Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-5947 | Other Identifier | WHO | |
| 2023-504515-33-00 | Other Identifier | EU CTR |
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 patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Metastatic Melanoma | Experimental |
| |
| Cohort 2: Resected Melanoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relatlimab+nivolumab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose | PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported. | Cycle 4 Day 1 (each cycle consist of 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Deaths | An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes. |
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 - 0007 | Anchorage | Alaska | 99508-2974 | United States | ||
| Local Institution - 0013 |
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
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Metastatic Melanoma | Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration. |
| 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 | May 24, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| relatlimab+nivolumab+rHuPH20 | Drug | Specified dose on specified days |
|
| nivolumab | Drug | Specified dose on specified days |
|
|
| nivolumab+rHuPH20 | Drug | Specified dose on specified days |
|
|
| First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months) |
| Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event | From first dose (Day 1) and up to study completion (up to approximately 45 months) |
| Phoenix |
| Arizona |
| 85054-4502 |
| United States |
| Local Institution - 0010 | San Francisco | California | 94115-3010 | United States |
| Local Institution - 0034 | Atlanta | Georgia | 30342 | United States |
| Local Institution - 0032 | Edgewood | Kentucky | 41017 | United States |
| Local Institution - 0028 | Albuquerque | New Mexico | 87106 | United States |
| Local Institution - 0037 | Edmonds | Washington | 98026-8032 | United States |
| Local Institution - 0036 | Issaquah | Washington | 98026 | United States |
| Local Institution - 0030 | Seattle | Washington | 98104 | United States |
| Local Institution - 0015 | Las Condes | Santiago Metropolitan | 8331010 | Chile |
| Local Institution - 0005 | Concepción | 4070196 | Chile |
| Local Institution - 0019 | Thessaloniki | B | 546 22 | Greece |
| Local Institution - 0014 | Athens | I | 115 27 | Greece |
| Local Institution - 0029 | Marousi | I | 151 25 | Greece |
| Local Institution - 0023 | Holargos, Athens | 155 62 | Greece |
| Local Institution - 0008 | Piraeus | 185 47 | Greece |
| Local Institution - 0033 | Thessaloniki | 564 29 | Greece |
| Local Institution - 0017 | Bergamo | BG | 24127 | Italy |
| Local Institution - 0035 | Meldola | FC | 47014 | Italy |
| Local Institution - 0018 | Milan | MI | 20141 | Italy |
| Local Institution - 0012 | Padova | PD | 35128 | Italy |
| Local Institution - 0021 | Roma | RM | 00144 | Italy |
| Local Institution - 0004 | Torino | TO | 10126 | Italy |
| Local Institution - 0026 | Naples | 80131 | Italy |
| Local Institution - 0011 | Barcelona | B | 08025 | Spain |
| Local Institution - 0022 | Barcelona | B | 08908 | Spain |
| Local Institution - 0009 | Cartagena | MU | 30120 | Spain |
| Local Institution - 0020 | Badalona | 08916 | Spain |
| Local Institution - 0027 | Cantabria | 39008 | Spain |
| Local Institution - 0003 | San Pedro Alcántara, Málaga | 10002 | Spain |
| Local Institution - 0006 | Seville | 41013 | Spain |
| FG001 | Cohort 2: Resected Melanoma | Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Metastatic Melanoma | Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration. |
| BG001 | Cohort 2: Resected Melanoma | Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration. |
| 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, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose | PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported. | PEPQ Evaluable population is defined as all enrolled participants who have received two doses of nivolumab + relatlimab FDC IV, two doses of nivolumab + relatlimab FDC SC and have answered Question 7 of the PEPQ | Posted | Number | 95% Confidence Interval | percentage of partcipants | Cycle 4 Day 1 (each cycle consist of 4 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events and Deaths | An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes. | All treated subjects | Posted | Count of Participants | Participants | First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event | Not Posted | Aug 2028 | From first dose (Day 1) and up to study completion (up to approximately 45 months) | Participants |
AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
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 | Cohort 1: Metastatic Melanoma | Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks until disease progression, unacceptable toxicity or up to 2 years total treatment duration. | 8 | 50 | 21 | 50 | 44 | 50 |
| EG001 | Cohort 2: Resected Melanoma | Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration. | 2 | 50 | 6 | 50 | 41 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Infected metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | 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 | Please email | Clinical.Trials@bms.com |
| Mar 31, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D057240 | Patient Preference |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729737 | Opdualag |
| 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
| Title | Measurements |
|---|---|
|
| Male |
|
| NOT HISPANIC OR LATINO |
|
| NOT REPORTED |
|
| Asian |
|
| Not reported |
|
|
|