A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

NCT06054555 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202100312023-503288-40
• Study Type: interventional
• Target: 633
• Locations: 30 countries
• Sites: 170

Brief Summary

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Conditions

Melanoma

Keywords

Treatment-naive; Unresectable melanoma; Metastatic melanoma

Outcome Measures

Primary Outcomes (5)

• Objective response by Week 49

  Week 49

• Objective response at Week 17

  Week 17

• Progression-free survival (PFS)

  From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)

• Overall survival (OS)

  From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

• Duration of response (DOR)

  From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

Secondary Outcomes (5)

• Number of subjects with treatment-emergent adverse events

  Week 1 until Week 105

• Number of subjects with treatment-emergent serious adverse events

  Week 1 until Week 105

• Number of subjects with treatment-emergent adverse events of interest

  Week 1 until Week 105

• Number of subjects with anti-drug antibodies

  Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

• Serum concentrations of ABP 206 and nivolumab (Ctrough)

  Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

Study Arms (2)

ABP 206

EXPERIMENTAL

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Drug: ABP 206

Nivolumab

ACTIVE COMPARATOR

Subjects will receive Dose A of Nivolumab via IV infusion.

Drug: Nivolumab

Interventions

ABP 206 DRUG

ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.

ABP 206

Nivolumab DRUG

Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Also known as: OPDIVO®

Nivolumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (180)

Cancer and Blood Specialty clinic

Long Beach, California, 90806, United States

Location

Fort Wayne Medical Oncology and Hematology - Office of Clinical Research

Fort Wayne, Indiana, 46825, United States

Location

Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion

Baton Rouge, Louisiana, 70809, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807-5287, United States

Location

Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP

East Syracuse, New York, 13057, United States

Location

Centro de Investigaciones Médicas y Desarrollo LC

Buenos Aires, Ciudad Autónoma de Buenos Aire, 1125, Argentina

Location

Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology

Mar Del Plata, Río Negro Province, 7600, Argentina

Location

Clínica Viedma - Oncology

Viedma, Río Negro Province, R8500JYJ, Argentina

Location

Instituto De Oncologia De Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

ISIS Clinica Especializada

Santa Fe, S3000FFU, Argentina

Location

Clinical Center University of Sarajevo - Clinic of Oncology

Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Center of Republic of Srpska

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla - Oncology, Hematology and Radio

Tuzla, Tuzlanski Kanton, 75000, Bosnia and Herzegovina

Location

Cantonal hospital Zenica - Oncology

Zenica, Zeničko-dobojski Kanton, 72000, Bosnia and Herzegovina

Location

Dr. Everett Chalmers Hospital - Oncology

Fredericton, New Brunswick, E3B 5N5, Canada

Location

IC La Serena Research

La Serena, Coquimbo Region, 1720430, Chile

Location

Centro de Investigacion y Desarrollo Oncologico

Temuco, Región de la Araucanía, 4810218, Chile

Location

Oncocentro Apys

Valparaíso, Región de Valparaíso, 2363058, Chile

Location

Icegclinic Research & Care

Estacion Central, Santiago Metropolitan, 8241479, Chile

Location

University Hospital Centre Zagreb - Oncology department

Zagreb, City of Zagreb, 10 000, Croatia

Location

Poliklinika Anova

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Osijek

Osijek, Osjecko-baranjska Županija, 31000, Croatia

Location

FN Hradec Kralove - Klinika onkologie a radioterap

Hradec Kralove, Moravskoslezský kraj, 500 05, Czechia

Location

Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka

Prague, 128 08, Czechia

Location

Tartu University Hospital - Oncology

Tartu, Tartu, 51014, Estonia

Location

CHU de Poitiers

Poitier, Haute-Vienne, 21079, France

Location

Centre Hospitalier De Saint Malo - Oncologie

Rennes, Ille-et-Vilaine, 35042, France

Location

C.H.R.U Hopital Claude Huriez - Dermatologie

Lille, Nord, 59037, France

Location

LTD "High technology hospital MEDCENTER"

Batumi, Adjara, 6010, Georgia

Location

LLC "Todua Clinic"

Tbilisi, 0112, Georgia

Location

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, 0112, Georgia

Location

JSC "K.Eristavi National Center of Experimental and Clinical Surgery"

Tbilisi, 0159, Georgia

Location

LTD "Multprofile Clinic Consilium Medulla" - Oncology

Tbilisi, 0186, Georgia

Location

Goethe University Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Philipps-University Marburg

Marburg, Hesse, 35043, Germany

Location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico

Crema, Cremona, 26013, Italy

Location

IRST Dino Amadori (IRST IRCCS) - UNK

Meldola, Forli, 47014, Italy

Location

PO Ospedale San Vincenzo - Oncologia Medica

Taormina, Messina, 98039, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

AO Ss Antonio, Biagio e Arrigo

Alessandria, 15121, Italy

Location

AUO Consorziale-Policlinico Bari

Bari, 70124, Italy

Location

Istituto dei Tumori Giovanni Paolo II - Oncologia Medica - Tumori Rari e Melanoma

Bari, 70124, Italy

Location

ASST Papa Giovanni XXIII - Oncologia

Bergamo, 24127, Italy

Location

AOU Careggi

Florence, 50134, Italy

Location

IRCCS Ca'Granda Maggiore Policlinic

Milan, 20122, Italy

Location

Ospedale San Raffaele, IRCCS - Oncologia Medica

Milan, 20132, Italy

Location

AOU Luigi Vanvitelli

Naples, 80131, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Location

Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare

Naples, 80147, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica

Roma, 00128, Italy

Location

IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)

Roma, 00144, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia

Roma, 00167, Italy

Location

Ospedale Isola Tiberina - Gemelli Isola - Oncologia Medica

Roma, 00186, Italy

Location

AOU Senese, Policlinico Le Scotte

Siena, 53100, Italy

Location

Ospedale di Circolo, Presidio di Varese - Oncologia

Varese, 21100, Italy

Location

Al Khalidi Hospital and Medical Center - Research

Amman, 'Ammān, Jordan

Location

The Speciality Hospital (TSH) / Advanced Clinical Center

Amman, 'Ammān, Jordan

Location

King Hussein Cancer Center

Amman, 11941.0, Jordan

Location

Pharmaceutical Research Center (KAUH)

Irbid, Jordan

Location

Saint George Hospital University Medical Center

El Achrafiyé, Beyrouth, 00000, Lebanon

Location

Nini Hospital

Tripoli, Loubnâne Ech Chemâli, 00000, Lebanon

Location

Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology

Saida, Loubnâne Ej Jnoûbi, 652, Lebanon

Location

Ain Wazein Hospital - internal medicine

Beirut, +961, Lebanon

Location

American University of Beirut Medical Center - Haematology

Beirut, 00000, Lebanon

Location

Hotel Dieu de France Hospital - Oncology

Beirut, 111, Lebanon

Location

National Cancer Institute - Conservative Tumour Therapy

Vilnius, Vilnius County, LT-08660, Lithuania

Location

Hospital Pulau Pinang

Pulau Pinang, Pahang, 00000, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

National Cancer Institute - Radiotherapy and Oncology

Putrajaya, Selangor, 62250, Malaysia

Location

HOSPITAL UNIVERSITI SAINS MALAYSIA - Pediatrics

Kubang Kerian, Terengganu, 16150, Malaysia

Location

Hospital Kuala Lumpur - Surgery

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 00000, Malaysia

Location

Hospital Canselor Tuanku Muhriz UKM

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000, Malaysia

Location

Pantai Hospital Kuala Lumpur - Oncology

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 59100, Malaysia

Location

Preparaciones Oncologica SC

León, Guanajuato, 37000, Mexico

Location

Centro de Inm Onc de Occ Sa de Cv

Guadalajra, Jalisco, 44630, Mexico

Location

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico City, 3100, Mexico

Location

iCan Oncology Center Centro Medico AVE

Monterrey, Nuevo León, 64710, Mexico

Location

Centro Medico Zambrano Hellion TecSalud

Monterrey, Nuevo León, 66278, Mexico

Location

Althian - Research Management Center

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Centro de Estudios y Prevención del Cancer AC

Juchitán de Zaragoza, Oaxaca, 70000, Mexico

Location

Hospital Angeles Centro Médico San Luis Potosí - Cardiologia

San Luis Potosí City, San Luis Potosí, 78200, Mexico

Location

Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.

Culiacán, Sinaloa, 80020, Mexico

Location

Centro de Atención e Investigación Clínica en Oncología

Mérida, Yucatán, 97130, Mexico

Location

Centro de Investigación Médica Aguascalientes (CIMA) - Oncology

Aguascalientes, 68000, Mexico

Location

Boca Clinical Trials México

Guadalajara, 00000, Mexico

Location

Oncare Cancer Center Viaducto CdMx

Mexico City, 14080, Mexico

Location

ONCOCENTER PUEBLA - Dermatology

Puebla City, 72530, Mexico

Location

Clinical Research Institute

Tlalnepantla, 54055, Mexico

Location

Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology

Chisinau, Moldova, Republic of, MD-2025, Moldova

Location

Amphia Ziekenhuis - Molengracht

Breda, North Brabant, 4818 CK, Netherlands

Location

Baguio General Hospital and Medical Center - Oncology

Baguio City, Benguet, 2600, Philippines

Location

Cebu Doctors' University Hospital - Oncology

Cebu City, Cebu, 1000, Philippines

Location

The Medical City - Clinical Research Unit

Iloilo City, Iloilo, 00000, Philippines

Location

The Medical City - Neurology

Pasig, Metropolitan Manila, 1605, Philippines

Location

Cagayan de Oro Medical Center - Internal Medicine

Cagayan de Oro, Misamis Oriental, 9000, Philippines

Location

Center for Skin Research, Testing and Product Development

Makati City, National Capital Region, 1229, Philippines

Location

Philippine General Hospital

Manila/Ermita, National Capital Region, 1000, Philippines

Location

Cardinal Santos Madical Center

San Juan City, National Capital Region, 1502, Philippines

Location

Riverside Medical Center

Bacolod, Negros Occidental, 6100, Philippines

Location

Centro Hospitalar de Setúbal - Oncologia

Setúbal, Setúbal District, 2910446, Portugal

Location

Champalimaud Cancer Center

Lisbon, 1400-038, Portugal

Location

Unidade Local De Saude De Lisboa Ocidental E.P.E.

Lisbon, 1449-005, Portugal

Location

Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

Lisbon, 1649-035, Portugal

Location

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica

Lisbon, Portugal

Location

Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica

Porto, 4200-072, Portugal

Location

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Medical Oncology

Cluj-Napoca, Cluj, 400015, Romania

Location

Medisprof - Medical Oncology

Cluj-Napoca, Cluj, 400641, Romania

Location

Radiotherapy Center Cluj - Medical Oncology

Floreşti, Cluj, 407280, Romania

Location

Oncolab - Medical Oncology

Craiova, Dolj, 200385, Romania

Location

Centrul de Oncologie Sf Nectarie - Medical Oncology

Craiova, Dolj, 200746, Romania

Location

Medical Center Gral

Ploieşti, Prahova, 100010, Romania

Location

Spitalul Municipal Ploiesti - Oncologie

Ploieşti, Prahova, 100337, Romania

Location

Oncocenter- Oncologie Clinica - Medical Oncology

Timișoara, Timiș County, 300166, Romania

Location

Memorial Healthcare International - Oncology

Bucharest, 013823, Romania

Location

Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Medical Oncology I

Bucharest, 022328, Romania

Location

Centrul de Oncologie Euroclinic - Oncology

Iași, 700106, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu - Oncologie

Sibiu, 550245, Romania

Location

Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B

Kamenitz, Vojvodina, 21204, Serbia

Location

University Clinical Center of Kragujevac, Center for Internal Oncology

Kragujevac, Šumadijski Okrug, 34000, Serbia

Location

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, 2196, South Africa

Location

Wits Clinical Research

Parktown, Johannesburg, Gauteng, 2193, South Africa

Location

Steve Biko Academic Hospital

Pretoria, Gauteng, 0002, South Africa

Location

Curo Oncology

Pretoria, Gauteng, 0084, South Africa

Location

Little Company Of Mary Hospital - Oncology

Pretoria, Gauteng, 0181, South Africa

Location

Rainbow Oncology Centre

Durban, KwaZulu-Natal, 4058, South Africa

Location

Cape Gate Oncology Centre

Cape Town, Western Cape, 7570, South Africa

Location

Cancercare - Rondebosch Oncology

Cape Town, Western Cape, 7700, South Africa

Location

Inje University Haeundae Paik Hospital - Oncology

Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48108, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido [Kyonggi-do], 16247, South Korea

Location

Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722, South Korea

Location

Asan Medical Center - Oncology

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 05505, South Korea

Location

Samsung Medical Center - Family Medicine

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351, South Korea

Location

Hospital Universitario Virgen de la Macarena - Oncología Médica

Seville, Andalusia, 41009, Spain

Location

Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica

Badalona, Barcelona, 08916, Spain

Location

Hospital San Pedro de Alcántara - Oncología

Cáceres, Cáceres, 10003, Spain

Location

H.U.V.Arrixaca - Oncología

El Palmar, Murcia, Región de, 30120, Spain

Location

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau - Oncología Médica

Barcelona, 08041, Spain

Location

M.D. Anderson Center Madrid

Madrid, 28033, Spain

Location

Hospital Regional Universitario de Malaga - Servicio de Oncología

Málaga, 29011, Spain

Location

Hospital HLA Jerez Puerta Sur

Seville, 41009, Spain

Location

Consorcio Hospital General Universitario de Valencia - Oncología

Valencia, 46014, Spain

Location

China Medical University Hospital - Internal Medicine

Taichung, Taichung Municipality, 40447, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare

New Taipei City, Taipei, 23561, Taiwan

Location

Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine

Changhua, 50006, Taiwan

Location

Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology

Taipei, 11696, Taiwan

Location

Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)

Khonkaen, Changwat Khon Kaen, 40002, Thailand

Location

Prince of Songkla University

Songkhla, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiangmai Hospital - Medical Oncology

Muang, Chiang Mai, 50200, Thailand

Location

King Chulalongkorn Memorial Hospital [Medical Oncology]

Bangkok, Krung Thep Maha Nakhon [Bangko, 10330, Thailand

Location

Siriraj Hospital - Medical Oncology

Bangkok, Krung Thep Maha Nakhon [Bangko, 10700, Thailand

Location

Ramathibodi Hospital - Immunology and Rheumatology

Rajthevi, Krung Thep Maha Nakhon [Bangko, 10400, Thailand

Location

Gazi University Medical Faculty - Gynecology

Yenimahalle/Ankara, Ankara, 6500, Turkey (Türkiye)

Location

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

Kadıköy, Istanbul, 34722, Turkey (Türkiye)

Location

Adana City Training and Research Hospital

Adana, 01370, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital - Medical Oncology

Ankara, 06010, Turkey (Türkiye)

Location

Ankara University Medical Faculty - Medical Oncology

Ankara, 06590, Turkey (Türkiye)

Location

Ankara Liv Hospital

Ankara, 06680, Turkey (Türkiye)

Location

Memorial Ankara Hospital - Oncology

Ankara, 6520, Turkey (Türkiye)

Location

Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

Ankara, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Medical Point Gaziantep Hospital - Medical Oncology

Gaziantep, 27010, Turkey (Türkiye)

Location

Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and

Gaziantep, 27310, Turkey (Türkiye)

Location

Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology

Istanbul, 34098, Turkey (Türkiye)

Location

Koc Universitesi Hastanesi; Tıbbi Onkoloji

Istanbul, 34510, Turkey (Türkiye)

Location

Memorial Bahçelievler Hospital

Istanbul, 44280, Turkey (Türkiye)

Location

Izmir Medical Point Hastanesi

Izmir, 35560, Turkey (Türkiye)

Location

Kocaeli University Research and Practice Hospital - Medical Oncology

Kocaeli, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty - Oncology

Konya, 42080, Turkey (Türkiye)

Location

Sakarya Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Location

VM Medical Park Samsun Hospital - Medical oncology

Samsun, 00000, Turkey (Türkiye)

Location

Namik Kemal Universitesi - Tip Fakultesi

Tekirdağ, 59100, Turkey (Türkiye)

Location

TOV "ARENSIIa EKSPLORATORI MEDISIN"

Kyiv, Kyïv, 1135, Ukraine

Location

Hanoi Oncology Hospital

Hanoi, Ha Noi, Thu Do, 100000, Vietnam

Location

Vietnam National Cancer Hopsital

Hanoi, Ha Noi, Thu Do, 10000, Vietnam

Location

HCM Oncology Hospital - Medical Oncology

Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff) and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 26, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): January 25, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues, and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

BO (4); ES (1); CL (4); LI (1); GE (5); PH (9); DE (3); CA (1); KR (5); US (5); UA (1); CR (3); CZ (2); SE (2); TU (20); JO (4); TW (4); IT (22); PT (6); RO (12); ZA (9); FR (3); LE (6); VN (3); AR (5); MO (1); NL (1); ME (15); TH (6); MY (7)