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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04623775




Registration number
NCT04623775
Ethics application status
Date submitted
5/11/2020
Date registered
10/11/2020
Date last updated
6/06/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2020-004026-31
Secondary ID [2] 0 0
CA224-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Recurrent Non-small Cell Lung Cancer 0 0
Metastatic Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Relatlimab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-Paclitaxel
Treatment: Drugs - Pemetrexed

Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) -

Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT)) -

Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT) -

Active comparator: Part 2: Arm D (Nivolumab + PDCT) -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Relatlimab
Specified dose on specified days

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

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

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

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

Treatment: Drugs: Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose
Timepoint [1] 0 0
Up to 10 months, from first participant's first dose
Primary outcome [2] 0 0
Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR)
Timepoint [2] 0 0
10 months after randomization, up to 21 months
Secondary outcome [1] 0 0
Incidence of TRAEs leading to discontinuation
Timepoint [1] 0 0
Up to 10 months, 30 days from participant's last dose
Secondary outcome [2] 0 0
Incidence of Adverse Events (AEs)
Timepoint [2] 0 0
Up to 10 months, 30 days from participant's last dose
Secondary outcome [3] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to 10 months, 30 days from participant's last dose
Secondary outcome [4] 0 0
Incidence of select Adverse Events (AEs)
Timepoint [4] 0 0
Up to 10 months, 30 days from participant's last dose
Secondary outcome [5] 0 0
PFS per RECIST v1.1 by BICR
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Overall response rate (ORR) per RECIST v1.1 by BICR
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Duration of Response (DoR) per RECIST v1.1 by BICR
Timepoint [7] 0 0
At 6 months, 12 months, and 18 months
Secondary outcome [8] 0 0
Incidence of Adverse Events (AEs)
Timepoint [8] 0 0
Up to 21 months
Secondary outcome [9] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Up to 21 months
Secondary outcome [10] 0 0
Incidence of Treatment Related Adverse Events (TRAEs)
Timepoint [10] 0 0
Up to 21 months
Secondary outcome [11] 0 0
Incidence of Immune-mediated Adverse Events (IMAEs)
Timepoint [11] 0 0
Up to 21 months
Secondary outcome [12] 0 0
Incidence of select Adverse Events (AEs)
Timepoint [12] 0 0
Up to 21 months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/09/2025
Actual
Sample size
Target
Accrual to date
Final
468
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0055 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0086 - Gosford
Recruitment hospital [3] 0 0
Local Institution - 0132 - Tamworth
Recruitment hospital [4] 0 0
Local Institution - 0057 - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0130 - Ballarat
Recruitment hospital [6] 0 0
Local Institution - 0138 - Bendigo
Recruitment hospital [7] 0 0
Local Institution - 0141 - Box Hill
Recruitment hospital [8] 0 0
Local Institution - 0109 - Frankston
Recruitment hospital [9] 0 0
Local Institution - 0119 - Murdoch
Recruitment hospital [10] 0 0
Local Institution - 0085 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2340 - Tamworth
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3550 - Bendigo
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Distrito Federal
Country [21] 0 0
Argentina
State/province [21] 0 0
RIO Negro
Country [22] 0 0
Argentina
State/province [22] 0 0
Santa Fe
Country [23] 0 0
Argentina
State/province [23] 0 0
La Rioja
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Belgium
State/province [26] 0 0
Ghent
Country [27] 0 0
Belgium
State/province [27] 0 0
Roeselare
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Norte
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
RIO Grande DO SUL
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
SAO Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio de Janeiro
Country [34] 0 0
Chile
State/province [34] 0 0
Metropolitana
Country [35] 0 0
France
State/province [35] 0 0
Ile De France
Country [36] 0 0
France
State/province [36] 0 0
Ille-Et-Vilaine
Country [37] 0 0
France
State/province [37] 0 0
Dijon
Country [38] 0 0
France
State/province [38] 0 0
Le Mans
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Saint-Mande
Country [41] 0 0
Germany
State/province [41] 0 0
NRW
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Grosshansdorf
Country [44] 0 0
Germany
State/province [44] 0 0
Homburg
Country [45] 0 0
Germany
State/province [45] 0 0
Lowenstein
Country [46] 0 0
Germany
State/province [46] 0 0
Marburg
Country [47] 0 0
Germany
State/province [47] 0 0
Paderborn
Country [48] 0 0
Germany
State/province [48] 0 0
Ravensburg
Country [49] 0 0
Ireland
State/province [49] 0 0
Dublin
Country [50] 0 0
Italy
State/province [50] 0 0
RA
Country [51] 0 0
Italy
State/province [51] 0 0
Candiolo
Country [52] 0 0
Italy
State/province [52] 0 0
Catania
Country [53] 0 0
Italy
State/province [53] 0 0
Genova
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Italy
State/province [55] 0 0
Pesaro
Country [56] 0 0
Italy
State/province [56] 0 0
Siena
Country [57] 0 0
Mexico
State/province [57] 0 0
Distrito Federal
Country [58] 0 0
Mexico
State/province [58] 0 0
Estado DE Mexico
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo LEON
Country [60] 0 0
Netherlands
State/province [60] 0 0
Gelderland
Country [61] 0 0
Netherlands
State/province [61] 0 0
Arnhem
Country [62] 0 0
Poland
State/province [62] 0 0
Gdynia
Country [63] 0 0
Poland
State/province [63] 0 0
Lublin
Country [64] 0 0
Poland
State/province [64] 0 0
Olsztyn
Country [65] 0 0
Poland
State/province [65] 0 0
Warszawa
Country [66] 0 0
Romania
State/province [66] 0 0
Cluj
Country [67] 0 0
Romania
State/province [67] 0 0
Dolj
Country [68] 0 0
Romania
State/province [68] 0 0
Jud. Dolj
Country [69] 0 0
Romania
State/province [69] 0 0
Timis
Country [70] 0 0
Romania
State/province [70] 0 0
Craiova
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Arkhangelsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Saint Petersburg
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Saint-Petersburg
Country [74] 0 0
Spain
State/province [74] 0 0
Andalucia
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
A Coruna
Country [77] 0 0
Spain
State/province [77] 0 0
Las Palmas
Country [78] 0 0
Spain
State/province [78] 0 0
Madrid
Country [79] 0 0
Spain
State/province [79] 0 0
Malaga
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Switzerland
State/province [81] 0 0
Basel
Country [82] 0 0
Switzerland
State/province [82] 0 0
St. Gallen
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Cleveland
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Greater London
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Lancashire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04623775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04623775