A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Launched by AMGEN · Sep 20, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ABP 206 to see how it compares to an existing medication known as OPDIVO® (Nivolumab) for patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body. The goal is to find out how effective and safe ABP 206 is for treating patients who have not received any prior treatments for their melanoma.
To participate in the trial, you must be at least 18 years old and have a confirmed diagnosis of unresectable or metastatic melanoma. You should not have received any previous systemic treatment for advanced melanoma and must have measurable disease that can be evaluated. If you qualify and decide to join, you will be monitored to see how well the treatment works and if there are any side effects. It’s important to note that certain medical conditions or previous treatments may prevent you from participating, so be sure to discuss your health history with the trial team.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • At least 18 years of age.
- • Histologically confirmed unresectable or metastatic melanoma.
- • Subject has no prior systemic treatment for advanced disease.
- • Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- • Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
- • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Key Exclusion Criteria:
- • Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
- • Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
- • Subject has active central nervous system (CNS) metastases not previously treated.
- • Ocular melanoma.
- • Subject has active or known immune-mediated disorders.
- • Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
- • Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
- • Other protocol-defined inclusion/exclusion criteria apply.
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Barcelona, , Spain
Santa Fe, , Argentina
Reggio Emilia, , Italy
Tartu, , Estonia
Praha 2, , Czechia
Kuching, Sarawak, Malaysia
Pavia, , Italy
Napoli, , Italy
Barcelona, , Spain
Praha 2, , Czech Republic
Kuching, Sarawak, Malaysia
Tallinn, , Estonia
Kubang Kerian, Kelantan, Malaysia
Rozzano, Milano, Italy
Sibiu, , Romania
Johannesburg, Gauteng, South Africa
Hradec Kralove, , Czechia
Lisboa, , Portugal
Mostar, , Bosnia And Herzegovina
Osijek, Osjecko Baranjska županija, Croatia
Seoul, , Korea, Republic Of
Ploiesti, Prahova, Romania
Iasi, , Romania
Osijek, , Croatia
Firenze, , Italy
Tuzla, , Bosnia And Herzegovina
Beirut, , Lebanon
Rosario, Santa Fe, Argentina
Kraaifontein, Western Cape, South Africa
Sarajevo, , Bosnia And Herzegovina
Songkhla, , Thailand
Craiova, Dolj, Romania
Lisboa, , Portugal
Kragujevac, , Serbia
Istanbul, , Turkey
Bursa, , Turkey
Suwon Si, , Korea, Republic Of
Bergamo, , Italy
Porto, , Portugal
Málaga, , Spain
Rozzano, Milano, Italy
Badalona, Barcelona, Spain
Milano, , Italy
Tartu, Tartumaa, Estonia
Vilnius, , Lithuania
Lisboa, , Portugal
Cluj Napoca, , Romania
Seoul, , Korea, Republic Of
Ankara, , Turkey
Reggio Emilia, , Italy
Ankara, , Turkey
Ankara, , Turkey
Viña Del Mar, , Chile
Barcelona, , Spain
Santiago, , Chile
Madrid, , Spain
Baguio City, Benguet, Philippines
Hanoi, , Vietnam
Ankara, , Turkey
Napoli, , Italy
Zenica, , Bosnia And Herzegovina
Tbilisi, , Georgia
Ankara, , Turkey
Changhua, , Taiwan
San Juan City, National Capital Region, Philippines
Pretoria, Gauteng, South Africa
Málaga, , Spain
Parktown, Johannesburg, Gauteng, South Africa
Batumi, Ajaria, Georgia
Baltimore, Maryland, United States
Viedma, Río Negro, Argentina
Monterrey, Nuevo León, Mexico
Lisboa, , Portugal
Napoli, , Italy
Barcelona, , Spain
Sakarya, , Turkey
Rosario, , Argentina
Roma, , Italy
La Serena, , Chile
Ankara, , Turkey
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Köln, Nordrhein Westfalen, Germany
Poitiers, Haute Vienne, France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Busan, Busan Gwang'yeogsi [Pusan Kwan, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Pulau Pinang, Pahang, Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Breda, Noord Brabant, Netherlands
El Palmar, Murcia, Región De, Spain
Sevilla, , Spain
Springfield, Missouri, United States
Fredericton, New Brunswick, Canada
Bari, , Italy
Cape Town, Western Cape, South Africa
Sevilla, Andalucía, Spain
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Tbilisi, , Georgia
Fort Wayne, Indiana, United States
Zagreb, Grad Zagreb, Croatia
Frankfurt/Main, Hessen, Germany
Johannesburg, Gauteng, South Africa
Caceres, Cáceres, Spain
New Taipei City, Taipei, Taiwan
Taipei, , Taiwan
Milano, , Italy
Putrajaya, Selangor, Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Zagreb, Grad Zagreb, Croatia
La Serena, Coquimbo, Chile
Roma, , Italy
Taormina, Messina, Italy
Guadalajra, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Juchitan, Oaxaca, Mexico
Merida, Yucatán, Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Puebla, , Mexico
San Luis Potosí, , Mexico
San Pedro Garza Garcia, , Mexico
San Pedro Garza García, , Mexico
Tlalnepantla De Baz, , Mexico
Lisboa, , Portugal
Floresti, Cluj, Romania
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Madrid,, Madrid, Spain
Guadalajara, Jalisco, Mexico
Baton Rouge, Louisiana, United States
San Luis Potosi, San Luis Potosí, Mexico
Culiacan, Sinaloa, Mexico
Mexico City, , Mexico
Merida, Yucatán, Mexico
Long Beach, California, United States
Viedma, Río Negro, Argentina
Mar Del Plata, , Argentina
Khonkaen, Khon Kaen, Thailand
East Syracuse, New York, United States
Roma, , Italy
Siena, , Italy
Varese, , Italy
Leon, Guanajuato, Mexico
Cluj Napoca, Cluj, Romania
Sremska Kamenica, Vojvodina, Serbia
Caba, , Argentina
Köln, Nordrhein Westfalen, Germany
Taichung, Taichung Municipality, Taiwan
Lille, Nord, France
Lisboa, , Portugal
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Lisboa, , Portugal
Aguascalientes, , Mexico
Makati City, National Capital Region, Philippines
San Juan City, National Capital Region, Philippines
Setubal, Setúbal, Portugal
Gaziantep, , Turkey
Izmir, , Turkey
Batumi, Ajaria, Georgia
Suwon Si, Gyeonggido [Kyonggi Do], Korea, Republic Of
Cluj Napoca, Cluj, Romania
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Cebu City, , Philippines
Chisinau, , Moldova, Republic Of
Pasig City, Metropolitan Manila, Philippines
Ankara, , Turkey
Kocaeli, , Turkey
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Meldola, Forli, Italy
Chisinau, , Moldova, Republic Of
Ft. Wayne, Indiana, United States
Hradec Kralove, , Czech Republic
Mexico City, México, Mexico
Manila/Ermita, National Capital Region, Philippines
Bacolod City, Negros Occidental, Philippines
Pretoria, Gauteng, South Africa
Frankfurt/Main, Hessen, Germany
Lisboa, , Portugal
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Istanbul, , Turkey
Cagayan De Oro City, Misamis Oriental, Philippines
Yenimahalle/Ankara, Ankara, Turkey
Temuco, , Chile
Crema, Cremona, Italy
Milano, , Italy
Ciudad De Mexico, Distrito Federal, Mexico
Hanoi, Ha Noi, Thu Do, Vietnam
Chiangmai, Chiang Mai, Thailand
Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam
Szeged, , Hungary
Yenimahalle/Ankara, Ankara, Turkey
Malatya, , Turkey
Temuco, , Chile
Rennes, Ille Et Vilaine, France
Frankfurt/Main, Hessen, Germany
Roma, , Italy
Samsun, , Turkey
Hanoi, Ha Noi, Thu Do, Vietnam
Gaziantep, , Turkey
Tbilisi, , Georgia
Ploiesti, Prahova, Romania
Bucuresti, , Romania
Songkhla, , Thailand
Alessandria, , Italy
Istanbul, , Turkey
Saida, Loubnâne Ej Jnoûbi, Lebanon
Beirut, , Lebanon
Gaziantep, , Turkey
Istanbul, , Turkey
Kocaeli, , Turkey
Meldola, Forli, Italy
Amman, 'Ammān, Jordan
Amman, 'Ammān, Jordan
Irbid, , Jordan
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Pulau Pinang, Pahang, Malaysia
Guadalajara, , Mexico
Porto, , Portugal
Craiova, Dolj, Romania
Barcelona, , Spain
Kyiv, Kyïv, Ukraine
Fredericton, New Brunswick, Canada
Praha 2, , Czechia
Tbilisi, , Georgia
Szeged, , Hungary
Amman, 'Ammān, Jordan
Tripoli, Loubnâne Ech Chemâli, Lebanon
Beirut, , Lebanon
Beirut, , Lebanon
Ciudad De Mexico, Distrito Federal, Mexico
Juchitan, Oaxaca, Mexico
San Luis Potosi, San Luis Potosí, Mexico
Aguascalientes, , Mexico
Guadalajara, , Mexico
Puebla, , Mexico
Cebu City, , Philippines
Setubal, Setúbal, Portugal
Lisboa, , Portugal
Kragujevac, , Serbia
Taipei, , Taiwan
Adana, , Turkey
Samsun, , Turkey
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Mostar, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Zenica, , Bosnia And Herzegovina
Hradec Kralove, , Czechia
Busan, Busan Gwang'yeogsi [Pusan Kwan, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Saida, Loubnâne Ej Jnoûbi, Lebanon
Beirut, , Lebanon
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Guadalajara, Jalisco, Mexico
Culiacan, Sinaloa, Mexico
Mexico City, , Mexico
San Pedro Garza Garcia, , Mexico
San Pedro Garza García, , Mexico
Tlalnepantla De Baz, , Mexico
Chisinau, , Moldova, Republic Of
Pasig City, Metropolitan Manila, Philippines
Makati City, National Capital Region, Philippines
Bacolod City, Negros Occidental, Philippines
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Sremska Kamenica, Vojvodina, Serbia
Sevilla, Andalucía, Spain
Changhua, , Taiwan
Chiangmai, Chiang Mai, Thailand
Khonkaen, Khon Kaen, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Yenimahalle/Ankara, Ankara, Turkey
Ankara, , Turkey
Gaziantep, , Turkey
Kocaeli, , Turkey
Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam
Sarajevo, Kanton Sarajevo, Bosnia And Herzegovina
Valparaiso, Valparaíso, Chile
Temuco, , Chile
Roma, , Italy
Amman, , Jordan
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Leon, Guanajuato, Guanajuato, Mexico
Kragujevac, šumadijski Okrug, Serbia
Songkla, Songkhla, Thailand
Istanbul, , Turkey
Kocaeli, , Turkey
Fort Wayne, Indiana, United States
Baton Rouge, Louisiana, United States
Mar Del Plata, Río Negro, Argentina
Tuzla, , Bosnia And Herzegovina
Zagreb, Grad Zagreb, Croatia
Crema, Cremona, Italy
Taormina, Messina, Italy
Bergamo, , Italy
Napoli, , Italy
Roma, , Italy
Roma, , Italy
Varese, , Italy
Vilnius, , Lithuania
Cagayan De Oro City, Misamis Oriental, Philippines
Cluj Napoca, Cluj, Romania
Pretoria, Gauteng, South Africa
Kraaifontein, Western Cape, South Africa
Badalona, Barcelona, Spain
Caceres, Cáceres, Spain
Barcelona, , Spain
Málaga, , Spain
Valencia, , Spain
Ankara, , Turkey
Samsun, , Turkey
Moncton, New Brunswick, Canada
Estacion Central, Santiago, Chile
Achrafieh, Beirut, Lebanon
Monterrey, Nuevo León, Mexico
Iloilo City, Iloilo, Philippines
Bellville, Western Cape, South Africa
Yenimahalle/Ankara, Ankara, Turkey
Istanbul, , Turkey
Sremska Kamenica, Vojvodina, Serbia
Kragujevac, šumadijski Okrug, Serbia
Sevilla, , Spain
Bucuresti, , Romania
Pretoria, Gauteng, South Africa
Meldola, Forli, Italy
Bari, , Italy
Cape Town, Western Cape, South Africa
Konya, , Turkey
Bangkok, , Thailand
Bangkok, , Thailand
Viedma, , Argentina
Kragujevac, , Serbia
El Palmar, , Spain
Baton Rouge, Louisiana, United States
Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Valparaiso, , Chile
Poitier, Haute Vienne, France
Amman, , Jordan
Amman, , Jordan
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Tripoli, , Lebanon
Saida, , Lebanon
Monterrey, , Mexico
Monterrey, , Mexico
San Luis Potosi, , Mexico
Merida, , Mexico
Setubal, , Portugal
Caceres, , Spain
Bangkok, , Thailand
Sakarya, , Turkey
Kyiv, , Ukraine
Hanoi, , Vietnam
Ho Chi Minh, , Vietnam
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported