cHL (Cohort 1).

Secondary objectives 1

1. Part B: To assess the safety of relatlimab + nivolumab in R/R cHL (Cohort 1) and NHL (Cohort2) Part B: To evaluate the ORR of relatlimab + nivolumab in participants ≤ 30 years of age with cHL (Cohort 1)

Conditions and MedDRA coding

Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male and female participants less than 18 years of age (Part A), and less than or equal to 30 years of age (Part B) with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Cohort 1) and Non Hodgkin Lymphoma (NHL) (Cohort 2).
2. Participants with pathologically confirmed high-risk R/R cHL, after non-response to or failure of 1 or more lines of standard therapy.
3. Participants with pathologically confirmed R/R NHL after non-response to or failure of 1 or more lines of standard therapy, including, but not limited to, R/R primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL).
4. The participant's current disease state must be R/R to standard therapy.
5. Participants must have measurable PET positive disease in both cHL and NHL cohorts.
6. Participants with pathologically confirmed R/R NHL after non-response to or failure of 2 or more lines of standard therapy, including Burkitt lymphoma (blast count < 25% malignant Burkitt cells and/or per the investigator's clinical assessment of risk status), lymphoblastic lymphoma (blast count < 25% of marrow nucleated cells and/or per the investigator's clinical assessment of risk status), NK/T-cell lymphoma (nasal and non-nasal NK/T-cell lymphoma subtypes, but not aggressive NK/T-cell leukemia/lymphoma subtype).

Exclusion criteria 7

1. Primary CNS lymphoma of the brain or spinal cord, and secondary CNS lymphoma (ie, from systemic non-Hodgkin lymphoma) involving the brain, spinal cord, or with leptomeningeal seeding.
2. Prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, with the exception of anti-PD(L)-1 targeted therapies.
3. Prior treatment with LAG-3-targeted agents.
4. Participants with a history of allogeneic bone marrow transplantation.
5. Participants with clinically significant systemic illnesses unrelated to the cancer as judged by the investigators, which would compromise the participant's ability to tolerate the study treatment.
6. Participants with autoimmune disease.
7. Participants who are pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1/Part A- Dose-limiting toxicities (DLTs), Maximum Tolerated Dose/Recommended Phase 2 Dose; (MTD/RP2D), and incidences of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths and laboratory abnormalities
2. 2/Part A- maximum observed serum concentration (Cmax), trough observed concentration (Ctrough), time to maximum concentration (Tmax), and area under the curve within a dosing interval (AUC(TAU)) for relatlimab
3. 3/Part B- Complete Metabolic Response (CMR) rate

Secondary endpoints 2

1. 1/Part B: Incidences of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities
2. 2/Part B: Overall Response Rate (ORR)

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 10

Locations

4 EU/EEA countries · 30 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 119 files

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

Application history

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