A Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy in Participants with Stage IV or Recurrent NSCLC

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] - Neoplasms [C04]

Trial duration

19 May 2021 → ongoing

Decision date (initial)

2024-05-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508372-10-00

EudraCT number

2020-004026-31

WHO UTN

U1111-1256-8115

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Part 1
•To evaluate the proportion of participants with TRAEs leading to
discontinuation within 12 weeks after the first dose of nivolumab plus 2
different dose levels of relatlimab (360 mg and 720 mg) in combination
with PDCT in dose safety evaluable participants with histologically
confirmed 1L Stage IV or recurrent NSCLC
Part 2
•To evaluate ORR of nivolumab plus relatlimab in combination with PDCT
relative to nivolumab in combination with PDCT in participants with
histologically confirmed 1L Stage IV or recurrent NSCLC

Secondary objectives 2

1. Part 1 •To evaluate the safety and tolerability of nivolumab plus 2 different doses of relatlimab (360 mg and 720 mg) in combination with PDCT in all participants with histologically confirmed 1L Stage IV or recurrent NSCLC that were treated during the dose safety confirmation period
2. Part 2 •To evaluate the PFS of nivolumab plus relatlimab in combination with PDCT relative to nivolumab in combination with PDCT in participants with histologically confirmed 1L Stage IV or recurrent NSCLC

Conditions and MedDRA coding

Non small Cell Lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Males and females; ≥ 18 years of age or local age of majority.
2. Histologically confirmed metastatic NSCLC of squamous (SQ) or nonsquamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease.
3. Measurable disease by computed tomography or magnetic resonance imaging per Response
4. Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization.
5. No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
6. ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization.
7. Participants must have a life expectancy of at least 3 months at the time of first dose.
8. A formalin-fixed paraffin-embedded tissue block containing enough tissue to cut 20 sections (preferred) or a minimum of 20 unstained slides of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to enrollment (within 3 months of enrollment if stored at 2-8°C or within 2 months of enrollment if stored at ambient temperature and with no intervening systemic anti-cancer treatment between time of acquisition and enrollment) must be sent to the central laboratory.
9. Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization.

Exclusion criteria 9

1. Women who are pregnant or breastfeeding.
2. Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded.
3. Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
4. Participants with untreated central nervous system metastases.
5. Participants with leptomeningeal metastases (carcinomatous meningitis).
6. Concurrent malignancy requiring treatment.
7. Participants with an active, known, or suspected autoimmune disease.
8. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
9. Participants with history of myocarditis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1 •TRAEs leading to discontinuation within 12 weeks after the first dose
2. Part 2 •ORR per RECIST v1.1 by BICR

Secondary endpoints 2

1. Part 1 •Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs
2. Part 2 •PFS per RECIST v1.1 by BICR

Investigational products

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

Test 2

Comparator 5

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 Blanchardstown Corporate Park 2

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 10

Locations

9 EU/EEA countries · 40 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 87 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