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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

    March 21, 2022

Study Description

Brief summary:

The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) 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 Lunch 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: 520 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: February 2024
  • Estimated Study Completion Date: September 2024

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 1 or 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.
Placebo Comparator: Part 2: Arm D (Nivolumab + Placebo + 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: 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.

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. Progression-free survival (PFS) 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 in biomarker subgroups [ Time Frame: Until progression, up to 21 months ]
    Part 2
  • 6. Overall response rate (ORR) per RECIST v1.1 by BICR [ Time Frame: Up to 21 months ]
    Part 2
  • 7. Incidence of Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 8. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • 9. 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: 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
Montefiore Medical Center
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, North Carolina
Duke University Medical Center
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
Rio Cuarto

Argentina, Distrito Federal
Clinica Adventista Belgrano
Caba

Argentina, LA Rioja
Fundacion CORI para la Investigacion y Prevencion del Cancer
Capital

Argentina, RIO Negro
Clinica Viedma
Viedma

Argentina, Santa FE
Gaston Martinengo
Rosario

Argentina
Local Institution
Cordoba

Argentina
Local Institution
Cordoba

Australia, New South Wales
The Chris OBrien Lifehouse
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
Ballarat Health Services
Ballarat

Australia, Victoria
Bendigo Health - Bendigo Cancer Centre
Bendigo

Australia, Victoria
Box Hill Hospital-Eastern Health
Box Hill

Australia, Victoria
Frankston Hospital - peninsula Health
Frankston

Australia, Western Australia
St John of God Hospital - Murdoch
Murdoch

Australia, Western Australia
Hollywood Private Hospital
Nedlands

Austria
Medical University of Graz
Graz

Austria
Local Institution
Vienna

Belgium
AZ Maria Middelares - Campus Maria Middelares
Ghent

Belgium
Ghent University Hospital
Ghent

Belgium
Local Institution
Liege

Belgium
AZ Delta
Roeselare

Brazil, RIO Grande DO Norte
Local Institution
Natal

Brazil, RIO Grande DO SUL
Local Institution
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
Sao Paulo

Brazil
Local Institution
Sao Paulo

Chile, Metropolitana
Orlandi Oncologia
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Bradford Hill Centro de Investigacion Clinica
Santiago

France
Local Institution
Bordeaux

France
Centre GeorgesFrancois Leclerc
Dijon

France
Centre Hospitalier CH LeMans
Le Mans

France
Hopital Cochin
Paris

France
Hopital Bichat
Paris

France
Institut Curie
Paris

France
Local Institution
Rennes

France
Local Institution
Saint Priest en Jarez

France
Hopital Begin
Saint-Mande

Germany
Vivantes Klinikum Neukoelln Klinik feur Haematologie, Onkologie Und Palliativmedizin
Berlin

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

Germany
Local Institution
Dresden

Germany
KEM Evangelische Kliniken Essen-Mitte
Essen

Germany
LungenClinic Grosshansdorf Onkologie
Grosshansdorf

Germany
Universitatsklinikum des Saarlandes
Homburg

Germany
Klinik Loewenstein gGmbH
Loewenstein

Germany
Philipps-Universitaet Marburg Comprehensive Cancer Center
Marburg

Germany
Local Institution
Paderborn

Germany
Onkologie Ravensburg
Ravensburg

Ireland
St Vincents University Hospital
Dublin

Ireland
Beaumont Hospital
Dublin

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
IFO Regina Elena
Rome

Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena

Mexico, Distrito Federal
Centro Oncologico Medica Sur
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
Oddzial Onkologii I Radioterapii Szpital Morski ImPck
Gdynia

Poland
Local Institution
Lublin

Poland
Specjalistyczna Praktyka Lekarska
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
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

Spain
Hospital Teresa Herrera C.H.U.A.C.
A Coruna

Spain
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO
Badalona

Spain
Hospital de la Santa Creu i Sant Pau
Barcelona

Spain
Hospital Universitario Vall dHebron
Barcelona

Spain
Local Institution
Barcelona

Spain
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Hospital Universitario La Paz
Madrid

Spain
Hospital Regional Universitario Malaga
Malaga

Spain
Hospital Universitario Virgen del Rocio
Sevilla

Spain
Hospital Universitari i Politecnic La Fe
Valencia

Switzerland
University Hospital Basel
Basel

Switzerland
Kantonsspital St. Gallen
St. Gallen

Turkey
Local Institution
Adana

Turkey
Local Institution
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, Surrey
Local Institution
Guildford

United Kingdom
Local Institution
Blackpool

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Manchester

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: CA224-104, 2020-004026-31, U1111-1256-8115
  • First Posted: November 10, 2020 Key Record Dates
  • Last Update Posted: March 21, 2022
  • Last Verified: March 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
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Neoplasms
    Lung Diseases
    Respiratory Tract Diseases
    Carcinoma, Bronchogenic
    Bronchial Neoplasms