Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004026-31 | EudraCT Number | ||
| U1111-1256-8115 | Registry Identifier | WHO |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) | Experimental |
| |
| Part 2: Arm D (Nivolumab + PDCT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | from first dose to 12 weeks after first dose |
| ORR Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | Approximately 14.8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| TRAEs Leading to Discontinuation in Part 1 | Number of participants with treatment related adverse events (TRAEs) leading to discontinuation based on grade. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 |
Not provided
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0160 | Duarte | California | 91010 | United States | ||
| Local Institution - 0081 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
468 Randomized and 463 Treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Treatment A | Nivo 360mg Q3W + Rela 720mg Q3W + Histology Based PDCT |
| FG001 | Part 1: Treatment B | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2024 |
Not provided
Not provided
Not provided
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Not provided
| Relatlimab | Biological | Specified dose on specified days |
|
| Carboplatin | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| Cisplatin | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| Paclitaxel | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| Nab-Paclitaxel | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| Pemetrexed | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
| Number of Participants With a Treatment Related AEs in Part 1 | Number of participants with a treatment related AE in part 1. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
| Number of Participants With Treatment Releted SAEs in Part 1 | A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition). Grading will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
| Number of Participants With Treatment Releted Select AEs in Part 1 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
| ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | Approximately 14.8 Months |
| DoR Per RECISTS v1.1 by BICR in Part 2 | Duration of Response (DOR) will be assessed by BICR. It is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR (per RECIST v1.1), or death due to any cause, whichever occurs first. | Approximately up to 13.7 months |
| Number of Participants With a AE in Part 2 | Number of participants with an adverse event (AE). AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
| Number of Participants With a Treatment Related AEs in Part 2 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
| Number of Participants With a Treatment Related SAEs in Part 2 | SAE is defined as a life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). SAEs can also result in death. The AE requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Is an important medical event (defined as a medical event(s) that may not be immediately lifethreatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Grading will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
| Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2 | IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. Grading will be determined for severity according to the NCI CTCAE v5.0. | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
| ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | On Going |
| ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | Ongoing |
| PFS Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Ongoing |
| PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Ongoing |
| PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Ongoing |
| PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Ongoing |
| Number of Participants With Treatment Releted Select AEs in Part 2 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0. | Ongoing |
| Orange |
| California |
| 92868 |
| United States |
| Local Institution - 0139 | New Haven | Connecticut | 06520 | United States |
| Local Institution - 0153 | Jacksonville | Florida | 32204 | United States |
| Local Institution - 0011 | Port Saint Lucie | Florida | 34952 | United States |
| Local Institution - 0089 | Athens | Georgia | 30607 | United States |
| Local Institution - 0121 | Wichita | Kansas | 67214 | United States |
| Local Institution - 0159 | Lexington | Kentucky | 40503 | United States |
| Local Institution - 0002 | Louisville | Kentucky | 40241 | United States |
| Local Institution - 0082 | Scarborough | Maine | 04074 | United States |
| Local Institution - 0129 | Omaha | Nebraska | 68130 | United States |
| Local Institution - 0152 | Howell Township | New Jersey | 07731 | United States |
| Local Institution - 0124 | Johnson City | New York | 13790 | United States |
| Local Institution - 0162 | Mineola | New York | 11501 | United States |
| Local Institution - 0128 | New York | New York | 10016 | United States |
| Local Institution - 0165 | New York | New York | 10021 | United States |
| Local Institution - 0097 | The Bronx | New York | 10461 | United States |
| Local Institution - 0117 | Durham | North Carolina | 27710 | United States |
| Local Institution - 0156 | Cincinnati | Ohio | 45219 | United States |
| Local Institution - 0155 | Cleveland | Ohio | 44109 | United States |
| Local Institution - 0084 | Lancaster | Pennsylvania | 17604 | United States |
| Local Institution - 0147 | Pittsburgh | Pennsylvania | 15212 | United States |
| Local Institution - 0148 | Providence | Rhode Island | 02903 | United States |
| Local Institution - 0083 | Greenville | South Carolina | 29607 | United States |
| Local Institution - 0149 | Dallas | Texas | 75390-9179 | United States |
| Local Institution - 0091 | Harlingen | Texas | 78550 | United States |
| Local Institution - 0001 | Tyler | Texas | 75701 | United States |
| Local Institution - 0092 | Spokane | Washington | 99208 | United States |
| Local Institution - 0157 | Morgantown | West Virginia | 26506 | United States |
| Local Institution - 0037 | RÃo Cuarto | Córdoba Province | 5800 | Argentina |
| Local Institution - 0021 | Buenos Aires | Distrito Federal | C1426 | Argentina |
| Local Institution - 0014 | Cuiudad Autonoma de Buenos Aires | Distrito Federal | C1430EGF | Argentina |
| Local Institution - 0039 | Viedma | RÃo Negro Province | 8500 | Argentina |
| Local Institution - 0029 | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution - 0060 | Córdoba | 5006 | Argentina |
| Local Institution - 0038 | Córdoba | X5004FHP | Argentina |
| Local Institution - 0073 | La Rioja | F5300COE | Argentina |
| Local Institution - 0055 | Camperdown | New South Wales | 2050 | Australia |
| Local Institution - 0086 | Gosford | New South Wales | 2250 | Australia |
| Local Institution - 0132 | Tamworth | New South Wales | 2340 | Australia |
| Local Institution - 0057 | Adelaide | South Australia | 5087 | Australia |
| Local Institution - 0130 | Ballarat | Victoria | 3350 | Australia |
| Local Institution - 0138 | Bendigo | Victoria | 3550 | Australia |
| Local Institution - 0141 | Box Hill | Victoria | 3128 | Australia |
| Local Institution - 0109 | Frankston | Victoria | 3199 | Australia |
| Local Institution - 0119 | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 0085 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0090 | Graz | 8036 | Austria |
| Local Institution - 0126 | Vienna | 1090 | Austria |
| Local Institution - 0127 | Ghent | 9000 | Belgium |
| Local Institution - 0131 | Ghent | 9000 | Belgium |
| Local Institution - 0125 | Roeselare | 8800 | Belgium |
| Local Institution - 0063 | Natal | Rio Grande do Norte | 59062 000 | Brazil |
| Local Institution - 0161 | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution - 0116 | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Local Institution - 0112 | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Local Institution - 0107 | Barretos | São Paulo | 14784-400 | Brazil |
| Local Institution - 0111 | Santo André | São Paulo | 09060-870 | Brazil |
| Local Institution - 0072 | Rio de Janeiro | 20220-410 | Brazil |
| Local Institution - 0163 | São Paulo | 04014-002 | Brazil |
| Local Institution - 0120 | São Paulo | 08270-120 | Brazil |
| Local Institution - 0079 | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0041 | Santiago | Santiago Metropolitan | 7500713 | Chile |
| Local Institution - 0016 | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 0008 | Rennes | Ille-Et-Vilaine | 35000 | France |
| Local Institution - 0007 | Dijon | 21 000 | France |
| Local Institution - 0144 | Le Mans | 72037 | France |
| Local Institution - 0102 | Paris | 75014 | France |
| Local Institution - 0035 | Paris | 75018 | France |
| Local Institution - 0006 | Saint-Mandé | 94160 | France |
| Local Institution - 0110 | Paris | ÃŽle-de-France Region | 75005 | France |
| Local Institution - 0065 | Essen | North Rhine-Westphalia | 45136 | Germany |
| Local Institution - 0103 | Berlin | 12351 | Germany |
| Local Institution - 0045 | Berlin | 13585 | Germany |
| Local Institution - 0062 | Großhansdorf | 22927 | Germany |
| Local Institution - 0058 | Homburg | 66421 | Germany |
| Local Institution - 0108 | Löwenstein | 74245 | Germany |
| Local Institution - 0071 | Marburg | 35043 | Germany |
| Local Institution - 0050 | Paderborn | 33098 | Germany |
| Local Institution - 0030 | Ravensburg | 88212 | Germany |
| Local Institution - 0133 | Elm Park | Dublin | 4 | Ireland |
| Local Institution - 0023 | Dublin | 00009 | Ireland |
| Local Institution - 0106 | Rome | RA | 00144 | Italy |
| Local Institution - 0028 | Candiolo | 10060 | Italy |
| Local Institution - 0009 | Catania | 95125 | Italy |
| Local Institution - 0032 | Genova | 16149 | Italy |
| Local Institution - 0059 | Milan | 20141 | Italy |
| Local Institution - 0164 | Pesaro | 61122 | Italy |
| Local Institution - 0019 | Siena | 53100 | Italy |
| Local Institution - 0070 | Mexico City | Mexico City | 14050 | Mexico |
| Local Institution - 0115 | Monterrey | Nuevo León | 64710 | Mexico |
| Local Institution - 0013 | San Pedro Garza GarcÃa | Nuevo León | 66220 | Mexico |
| Local Institution - 0020 | Toluca | State of Mexico | 50090 | Mexico |
| Local Institution - 0053 | Harderwijk | Gelderland | 3844 | Netherlands |
| Local Institution - 0158 | Arnhem | 6815 | Netherlands |
| Local Institution - 0145 | Gdynia | 81-519 | Poland |
| Local Institution - 0036 | Lublin | 20-090 | Poland |
| Local Institution - 0031 | Lublin | 20-093 | Poland |
| Local Institution - 0080 | Olsztyn | 10-357 | Poland |
| Local Institution - 0088 | Warsaw | 02-781 | Poland |
| Local Institution - 0099 | Cluj-Napoca | Cluj | 400015 | Romania |
| Local Institution - 0017 | Craiova | Dolj | 200385 | Romania |
| Local Institution - 0012 | Craiova | Jud. Dolj | 200094 | Romania |
| Local Institution - 0069 | Timișoara | Timiș County | 300166 | Romania |
| Local Institution - 0052 | Craiova | 200347 | Romania |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | 163045 | Russia |
| LLC Eurocityclinic | Saint Petersburg | 197022 | Russia |
| FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus | Saint Petersburg | 197376 | Russia |
| Local Institution - 0075 | Seville | Andalusia | 41013 | Spain |
| Local Institution - 0137 | Badalona | Barcelona | 08916 | Spain |
| Local Institution - 0024 | Barcelona | Catalonia | 08008 | Spain |
| Local Institution - 0051 | A Coruña | 15006 | Spain |
| Local Institution - 0154 | Barcelona | 08025 | Spain |
| Local Institution - 0048 | Barcelona | 08035 | Spain |
| Local Institution - 0061 | Las Palmas | 35016 | Spain |
| Local Institution - 0074 | Madrid | 28041 | Spain |
| Local Institution - 0123 | Madrid | 28046 | Spain |
| Local Institution - 0042 | Málaga | 29011 | Spain |
| Local Institution - 0043 | Valencia | 46026 | Spain |
| Local Institution - 0015 | Basel | 4031 | Switzerland |
| Local Institution - 0104 | Sankt Gallen | 9007 | Switzerland |
| Local Institution - 0135 | Middlesbrough | Cleveland | TS4 3BW | United Kingdom |
| Local Institution - 0101 | London | Greater London | NW1 2PG | United Kingdom |
| Local Institution - 0095 | Manchester | Lancashire | M20 4BX | United Kingdom |
| Local Institution - 0067 | Leicester | LE15WW | United Kingdom |
| FG002 | Part 2: Treatment C | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT |
| FG003 | Part 2: Treatment D | Nivo 360mg Q3W + Histology Based PDCT |
| COMPLETED | Completed = Will Receive Treatment |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Treatment A | Nivo 360mg Q3W + Rela 720mg Q3W + Histology Based PDCT |
| BG001 | Part 1: Treatment B | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT |
| BG002 | Part 2: Treatment C | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT |
| BG003 | Part 2: Treatment D | Nivo 360mg Q3W + Histology Based PDCT |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | All Treated Dose-Safety Evaluable participants in part 1 | Posted | Number | 95% Confidence Interval | Percentage of Participants | from first dose to 12 weeks after first dose |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | ORR Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | All randomized participants in Part 2 | Posted | Number | 90% Confidence Interval | Percentage of Participants | Approximately 14.8 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TRAEs Leading to Discontinuation in Part 1 | Number of participants with treatment related adverse events (TRAEs) leading to discontinuation based on grade. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 | All treated participants in Part 1 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Treatment Related AEs in Part 1 | Number of participants with a treatment related AE in part 1. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 | All treated participants in Part 1 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Releted SAEs in Part 1 | A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition). Grading will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 1 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Releted Select AEs in Part 1 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 1 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | All randomized participants in Part 2 | Posted | Number | 90% Confidence Interval | Percentage of Participants | Approximately 14.8 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DoR Per RECISTS v1.1 by BICR in Part 2 | Duration of Response (DOR) will be assessed by BICR. It is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR (per RECIST v1.1), or death due to any cause, whichever occurs first. | All randomized participants in Part 2 | Posted | Median | 90% Confidence Interval | Months | Approximately up to 13.7 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a AE in Part 2 | Number of participants with an adverse event (AE). AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Treatment Related AEs in Part 2 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Treatment Related SAEs in Part 2 | SAE is defined as a life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). SAEs can also result in death. The AE requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Is an important medical event (defined as a medical event(s) that may not be immediately lifethreatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Grading will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2 | IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. Grading will be determined for severity according to the NCI CTCAE v5.0. | All treated participants in Part 2 | Posted | Count of Participants | Participants | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | Not Posted | Jan 2027 | On Going | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. | Not Posted | Jan 2027 | Ongoing | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Not Posted | Jan 2027 | Ongoing | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Not Posted | Jan 2027 | Ongoing | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Not Posted | Jan 2027 | Ongoing | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first. | Not Posted | Jan 2027 | Ongoing | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Releted Select AEs in Part 2 | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0. | Not Posted | Jan 2027 | Ongoing | Participants |
All-Cause mortality, Adverse Events and Serious Adverse Events: (From first dose to last dose + 135 days): Approximately 36 Months
The number at Risk for All-Cause Mortality represents all Treated Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Treatment A | Nivo 360mg Q3W + Rela 720mg Q3W + Histology Based PDCT | 47 | 77 | 46 | 77 | 74 | 77 |
| EG001 | Part 1: Treatment B | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT | 46 | 79 | 52 | 79 | 78 | 79 |
| EG002 | Part 2: Treatment C | Nivo 360mg Q3W + Rela 360mg Q3W + Histology Based PDCT | 79 | 158 | 103 | 158 | 151 | 158 |
| EG003 | Part 2: Treatment D | Nivo 360mg Q3W + Histology Based PDCT | 70 | 149 | 81 | 149 | 145 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Suspected drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Adenovirus test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral cyst | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | 1-855-907-3286 | Clinical.Trials@bms.com |
| Feb 27, 2025 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000721227 | relatlimab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| poor/non compliance |
|
| participant no longer meets study criteria |
|
| administrative reasons by sponsor |
|
| other reasons |
|
| disease progression |
|
| study drug toxicity |
|
| AE unrelated to study drug |
|
| participant request to discontinue treatment |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|