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)
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04623775
Collaborator
(none)
420
149
4
56.4
2.8
0
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized 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
:
Feb 17, 2021
Anticipated Primary Completion Date
:
Apr 27, 2024
Anticipated Study Completion Date
:
Oct 30, 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
- Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose [Up to 10 months, from first participant's first dose]
Part 1
- Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) [10 months after randomization, up to 21 months]
Part 2
Secondary Outcome Measures
- Incidence of TRAEs leading to discontinuation [Up to 10 months, 30 days from participant's last dose]
Part 1
- Incidence of Adverse Events (AEs) [Up to 10 months, 30 days from participant's last dose]
Part 1
- Incidence of Serious Adverse Events (SAEs) [Up to 10 months, 30 days from participant's last dose]
Part 1
- Incidence of select Adverse Events (AEs) [Up to 10 months, 30 days from participant's last dose]
Part 1
- PFS per RECIST v1.1 by BICR [Up to approximately 3 years]
Part 2
- Overall response rate (ORR) per RECIST v1.1 by BICR [Up to approximately 2 years]
Part 2
- Duration of Response (DoR) per RECIST v1.1 by BICR [At 6 months, 12 months, and 18 months]
Part 2
- Incidence of Adverse Events (AEs) [Up to 21 months]
Part 2
- Incidence of Serious Adverse Events (SAEs) [Up to 21 months]
Part 2
- Incidence of Treatment Related Adverse Events (TRAEs) [Up to 21 months]
Part 2
- Incidence of Immune-mediated Adverse Events (IMAEs) [Up to 21 months]
Part 2
- Incidence of select Adverse Events (AEs) [Up to 21 months]
Part 2
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope | Arcadia | California | United States | 91006 |
| 2 | University of California Irvine | Orange | California | United States | 92868 |
| 3 | Local Institution | Santa Monica | California | United States | 90404 |
| 4 | Local Institution | New Haven | Connecticut | United States | 06520 |
| 5 | Local Institution | Newark | Delaware | United States | 19713 |
| 6 | Cancer Specialists of North Florida | Jacksonville | Florida | United States | 32204 |
| 7 | Hematology Oncology Assoc of the Treasure Coast | Port Saint Lucie | Florida | United States | 34952 |
| 8 | University Cancer and Blood Center | Athens | Georgia | United States | 30607 |
| 9 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214 |
| 10 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 11 | Norton Cancer Institute | Louisville | Kentucky | United States | 40241 |
| 12 | NECS | Scarborough | Maine | United States | 04074 |
| 13 | Oncology Hematology West P.C. dba Nebraska Cancer Specialist | Omaha | Nebraska | United States | 68130 |
| 14 | Regional Cancer Care Associates | Howell | New Jersey | United States | 07731 |
| 15 | $Form.Name | Bronx | New York | United States | 10461 |
| 16 | Broome Oncology LLC | Johnson City | New York | United States | 13790 |
| 17 | NYU Perlmutter Cancer Center (Long Island) | Mineola | New York | United States | 11501 |
| 18 | NYU Perlmutter Cancer Center | New York | New York | United States | 10016 |
| 19 | $Form.Name | New York | New York | United States | 10021 |
| 20 | $Form.Name | Durham | North Carolina | United States | 27710 |
| 21 | University of Cincinnati Cancer Institute | Cincinnati | Ohio | United States | 45219 |
| 22 | Local Institution | Cleveland | Ohio | United States | 44109 |
| 23 | Lancaster General Health | Lancaster | Pennsylvania | United States | 17604 |
| 24 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 25 | Local Institution | Providence | Rhode Island | United States | 02903 |
| 26 | St Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 27 | Ut Southwestern Medical Center | Dallas | Texas | United States | 75060 |
| 28 | Valley Cancer Associates PC | Harlingen | Texas | United States | 78550 |
| 29 | The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center | Tyler | Texas | United States | 75701 |
| 30 | Medical Oncology Associates, PS (dba Summit Cancer Centers) | Spokane | Washington | United States | 99208 |
| 31 | Local Institution | Morgantown | West Virginia | United States | 26506 |
| 32 | Local Institution | Caba | Buenos Aires | Argentina | 1428 |
| 33 | Local Institution - 0037 | Rio Cuarto | Cordoba | Argentina | 5800 |
| 34 | Local Institution - 0014 | Caba | Distrito Federal | Argentina | 1430 |
| 35 | Local Institution - 0073 | Capital | LA Rioja | Argentina | 5300 |
| 36 | Clinica Viedma | Viedma | RIO Negro | Argentina | 8500 |
| 37 | Local Institution - 0029 | Rosario | Santa Fe | Argentina | 2000 |
| 38 | Local Institution | Cordoba | Argentina | 5006 | |
| 39 | Local Institution | Cordoba | Argentina | X5004FHP | |
| 40 | Local Institution - 0055 | Camperdown | New South Wales | Australia | 2050 |
| 41 | Gosford Hospital | Gosford | New South Wales | Australia | 2250 |
| 42 | North West Cancer Centre in Tamworth | Tamworth | New South Wales | Australia | 2340 |
| 43 | Icon Cancer Centre | South Brisbane | Queensland | Australia | 4101 |
| 44 | Local Institution - 0130 | Ballarat | Victoria | Australia | 3350 |
| 45 | Local Institution - 0138 | Bendigo | Victoria | Australia | 3550 |
| 46 | Box Hill Hospital-Eastern Health | Box Hill | Victoria | Australia | 3128 |
| 47 | Frankston Hospital - peninsula Health | Frankston | Victoria | Australia | 3199 |
| 48 | Local Institution - 0119 | Murdoch | Western Australia | Australia | 6150 |
| 49 | Hollywood Private Hospital | Nedlands | Western Australia | Australia | 6009 |
| 50 | Local Institution - 0090 | Graz | Austria | 8036 | |
| 51 | Local Institution | Vienna | Austria | 1090 | |
| 52 | Local Institution - 0125 | Roeselare | West-Vlaanderen | Belgium | 8800 |
| 53 | AZ Maria Middelares - Campus Maria Middelares | Ghent | Belgium | 9000 | |
| 54 | Ghent University Hospital | Ghent | Belgium | 9000 | |
| 55 | Local Institution | Liege | Belgium | 4000 | |
| 56 | Local Institution | Natal | RIO Grande DO Norte | Brazil | 59075-740 |
| 57 | Local Institution - 0161 | Ijui | RIO Grande DO SUL | Brazil | 98700-000 |
| 58 | Local Institution | Porto Alegre | RIO Grande DO SUL | Brazil | 90050170 |
| 59 | Local Institution | Porto Alegre | RIO Grande DO SUL | Brazil | 91350-200 |
| 60 | Local Institution | Barretos | SAO Paulo | Brazil | 14784-400 |
| 61 | Local Institution | Santo Andre | SAO Paulo | Brazil | 09060-650 |
| 62 | Local Institution | Sao-Paulo | SAO Paulo | Brazil | 03102-006 |
| 63 | Local Institution | Rio de Janeiro | Brazil | 20231-050 | |
| 64 | Local Institution | Sao Paulo | Brazil | 04014-002 | |
| 65 | Local Institution | Sao Paulo | Brazil | 08270-120 | |
| 66 | Orlandi Oncologia | Santiago | Metropolitana | Chile | 7500713 |
| 67 | Local Institution - 0016 | Santiago | Metropolitana | Chile | 7500921 |
| 68 | Local Institution - 0079 | Santiago | Metropolitana | Chile | 8420383 |
| 69 | Local Institution - 0008 | Rennes | Ille-Et-Vilaine | France | 35000 |
| 70 | Local Institution | Bordeaux | France | 33076 | |
| 71 | Centre GeorgesFrancois Leclerc | Dijon | France | 21 000 | |
| 72 | Local Institution - 0144 | Le Mans | France | 72037 | |
| 73 | Local Institution - 0110 | Paris | France | 70005 | |
| 74 | Hopital Cochin | Paris | France | 75014 | |
| 75 | Local Institution - 0035 | Paris | France | 75018 | |
| 76 | Local Institution | Saint Priest en Jarez | France | 42271 | |
| 77 | Hopital Begin | Saint-Mande | France | 94160 | |
| 78 | Local Institution - 0108 | Loewenstein | Baden Wuerttenberg | Germany | 74245 |
| 79 | Local Institution - 0103 | Berlin | Germany | 12351 | |
| 80 | Vivantes Klinikum Spandau, Klinik fur Innere Medizin, Haematologie, Onkologie, Palliativmedizin | Berlin | Germany | 13585 | |
| 81 | Local Institution | Dresden | Germany | 01307 | |
| 82 | KEM Evangelische Kliniken Essen-Mitte | Essen | Germany | 45136 | |
| 83 | LungenClinic Grosshansdorf Onkologie | Grosshansdorf | Germany | 22927 | |
| 84 | Local Institution - 0058 | Homburg | Germany | 66421 | |
| 85 | Philipps-Universitaet Marburg Comprehensive Cancer Center | Marburg | Germany | 35043 | |
| 86 | Local Institution | Paderborn | Germany | 33098 | |
| 87 | Onkologie Ravensburg | Ravensburg | Germany | 88212 | |
| 88 | St Vincents University Hospital | Dublin | Ireland | D04 YN63 | |
| 89 | Local Institution - 0023 | Dublin | Ireland | D09V2N0 | |
| 90 | Local Institution - 0106 | Rome | RA | Italy | 00144 |
| 91 | Istituto di Candiolo - Fondazione del Piemonte per lOncologia IRCCS | Candiolo | Italy | 10060 | |
| 92 | Local Institution | Catania | Italy | 95123 | |
| 93 | Local Institution | Genova Sampierdarena | Italy | 16149 | |
| 94 | IRCCS - Istituto Europeo di Oncologia IEO | Milano | Italy | 20141 | |
| 95 | Local Institution | Monselice | Italy | 35043 | |
| 96 | Local Institution | Ravenna | Italy | 48121 | |
| 97 | Local Institution - 0019 | Siena | Italy | 53100 | |
| 98 | Local Institution - 0070 | Ciudad de Mexico | Distrito Federal | Mexico | 14050 |
| 99 | Phylasis Clinicas Research S. de R.L. de C.V. | Toluca de Lerdo | Estado DE Mexico | Mexico | 50090 |
| 100 | I Can Oncology Center | Monterrey | Nuevo LEON | Mexico | 64710 |
| 101 | ONCARE | San Pedro Garza Garcia | Nuevo LEON | Mexico | 66220 |
| 102 | Local Institution | Arnhem | Netherlands | 6815 AD | |
| 103 | St. Jansdal Ziekenhuis | Harderwijk | Netherlands | 3844 DG | |
| 104 | Local Institution | Christchurch | New Zealand | 8013 | |
| 105 | Local Institution - 0145 | Gdynia | Poland | 81-519 | |
| 106 | Local Institution | Lublin | Poland | 20-090 | |
| 107 | Local Institution - 0031 | Lublin | Poland | 20-093 | |
| 108 | SP Zespol Gruzlicy i Chorob Pluc | Olsztyn | Poland | 10-357 | |
| 109 | Local Institution | Warszawa | Poland | 02-781 | |
| 110 | Local Institution | Baia Mare | Romania | 430031 | |
| 111 | Local Institution | Cluj Napoca | Romania | 400015 | |
| 112 | Local Institution | Craiova | Romania | 200094 | |
| 113 | Local Institution | Craiova | Romania | 200347 | |
| 114 | Local Institution | Craiova | Romania | 200385 | |
| 115 | Local Institution | Timisoara | Romania | 300166 | |
| 116 | Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | Russian Federation | 163045 | |
| 117 | Local Institution - 0054 | Moscow | Russian Federation | 115478 | |
| 118 | Local Institution | Moscow | Russian Federation | ||
| 119 | Local Institution | Nizghiy Novgorod | Russian Federation | 603000 | |
| 120 | FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus | Saint Petersburg | Russian Federation | 197376 | |
| 121 | LLC Eurocityclinic | Saint-Petersburg | Russian Federation | 197022 | |
| 122 | Local Institution - 0042 | Malaga | Andalucia | Spain | 29011 |
| 123 | Local Institution - 0075 | Sevilla | Andalucia | Spain | 41013 |
| 124 | Local Institution - 0137 | Badalona | Barcelona | Spain | 08916 |
| 125 | Local Institution - 0061 | Las Palmas de Gran Canaria | Las Palmas | Spain | 35016 |
| 126 | Local Institution - 0051 | A Coruna | Spain | 15006 | |
| 127 | Local Institution - 0154 | Barcelona | Spain | 08025 | |
| 128 | Local Institution - 0048 | Barcelona | Spain | 08035 | |
| 129 | Local Institution - 0024 | Barcelona | Spain | 8036 | |
| 130 | Local Institution - 0074 | Madrid | Spain | 28041 | |
| 131 | Local Institution - 0123 | Madrid | Spain | 28046 | |
| 132 | Local Institution - 0043 | Valencia | Spain | 46026 | |
| 133 | Local Institution - 0104 | St. Gallen | Sankt Gallen (de) | Switzerland | 9007 |
| 134 | University Hospital Basel | Basel | Switzerland | 4031 | |
| 135 | Local Institution | Adana | Turkey | 1330 | |
| 136 | Local Institution - 0068 | Ankara | Turkey | 06490 | |
| 137 | Local Institution | Antalya | Turkey | 07059 | |
| 138 | Local Institution | Diyarbakir | Turkey | 21280 | |
| 139 | Local Institution | Edirne | Turkey | 22030 | |
| 140 | Local Institution | Erzurum | Turkey | 25240 | |
| 141 | Local Institution | Istanbul | Turkey | 34098 | |
| 142 | Local Institution | Istanbul | Turkey | 34722 | |
| 143 | Local Institution | Middlesborough | Cleveland | United Kingdom | TS4 3BW |
| 144 | Local Institution - 0136 | Blackpool | Lancashire | United Kingdom | FY3 8NR |
| 145 | Local Institution - 0095 | Manchester | Lancashire | United Kingdom | M20 4BX |
| 146 | Local Institution | Guildford | Surrey | United Kingdom | GU2 7XX |
| 147 | Local Institution | Leicester | United Kingdom | LE1 5WW | |
| 148 | Local Institution | London | United Kingdom | NW1 2PG | |
| 149 | Local Institution | Nottingham | United Kingdom | NG7 2UH |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04623775
Other Study ID Numbers:
- CA224-104
- 2020-004026-31
- U1111-1256-8115
First Posted:
Nov 10, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 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
Additional relevant MeSH terms: