Melanoma Clinical Trial
— RELATIVITY-047Official title:
A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
| Verified date | September 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.
| Status | Active, not recruiting |
| Enrollment | 714 |
| Est. completion date | December 16, 2025 |
| Est. primary completion date | January 25, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system - Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma - Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses Exclusion Criteria: - Participants must not have active brain metastases or leptomeningeal metastases - Participants must not have uveal melanoma - Participants must not have an active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0004 | Buenos Aires | |
| Argentina | Local Institution - 0005 | Buenos Aires | |
| Argentina | Local Institution - 0135 | Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0002 | Capital Federal | Distrito Federal |
| Argentina | Local Institution - 0003 | Ciudad Autónoma De Buenos Aires | |
| Australia | Local Institution - 0133 | Bedford Park | South Australia |
| Australia | Local Institution - 0041 | Greenslopes | Queensland |
| Australia | Local Institution - 0044 | Murdoch | Western Australia |
| Australia | Local Institution - 0042 | North Sydney | New South Wales |
| Australia | Local Institution - 0045 | Southport | Queensland |
| Australia | Local Institution - 0043 | Waratah | New South Wales |
| Austria | Local Institution - 0036 | Graz | |
| Austria | Local Institution - 0037 | Salzburg | |
| Austria | Local Institution - 0035 | Wien | |
| Belgium | Local Institution - 0047 | Brussels | |
| Belgium | Local Institution - 0049 | Bruxelles | |
| Belgium | Local Institution - 0048 | Gent | |
| Brazil | Local Institution - 0058 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0057 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0061 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0059 | Rio De Janiro | |
| Brazil | Local Institution - 0073 | Santa Cruz do Sul | RIO Grande DO SUL |
| Brazil | Local Institution - 0060 | Sao Paulo | |
| Brazil | Local Institution - 0062 | Sao Paulo | |
| Brazil | Local Institution - 0063 | São Paulo | SAO Paulo |
| Canada | Local Institution - 0124 | Halifax | Nova Scotia |
| Canada | Local Institution - 0075 | Montreal | Quebec |
| Canada | Local Institution - 0123 | Montreal | Quebec |
| Canada | Local Institution - 0068 | Ottawa | Ontario |
| Canada | Local Institution - 0128 | Toronto | Ontario |
| Chile | Local Institution - 0001 | Santiago | Metropolitana |
| Colombia | Local Institution - 0095 | Bogota | |
| Colombia | Local Institution - 0096 | Medellín | Antioquia |
| Denmark | Local Institution - 0105 | Aarhus N | |
| Denmark | Local Institution - 0103 | Herlev | |
| Denmark | Local Institution - 0104 | Odense | |
| Finland | Local Institution - 0100 | Helsinki | Uusimaa |
| Finland | Local Institution - 0102 | Oulu | |
| Finland | Local Institution - 0119 | Tampere | |
| Finland | Local Institution - 0101 | Turku | |
| France | Local Institution - 0079 | Amiens | Somme |
| France | Local Institution - 0080 | Bordeaux Cedex | |
| France | Local Institution - 0085 | Lille | |
| France | Local Institution - 0081 | Marseille | |
| France | Local Institution - 0083 | Paris | |
| France | Local Institution - 0078 | Pierre-Benite | |
| France | Local Institution - 0082 | Poitiers | |
| France | Local Institution - 0084 | Rennes | Ille-et-Vilaine |
| Germany | Local Institution - 0032 | Buxtehude | |
| Germany | Local Institution - 0030 | Erfurt | |
| Germany | Local Institution - 0027 | Essen | |
| Germany | Local Institution - 0033 | Hannover | |
| Germany | Local Institution - 0132 | Heidelberg | |
| Germany | Local Institution - 0074 | Homburg / Saar | |
| Germany | Local Institution - 0029 | Köln | |
| Germany | Local Institution - 0028 | Lubeck | |
| Germany | Local Institution - 0072 | Mannheim | |
| Germany | Local Institution - 0034 | Muenchen | |
| Germany | Local Institution - 0071 | Quedlinburg | Sachsen-Anhalt |
| Germany | Local Institution - 0131 | Tübingen | Baden-Württemberg |
| Germany | Local Institution - 0031 | Wuerzburg | |
| Greece | Local Institution - 0064 | Athens | |
| Greece | Local Institution - 0065 | Thessaloniki | |
| Israel | Local Institution - 0086 | Haifa | |
| Israel | Local Institution - 0088 | Jerusalem | |
| Israel | Local Institution - 0087 | Ramat-gan | |
| Italy | ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | |
| Italy | Local Institution - 0108 | Milano | |
| Italy | Istituto Nazionale Tumori Fondazione Pascale | Napoli | |
| Italy | Istituto Oncologico Veneto IOV | Padova | |
| Italy | AOUS - Policlinico S.Maria Alle Scotte | Siena | |
| Italy | Local Institution - 0111 | Torino | Piemonte |
| Mexico | Local Institution - 0093 | Cancún | Quintana Roo |
| Mexico | Local Institution - 0092 | Merida | Yucatan |
| Mexico | Local Institution - 0091 | Monterrey | Nuevo LEON |
| Mexico | Local Institution - 0129 | Veracruz | |
| Mexico | Local Institution - 0094 | Zapopan | Jalisco |
| New Zealand | Local Institution - 0090 | Dunedin | |
| New Zealand | Local Institution - 0125 | Hamilton | |
| New Zealand | Local Institution - 0089 | Tauranga | |
| Norway | Local Institution - 0121 | Oslo | |
| Poland | Local Institution - 0040 | Poznan | Wielkopolskie |
| Poland | Local Institution - 0039 | Warszawa | |
| Romania | Local Institution - 0066 | Bucharest | |
| Romania | Local Institution - 0070 | Cluj-Napoca | Cluj |
| Romania | Local Institution - 0067 | Craiova | |
| Romania | Local Institution - 0069 | Iasi | |
| Russian Federation | Local Institution - 0113 | Krasnodar | |
| Russian Federation | Local Institution - 0127 | Krasnoyarsk | |
| Russian Federation | Local Institution - 0112 | Moscow | |
| Spain | Local Institution - 0023 | A Coruña | |
| Spain | Local Institution - 0024 | Barcelona | |
| Spain | Local Institution - 0025 | Barcelona | |
| Spain | Local Institution - 0026 | Madrid | |
| Spain | Local Institution - 0021 | San Sabastian Gipuzkoa | |
| Spain | Local Institution - 0022 | Sevilla | |
| Sweden | Local Institution - 0098 | Goteborg | |
| Sweden | Local Institution - 0099 | Lund | |
| Sweden | Local Institution - 0118 | Solna | |
| Sweden | Local Institution - 0122 | Uppsala | |
| United Kingdom | Local Institution - 0052 | Bristol | Avon |
| United Kingdom | Local Institution - 0054 | Glasgow | Dumfries & Galloway |
| United Kingdom | Local Institution - 0126 | Inverness | Inverness-shire |
| United Kingdom | Local Institution - 0051 | London | Greater London |
| United Kingdom | Local Institution - 0056 | Swansea | Glamorgan |
| United States | Local Institution - 0019 | Allentown | Pennsylvania |
| United States | Local Institution - 0015 | Ann Arbor | Michigan |
| United States | Local Institution - 0038 | Atlanta | Georgia |
| United States | Local Institution - 0077 | Baltimore | Maryland |
| United States | Local Institution - 0120 | Baltimore | Maryland |
| United States | Local Institution - 0014 | Boston | Massachusetts |
| United States | Local Institution - 0134 | Boston | Massachusetts |
| United States | Local Institution - 0018 | Charlotte | North Carolina |
| United States | Local Institution - 0016 | Chicago | Illinois |
| United States | Local Institution - 0076 | Dallas | Texas |
| United States | Local Institution - 0114 | Fort Wayne | Indiana |
| United States | Local Institution - 0008 | Houston | Texas |
| United States | Local Institution - 0013 | Jacksonville | Florida |
| United States | Local Institution - 0020 | Los Angeles | California |
| United States | Local Institution - 0009 | Minneapolis | Minnesota |
| United States | Local Institution - 0117 | Orlando | Florida |
| United States | Local Institution - 0011 | Rochester | Minnesota |
| United States | Coastal Integrative Cancer Care | San Luis Obispo | California |
| United States | Local Institution - 0116 | Santa Barbara | California |
| United States | Local Institution - 0007 | Tampa | Florida |
| United States | Local Institution - 0010 | Tucson | Arizona |
| United States | Local Institution - 0012 | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The Number of Participants Experiencing Adverse Events (AEs) | The number of participants experiencing adverse events (AEs).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | |
| Other | The Number of Participants Experiencing Serious Adverse Events (SAEs) | The number of participants experiencing serious adverse events (SAEs).
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, is an important medical event. |
From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | |
| Other | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | The number of participants experiencing adverse events (AEs) leading to discontinuation.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | |
| Other | The Number of Participant Deaths in the Study | The number of participant deaths in the study. | From first dose up to approximately 33 months | |
| Other | The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units. | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | |
| Other | The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units. | From first dose to 30 days after last dose of study therapy (up to approximately 33 months) | |
| Primary | Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death. | From randomization to date of first documented tumor progression or death (up to approximately 33 months) | |
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). | From randomization to the date of death (up to approximately 3 years) | |
| Secondary | Overall Response Rate (ORR) | Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria). | From randomization up to approximately 3 years |
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