Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001863-10 | EudraCT Number | ||
| U1111-1250-4427 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 | Experimental |
| |
| Arm B: Carboplatin + Etoposide + Nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986012 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
| Number of Participants With Serious Adverse Events | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
| Number of Participants With Adverse Events Leading to Discontinuation | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
| Number of Participants Who Died | Number of participants who died due to any cause. | From first dose to primary cutoff date (Up to approximately 43 months) |
| Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate (PFSR) at 6 and 12 Months | PFSR is defined as the percentage of participants progression free at 6 and 12 months. PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Blinded Independent Central Review (BICR) and by investigator, or death from any cause. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0075 | Birmingham | Alabama | 35249 | United States | ||
| Local Institution - 0022 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36275912 | Derived | Chu Q, Leighl NB, Surmont V, van Herpen C, Sibille A, Markman B, Clarke S, Juergens RA, Rivera MA, Andelkovic V, Rudin CM, Snow S, Kim DW, Sanatani M, Lin H, Sanghavi K, Tannenbaum-Dvir S, Basciano P, Lathers D, Urbanska K, Kollia G, He C, DiPiero A, Liu Y, Ready N. BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study. JTO Clin Res Rep. 2022 Aug 27;3(11):100400. doi: 10.1016/j.jtocrr.2022.100400. eCollection 2022 Nov. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-treatment |
|
Not provided
Not provided
Not provided
| 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 | Mar 22, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin | Drug | Specified dose on specified days |
|
| Etoposide | Drug | Specified dose on specified days |
|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months) |
| 6 and 12 months |
| Progression Free Survival (PFS) Per Investigator | PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Investigator or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. | From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months) |
| Objective Response Rate (ORR) | ORR per Blinded Independent Central Review (BICR) and per investigator is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | From randomization to the date of first documented response (Up to approximately 56 months) |
| Duration of Response (DoR) | DoR per Blinded Independent Central Review and per investigator is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months) |
| Time to Response (TTR) | TTR per Blinded Independent Central Review (BICR) and per investigator is defined for participants who had a confirmed CR or PR as the time from the date of randomization to date of first documented CR or PR per RECIST v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | From randomization to the date of first documented CR or PR (Up to approximately 56 months) |
| Overall Survival (OS) | OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method. | From randomization to the date of death due to any cause (Up to approximately 56 months) |
| Overall Survival Rate (OSR) at 12 and 24 Months | OSR is defined as the percentage of participants surviving at 12 and 24 months. OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method. | 12 and 24 months |
| Number of Participants With Anti-Nivolumab Antibody (ADA) | ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. Baseline ADA Positive: A participant with baseline ADA-positive sample. | From baseline up to approximately 56 months |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Local Institution - 0002 | Durham | North Carolina | 27710 | United States |
| Local Institution - 0060 | Cincinnati | Ohio | 45267 | United States |
| Local Institution | Cincinnati | Ohio | 45267 | United States |
| Local Institution - 0067 | Cleveland | Ohio | 44106-1716 | United States |
| Local Institution - 0081 | Nashville | Tennessee | 37203 | United States |
| Local Institution | Dallas | Texas | 75390 | United States |
| Local Institution - 0003 | Westmead | New South Wales | 2145 | Australia |
| Local Institution - 0023 | Greenslopes | Queensland | 4120 | Australia |
| Local Institution - 0001 | Malvern | Victoria | 3144 | Australia |
| Local Institution - 0004 | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 0051 | Charleroi | Hainaut | 6060 | Belgium |
| Local Institution - 0034 | Ghent | 9000 | Belgium |
| Local Institution - 0050 | Liège | 4000 | Belgium |
| Local Institution - 0012 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0064 | Brampton | Ontario | L6R 3J7 | Canada |
| Local Institution - 0045 | Heraklion | IrakleÃo | 715 00 | Greece |
| Local Institution - 0036 | Athens | 11527 | Greece |
| Local Institution - 0038 | Athens | 185 47 | Greece |
| Local Institution - 0030 | Peschiera del Garda | 37019 | Italy |
| Local Institution - 0031 | Pisa | 56124 | Italy |
| Local Institution - 0029 | Rozzano | 20089 | Italy |
| Local Institution - 0073 | Sendai | Miyagi | 980-0873 | Japan |
| Local Institution - 0070 | ÅŒsaka-sayama | Osaka | 589-8511 | Japan |
| Local Institution - 0069 | Takatsuki | Osaka | 5698686 | Japan |
| Local Institution - 0077 | Ina-machi | Saitama | 362-0806 | Japan |
| Local Institution - 0039 | Amsterdam | North Holland | 1081 HV | Netherlands |
| Local Institution - 0066 | Arnhem | 6815 AD | Netherlands |
| Local Institution - 0040 | Groningen | 9700RB | Netherlands |
| Local Institution - 0049 | Gdansk | 80-214 | Poland |
| Local Institution - 0048 | Lodz | 93-338 | Poland |
| Local Institution - 0043 | Bucharest | 022328 | Romania |
| Local Institution - 0042 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0041 | Craiova | 200542 | Romania |
| Local Institution - 0007 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Local Institution - 0021 | Madrid | 28041 | Spain |
| Local Institution - 0005 | Majadahonda | 28222 | Spain |
| Local Institution - 0006 | Málaga | 29010 | Spain |
| BMS Clinical Trial Patient Recruiting | View source |
| Arm B |
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment - Induction Phase |
|
|
| Treatment - Maintenance Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle) |
| BG001 | Arm B | Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle) |
| BG002 | 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Progression Free Survival Rate (PFSR) at 6 and 12 Months | PFSR is defined as the percentage of participants progression free at 6 and 12 months. PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Blinded Independent Central Review (BICR) and by investigator, or death from any cause. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 and 12 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per Investigator | PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Investigator or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR per Blinded Independent Central Review (BICR) and per investigator is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to the date of first documented response (Up to approximately 56 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DoR per Blinded Independent Central Review and per investigator is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | All responders (CR+PR) per BICR and per Investigator | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR per Blinded Independent Central Review (BICR) and per investigator is defined for participants who had a confirmed CR or PR as the time from the date of randomization to date of first documented CR or PR per RECIST v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions. | All responders (CR+PR) per BICR and per Investigator | Posted | Median | Full Range | Months | From randomization to the date of first documented CR or PR (Up to approximately 56 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Died | Number of participants who died due to any cause. | All treated participants | Posted | Count of Participants | Participants | From first dose to primary cutoff date (Up to approximately 43 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) | PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of death due to any cause (Up to approximately 56 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OSR) at 12 and 24 Months | OSR is defined as the percentage of participants surviving at 12 and 24 months. OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 and 24 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Nivolumab Antibody (ADA) | ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. Baseline ADA Positive: A participant with baseline ADA-positive sample. | All treated participants with baseline immunogenicity assessments in arm A only as pre-specified | Posted | Count of Participants | Participants | From baseline up to approximately 56 months |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Participants With Adverse Events - Extended Collection | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose (Up to approximately 47 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Participants With Serious Adverse Events - Extended Collection | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose (Up to approximately 47 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Participants With Adverse Events Leading to Discontinuation - Extended Collection | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose (Up to approximately 47 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Participants Who Died - Extended Collection | Number of participants who died due to any cause. | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days post last dose (Up to approximately 47 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) - Extended Collection | PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months) |
|
|
All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized 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 | Arm A | Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle) | 50 | 67 | 38 | 66 | 62 | 66 |
| EG001 | Arm B | Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle) | 56 | 68 | 34 | 65 | 62 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Death | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Sudden death | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dermatomyositis | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Adenomyoepithelioma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hemiplegic migraine | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Malaise | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.1 | 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 | Please Email: | Clinical.Trials@bms.com |
| May 20, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
Not provided
Not provided
| Death |
|
| Disease progression |
|
| Study drug toxicity |
|
| Adverse Event unrelated to study drug |
|
| Disease progression |
|
| Study drug toxicity |
|
| Adverse event unrelated to study drug |
|
| other reasons |
|
| Participant request to discontinue study |
|
| transitioned to rollover study |
|
| 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 |
|
| 12 months - BICR |
|
| 12 months Investigator |
|
| Participants |
|
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|