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A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

  • Clinicaltrials.gov identifier

    NCT04623775

  • Recruitment Status

    Recruiting

  • First Posted

    November 10, 2020

  • Last update posted

    September 15, 2022

Study Description

Brief summary:

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

  • Condition or Disease:Non-small Cell Lung Cancer
    Recurrent Non-small Cell Lung Cancer
    Metastatic Non-small Cell Lung Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Relatlimab
    Drug: Carboplatin
    Drug: Cisplatin
    Drug: Paclitaxel
    Drug: Nab-Paclitaxel
    Drug: Pemetrexed
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 420 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
  • Actual Study Start Date: February 2021
  • Estimated Primary Completion Date: April 2024
  • Estimated Study Completion Date: October 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Biological: Nivolumab
Specified dose on specified days

Biological: Relatlimab
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Nab-Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Biological: Nivolumab
Specified dose on specified days

Biological: Relatlimab
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Nab-Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Biological: Nivolumab
Specified dose on specified days

Biological: Relatlimab
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Active Comparator: Part 2: Arm D (Nivolumab + PDCT)
Biological: Nivolumab
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Drug: Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Outcome Measures

  • Primary Outcome Measures: 1. Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose [ Time Frame: Up to 10 months, from first participant's first dose ]
    Part 1
  • 2. Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) [ Time Frame: 10 months after randomization, up to 21 months ]
    Part 2
  • Secondary Outcome Measures: 1. Incidence of TRAEs leading to discontinuation [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • 2. Incidence of Adverse Events (AEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • 3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • 4. Incidence of select Adverse Events (AEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • 5. PFS per RECIST v1.1 by BICR [ Time Frame: Up to approximately 3 years ]
    Part 2
  • 6. Overall response rate (ORR) per RECIST v1.1 by BICR [ Time Frame: Up to approximately 2 years ]
    Part 2
  • 7. Duration of Response (DoR) per RECIST v1.1 by BICR [ Time Frame: At 6 months, 12 months, and 18 months ]
    Part 2
  • 8. Incidence of Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 10. Incidence of Treatment Related Adverse Events (TRAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 11. Incidence of Immune-mediated Adverse Events (IMAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 12. Incidence of select Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease Exclusion Criteria: Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy Untreated CNS metastases Leptomeningeal metastases (carcinomatous meningitis) Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease) Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
City of Hope
Arcadia

United States, California
University of California Irvine
Orange

United States, California
Local Institution
Santa Monica

United States, Connecticut
Local Institution
New Haven

United States, Delaware
Local Institution
Newark

United States, Florida
Cancer Specialists of North Florida
Jacksonville

United States, Florida
Hematology Oncology Assoc of the Treasure Coast
Port Saint Lucie

United States, Georgia
University Cancer and Blood Center
Athens

United States, Kansas
Cancer Center of Kansas
Wichita

United States, Kentucky
Baptist Health Lexington
Lexington

United States, Kentucky
Norton Cancer Institute
Louisville

United States, Maine
NECS
Scarborough

United States, Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialist
Omaha

United States, New Jersey
Regional Cancer Care Associates
Howell

United States, New York
$Form.Name
Bronx

United States, New York
Broome Oncology LLC
Johnson City

United States, New York
NYU Perlmutter Cancer Center (Long Island)
Mineola

United States, New York
NYU Perlmutter Cancer Center
New York

United States, New York
$Form.Name
New York

United States, North Carolina
$Form.Name
Durham

United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati

United States, Ohio
Local Institution
Cleveland

United States, Pennsylvania
Lancaster General Health
Lancaster

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh

United States, Rhode Island
Local Institution
Providence

United States, South Carolina
St Francis Cancer Center
Greenville

United States, Texas
Ut Southwestern Medical Center
Dallas

United States, Texas
Valley Cancer Associates PC
Harlingen

United States, Texas
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
Tyler

United States, Washington
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane

United States, West Virginia
Local Institution
Morgantown

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Cordoba
Local Institution - 0037
Rio Cuarto

Argentina, Distrito Federal
Local Institution - 0014
Caba

Argentina, LA Rioja
Local Institution - 0073
Capital

Argentina, RIO Negro
Clinica Viedma
Viedma

Argentina, Santa Fe
Local Institution - 0029
Rosario

Argentina
Local Institution
Cordoba

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution - 0055
Camperdown

Australia, New South Wales
Gosford Hospital
Gosford

Australia, New South Wales
North West Cancer Centre in Tamworth
Tamworth

Australia, Queensland
Icon Cancer Centre
South Brisbane

Australia, Victoria
Local Institution - 0130
Ballarat

Australia, Victoria
Local Institution - 0138
Bendigo

Australia, Victoria
Box Hill Hospital-Eastern Health
Box Hill

Australia, Victoria
Frankston Hospital - peninsula Health
Frankston

Australia, Western Australia
Local Institution - 0119
Murdoch

Australia, Western Australia
Hollywood Private Hospital
Nedlands

Austria
Local Institution - 0090
Graz

Austria
Local Institution
Vienna

Belgium, Lige
Local Institution - 0066
Liege

Belgium, West-Vlaanderen
Local Institution - 0125
Roeselare

Belgium
AZ Maria Middelares - Campus Maria Middelares
Ghent

Belgium
Ghent University Hospital
Ghent

Brazil, RIO Grande DO Norte
Local Institution
Natal

Brazil, RIO Grande DO SUL
Local Institution - 0161
Ijui

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil, SAO Paulo
Local Institution
Santo Andre

Brazil, SAO Paulo
Local Institution
Sao-Paulo

Brazil
Local Institution
Rio de Janeiro

Brazil
Local Institution - 0163
Sao Paulo

Brazil
Local Institution
Sao Paulo

Spain
Local Institution - 0123
Madrid

Spain, Andalucia
Local Institution - 0042
Malaga

Spain, Andalucia
Local Institution - 0075
Sevilla

Spain, Barcelona
Local Institution - 0137
Badalona

Spain, Las Palmas
Local Institution - 0061
Las Palmas de Gran Canaria

Spain
Local Institution - 0051
A Coruna

Spain
Local Institution - 0154
Barcelona

Spain
Local Institution - 0048
Barcelona

Spain
Local Institution - 0024
Barcelona

Spain
Local Institution - 0074
Madrid

Spain
Local Institution - 0043
Valencia

Chile, Metropolitana
Orlandi Oncologia
Santiago

Chile, Metropolitana
Local Institution - 0016
Santiago

Chile, Metropolitana
Local Institution - 0079
Santiago

France, Ille-Et-Vilaine
Local Institution - 0008
Rennes

France
Local Institution
Bordeaux

France
Centre GeorgesFrancois Leclerc
Dijon

France
Local Institution - 0144
Le Mans

France
Local Institution - 0110
Paris

France
Hopital Cochin
Paris

France
Local Institution - 0035
Paris

France
Local Institution
Saint Priest en Jarez

France
Hopital Begin
Saint-Mande

Germany
Local Institution - 0103
Berlin

Germany
Vivantes Klinikum Spandau, Klinik fur Innere Medizin, Haematologie, Onkologie, Palliativmedizin
Berlin

Germany
Local Institution
Dresden

Germany
Local Institution - 0065
Essen

Germany
LungenClinic Grosshansdorf Onkologie
Grosshansdorf

Germany
Local Institution - 0058
Homburg

Germany
Local Institution - 0108
Lowenstein

Germany
Philipps-Universitaet Marburg Comprehensive Cancer Center
Marburg

Germany
Local Institution
Paderborn

Germany
Onkologie Ravensburg
Ravensburg

Ireland
St Vincents University Hospital
Dublin

Ireland
Local Institution - 0023
Dublin

Italy, RA
Local Institution - 0106
Rome

Italy
Istituto di Candiolo - Fondazione del Piemonte per lOncologia IRCCS
Candiolo

Italy
Local Institution
Catania

Italy
Local Institution
Genova Sampierdarena

Italy
IRCCS - Istituto Europeo di Oncologia IEO
Milano

Italy
Local Institution
Monselice

Italy
Local Institution
Ravenna

Italy
Local Institution - 0019
Siena

Mexico, Distrito Federal
Local Institution - 0070
Ciudad de Mexico

Mexico, Estado DE Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Toluca de Lerdo

Mexico, Nuevo LEON
I Can Oncology Center
Monterrey

Mexico, Nuevo LEON
ONCARE
San Pedro Garza Garcia

Netherlands
Local Institution
Arnhem

Netherlands
St. Jansdal Ziekenhuis
Harderwijk

New Zealand
Local Institution
Christchurch

Poland
Local Institution - 0145
Gdynia

Poland
Local Institution
Lublin

Poland
Local Institution - 0031
Lublin

Poland
SP Zespol Gruzlicy i Chorob Pluc
Olsztyn

Poland
Local Institution
Warszawa

Romania
Local Institution
Baia Mare

Romania
Local Institution
Cluj Napoca

Romania
Local Institution
Craiova

Romania
Local Institution
Craiova

Romania
Local Institution
Craiova

Romania
Local Institution
Timisoara

Russian Federation
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk

Russian Federation
Local Institution - 0054
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Nizghiy Novgorod

Russian Federation
FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus
Saint Petersburg

Russian Federation
LLC Eurocityclinic
Saint-Petersburg

Switzerland
University Hospital Basel
Basel

Switzerland
Local Institution - 0104
St. Gallen

Turkey
Local Institution
Adana

Turkey
Local Institution - 0068
Ankara

Turkey
Local Institution
Antalya

Turkey
Local Institution
Diyarbakir

Turkey
Local Institution
Edirne

Turkey
Local Institution
Erzurum

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

United Kingdom, Cleveland
Local Institution
Middlesborough

United Kingdom, Lancashire
Local Institution - 0136
Blackpool

United Kingdom, Lancashire
Local Institution - 0095
Manchester

United Kingdom, Surrey
Local Institution
Guildford

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Nottingham

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04623775 History of Changes
  • Other Study ID Numbers: 2020-004026-31, U1111-1256-8115, CA224-104
  • First Posted: November 10, 2020 Key Record Dates
  • Last Update Posted: September 15, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Stage IV Non-small Cell Lunch Cancer
    Recurrent Non-small Cell Lung Cancer
    Metastatic Non-small Cell Lung Cancer
    Relatlimab
    Nivolumab
    Chemotherapy
  • Additional relevant MeSH terms: Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Recurrence
    Disease Attributes
    Pathologic Processes
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Neoplasms
    Lung Diseases
    Respiratory Tract Diseases
    Carcinoma, Bronchogenic
    Bronchial Neoplasms