Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503715-14 | Other Identifier | EU CTR | |
| U1111-1264-4062 | 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
The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relatlimab + Nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relatlimab | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A | Hepatic DLT
Hematologic DLT
| 1 cycle, defined as 28 days |
| Complete Metabolic Response (CMR) Rate - Part B | The CMR rate is defined as the percentage of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria. No participants enrolled in Part B. | From first dose until the first documented response |
| Number of Participants With Adverse Events (AEs) - Part A | 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 135 days post last dose (Up to approximately 11 months) |
| Number of Participants Who Died - Part A | Number of participants who died due to any cause | from first dose to 135 days post last dose (Up to approximately 11 months) |
| Number of Participants With Serious Adverse Events (SAEs) - Part A |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) - Part B | 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. No participants enrolled in part B. | From first dose to 135 days post last dose |
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 - 0077 | Birmingham | Alabama | 35233 | United States | ||
| Local Institution - 0024 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Only Part A was initiated prior to early study termination. Part B was not initiated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A - Flat Dosing (AF) | Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W |
| FG001 | Part A - Age/Weight-based Dosing (AW) | Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Aug 19, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Nivolumab | Drug | Specified Dose on Specified Days |
|
|
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 135 days post last dose (Up to approximately 11 months) |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A | 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 135 days post last dose (Up to approximately 11 months) |
| Number of Participants With Laboratory Abnormalities - Part A | Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry. Grade 3=severe Grade 4=life-threatening Grade 5=death | From first dose to 30 days post last dose (Up to approximately 8 months) |
| Maximum Serum Concentration (Cmax) | Maximum observed serum concentration of Analyte BMS-986016 | Cycle 1 Day 1 |
| Time to Maximum Concentration (Tmax) | Time of maximum observed serum concentration of Analyte BMS-986016 | Cycle 1 Day 1 |
| Area Under the Concentration-time Curve [AUC(TAU)] | Area Under the Concentration-time Curve [AUC(TAU)] for Analyte BMS-986016 | Cycle 1 Day 1 |
| Concentration Trough (Ctrough) | Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558 | Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1 |
| Number of Participants With Serious Adverse Events (SAEs) - Part B | 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. No participants enrolled in part B. | From first dose to 135 days post last dose |
| Number of Participants With Adverse Events Leading to Discontinuation - Part B | 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. No participants enrolled in part B. | From first dose to 135 days post last dose |
| Number of Participants Who Died - Part B | Number of participants who died due to any cause. No participants enrolled in part B. | From first dose to 135 days post last dose |
| Number of Participants With Laboratory Abnormalities - Part B | No participants enrolled in part B. | From first dose to 135 days post last dose |
| Objective Response Rate (ORR) - Part B | ORR is defined as the percentage of all response evaluable participants who achieve a best response of CMR or PMR using the Lugano 2014 classification. No participants enrolled in part B | From to |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Local Institution - 0035 | Palo Alto | California | 94304 | United States |
| Local Institution - 0032 | New Haven | Connecticut | 06510 | United States |
| Local Institution - 0066 | Fort Myers | Florida | 33908 | United States |
| Local Institution - 0073 | Baltimore | Maryland | 21287 | United States |
| Local Institution - 0025 | Minneapolis | Minnesota | 55454 | United States |
| Local Institution - 0020 | Jackson | Mississippi | 39216 | United States |
| Local Institution - 0071 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0060 | New York | New York | 10032 | United States |
| Local Institution - 0059 | Valhalla | New York | 10595 | United States |
| Local Institution - 0029 | Austin | Texas | 78723 | United States |
| Local Institution - 0026 | San Antonio | Texas | 78207 | United States |
| Local Institution - 0037 | Randwick | New South Wales | 2031 | Australia |
| Royal Childrens Hospital RCH - Queensland Childrens Hospital | South Brisbane | Queensland | 4101 | Australia |
| Local Institution - 0042 | Nedlands | Western Australia | 6009 | Australia |
| CHU dAngers - Pole Pediatrie | Angers | Angers Cedex 9 | 49933 | France |
| Groupe Hospitalier Pellegrin - Hopital des enfants | Bordeaux | 33076 | France |
| Local Institution - 0033 | Caen | 14033 | France |
| Local Institution - 0067 | La Tronche | 38700 | France |
| Institut d Hematologie et d Oncologie Pediatriques | Lyon | 69373 Cedex 08 | France |
| Centre Hospitalier Universitaire de Montpellier CHU Montpellier - Hopital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Armand-Trousseau | Paris | 75571 | France |
| Assistance Publique-Hopitaux de Paris AP-HP - Hopital Universitaire Robert-Debre | Paris | 75935 | France |
| CHRU de Strasbourg-Hopital de Hautepierre | Strasbourg | 67000 | France |
| Fondazione IRCCS Istituto Nazionale Dei Tumori | Milan | Milano | 20133 | Italy |
| Local Institution - 0010 | Aviano | 33081 | Italy |
| Azienda Ospedaliero Universitaria di Bologna | Bologna | 40138 | Italy |
| Local Institution - 0040 | Florence | 50139 | Italy |
| Local Institution - 0070 | Milan | 20162 | Italy |
| Fondazione MBBM - Clinica Pediatrica | Monza | 20900 | Italy |
| Azienda Ospedale Universita Padova | Padova | 35128 | Italy |
| Local Institution - 0041 | Pavia | 27100 | Italy |
| Local Institution - 0002 | Roma | 00165 | Italy |
| Local Institution - 0004 | Turin | 10126 | Italy |
| Princess Maxima Center for pediatric oncology | Utrecht | 3584 CS | Netherlands |
| Local Institution - 0069 | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Local Institution - 0030 | Madrid | Madrid | 28009 | Spain |
| Local Institution - 0046 | Barcelona | 08035 | Spain |
| Local Institution - 0058 | Madrid | 28027 | Spain |
| Local Institution - 0044 | Madrid | 28040 | Spain |
| Local Institution - 0055 | Madrid | 28041 | Spain |
| Local Institution - 0045 | Madrid | 28046 | Spain |
| Local Institution - 0062 | Pamplona | 31008 | Spain |
| Local Institution - 0023 | Seville | 41013 | Spain |
| Local Institution - 0049 | Valencia | 46026 | Spain |
| Local Institution - 0075 | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Local Institution - 0074 | Liverpool | England | L12 2AP | United Kingdom |
| Local Institution - 0054 | London | Londonderry | NW1 2PG | United Kingdom |
| Local Institution - 0068 | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| Local Institution - 0053 | London | SM2 5PT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A - Flat Dosing (AF) | Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W |
| BG001 | Part A - Age/Weight-based Dosing (AW) | Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W |
| 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, 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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Adverse Events (AEs) - Part B | 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. No participants enrolled in part B. | All treated participants in part B | Posted | Count of Participants | Participants | From first dose to 135 days post last dose |
|
| ||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) - Part B | 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. No participants enrolled in part B. | All treated participants in part B | Posted | Count of Participants | Participants | From first dose to 135 days post last dose |
|
| ||||||||||||||||||
| Secondary | Number of Participants With Adverse Events Leading to Discontinuation - Part B | 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. No participants enrolled in part B. | All treated participants in part B | Posted | Count of Participants | Participants | From first dose to 135 days post last dose |
|
| ||||||||||||||||||
| Secondary | Number of Participants Who Died - Part B | Number of participants who died due to any cause. No participants enrolled in part B. | All treated participants in part B | Posted | Count of Participants | Participants | From first dose to 135 days post last dose |
|
| ||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities - Part B | No participants enrolled in part B. | All treated participants in part B | Posted | Count of Participants | Participants | From first dose to 135 days post last dose |
|
| ||||||||||||||||||
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A | Hepatic DLT
Hematologic DLT
| All treated participants in part A | Posted | Count of Participants | Participants | 1 cycle, defined as 28 days |
| |||||||||||||||||||
| Primary | Complete Metabolic Response (CMR) Rate - Part B | The CMR rate is defined as the percentage of all response-evaluable participants who achieve the best response of CMR using Lugano 2014 criteria. No participants enrolled in Part B. | all response-evaluable participants in Part B | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose until the first documented response |
|
| |||||||||||||||||
| Secondary | Objective Response Rate (ORR) - Part B | ORR is defined as the percentage of all response evaluable participants who achieve a best response of CMR or PMR using the Lugano 2014 classification. No participants enrolled in part B | All treated participants in part B | Posted | Number | 95% Confidence Interval | Percentage of participants | From to |
|
| |||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) - Part A | 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 in part A | Posted | Count of Participants | Participants | From first dose to 135 days post last dose (Up to approximately 11 months) |
|
| ||||||||||||||||||
| Primary | Number of Participants Who Died - Part A | Number of participants who died due to any cause | All treated participants in part A | Posted | Count of Participants | Participants | from first dose to 135 days post last dose (Up to approximately 11 months) |
|
| ||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) - Part A | 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 in part A | Posted | Count of Participants | Participants | from first dose to 135 days post last dose (Up to approximately 11 months) |
|
| ||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part A | 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 in part A | Posted | Count of Participants | Participants | From first dose to 135 days post last dose (Up to approximately 11 months) |
|
| ||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities - Part A | Number of participants with Grade ≥ 3 laboratory abnormalities in hematology and serum chemistry. Grade 3=severe Grade 4=life-threatening Grade 5=death | All treated participants in part A | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to approximately 8 months) |
|
| ||||||||||||||||||
| Primary | Maximum Serum Concentration (Cmax) | Maximum observed serum concentration of Analyte BMS-986016 | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 1 Day 1 |
|
| |||||||||||||||||
| Primary | Time to Maximum Concentration (Tmax) | Time of maximum observed serum concentration of Analyte BMS-986016 | PK Population | Posted | Median | Full Range | hour | Cycle 1 Day 1 |
|
| |||||||||||||||||
| Primary | Area Under the Concentration-time Curve [AUC(TAU)] | Area Under the Concentration-time Curve [AUC(TAU)] for Analyte BMS-986016 | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Cycle 1 Day 1 |
|
| |||||||||||||||||
| Primary | Concentration Trough (Ctrough) | Concentration Trough (Ctrough) for Analyte BMS-986016 and BMS-936558 | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1 |
|
|
All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 38 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 11 months)
Not provided
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 A - Flat Dosing (AF) | Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W | 0 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Part A - Age/Weight-based Dosing (AW) | Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W | 1 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial pain | General disorders and administration site conditions | MedDRA 28.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 28.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Chills | General disorders and administration site conditions | MedDRA 28.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | MedDRA 28.1 | Non-systematic Assessment |
| |
| Pain | General disorders and administration site conditions | MedDRA 28.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 28.1 | Non-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 |
| Jun 2, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D002051 | Burkitt Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| 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 |
Not provided
Not provided
| >=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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|