450
Participants
Start Date
August 12, 2021
Primary Completion Date
July 31, 2026
Study Completion Date
December 31, 2026
HBI-8000 in combination with nivolumab
Patients will take 30 mg of HBI-8000 orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV will be administered by intravenous infusion at specific doses on specific days in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice. In adolescent patients with body weight \< 40 kg, nivolumab will be dosed at specific doses on specific days.
Placebo in combination with nivolumab
Patients will take 30 mg of Placebo orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV at specific doses will be administered by intravenous infusion in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice.
Cliniques Universitaires, Brussels
Clinique Saint-Pierre, Ottignies
West Rand Oncology Centre Flora Clinic, Roodepoort
The Medical Oncology Centre of Rosebank, Johannesburg
AZ Klina, Brasschaat
Tauranga Hospital, Tauranga
Jessa Ziekenhuis, Hasselt
Hospital de la Citadelle, Liège
University of the Sunshine Coast, Buderim
Univ.-Lkinik für Dermatologie, Venerologie und Allergologie, Innsbruck
Excellentis Clinical Trial Consultants, George
Cape Town Oncology Trials Cape Gate Oncology Centre, Kraaifontein
Cancercare Rondebosch Oncology, Rondebosch
Medical University of Graz Department of Dermatology and Venerology, Graz
AZ Maria Middelares, Ghent
Fakultni nemocnice Kralovske Vinohrady, Prague
Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin
National Cancer Center, Goyang-si
Cha University Bundang Medical Center, Seongnam-si
Vivantes Klinikum Spandau, Dermatologie und Allergologie, Berlin
Thomas Jefferson University Medical Oncology Clinic, Philadelphia
Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Frederick Memorial Healthcare System, Frederick
Inova Schar Cancer Institute, Fairfax
Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Lübeck
Southeastern Medical Oncology Center, Goldsboro
MD Anderson Cancer Center, Madrid
Hospital Universitario Fundación Jimenez Diaz, Madrid
Centro Integral Oncologico Clara Campal, Madrid
Levine Cancer Institute, Charlotte
Hospital Regional Universitario de Málaga, Málaga
AnMed Health, Anderson
Carolina Blood and Cancer Care Associates, Lancaster
Baptist MD Anderson Cancer Center, Jacksonville
Ascension Sacred Heart Medical Oncology, Pensacola
Orlando Health, Orlando
Memorial Regional Hospital, Hollywood
Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton
Moffitt Cancer Center, Tampa
Chungnam National University Hospital, Daejeon
Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona, Verona
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS, Bologna
Baptist Health Lexington, Lexington
St. Elizabeth Healthcare, Edgewood
Toledo Clinic Cancer Center, Toledo
Gabrail Cancer Center Research, Canton
Goshen Center for Cancer Care, Goshen
Universitaetsklinikum Koeln, Dermatologie und Venerologie,, Cologne
A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica, Siena
Froedtert Hospital, Medical College of Wisconsin, Milwaukee
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik, Mainz
Chonnam National University Hwasun Hospital, Hwasun
St. Vincent - Frontier Cancer Center, Billings
St Louis Cancer Care, Bridgeton
AMR Kansas City, Kansas City
Medisearch Clinical Trials, Saint Joseph
Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,, Mannheim
Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie, Heidelberg
IRCCS Giovanni Paolo II Oncologia Medica, Bari
Fakultni nemocnice Ostrava Kozni oddeleni, Ostrava-Poruba
Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen, Tübingen
CHU de Rouen-Hôpital, Rouen
Renovatio Clinical, The Woodlands
Fakultni nemocnice Olomoue, Olomouc
Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie, Freiburg im Breisgau
Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa, Napoli
Utah Cancer Specialists, Salt Lake City
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - U.O. Oncologia Medica, Palermo
Innovative Clinical Research Institute (ICRI), Pasadena
UC San Diego Moores Cancer Center, La Jolla
California Cancer Associates for Research and Excellence, Inc. (cCARE), San Marcos
Emad Ibrahim, MD, INC, Redlands
Kaiser Permanente Oncology Research, Riverside
Comprehensive Blood and Cancer Center, Bakersfield
Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica, Misterbianco
Helios Klinikum Erfurt, Dermatologie und Allergologie, Erfurt
National Cancer Centre, Singapore
Sydney Adventist Hospital, Wahroonga
Icon Cancer Centre Wesley, South Brisbane
Ballarat Health Services, Ballarat
Goulburn Valley Health, Shepparton
Royal Brisband and Women's Hospital, Brisbane
Liverpool Hospital, Liverpool
Affinity Clinical Research, Nedlands
Tweed Hospital, Tweed Heads
Calvary Mater Newcastle, Waratah
CHU de Besançon - Hôpital Jean MINJOZ, Besançon
Hôpital Ambroise Paré, Boulogne-Billancourt
CHU de Dijon, Service de dermatologie, Dijon
CHU Grenoble Alpes, La Tronche
CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie, Lille
Hôpital Saint-Louis, Paris
Centre Hospitalier Lyon Sud, Pierre-Bénite
Institut Gustave Roussy, Service de Dermatologie, Villejuif
Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz, Essen
Auckland City Hospital, Auckland
Waikato Hospital, Hamilton
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitario Clinico San Carlos, Madrid
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Miguel Servet, Zaragoza
Ensino e Terapia de Inovação Clίnica AMO-ETICA, Salvador
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer,, Curitiba
Hospital do Câncer de Londrina, Londrina
Hospital São Vicente de Paulo, Centro
Hospital Bruno Born, Lajeado
Centro Gaúcho Integrado de Oncologia, Hematologia, Porto Alegre
Hospital de Clίnίcas de Porto Alegre, Santa Cruz do Sul
Oncosite-Centro de Pesquisa Clίnica em Oncologia, São Cristóvão
Hopital de Câncer de Barretos-Fundação Pio XII, Barretos
Fundação Doutor Amaral Carvalho, Jaú
CEPHO-Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto
"Instituto do Cancer do Estado de São Paulo - Octavio Frias de Oliveira-ICESP", São Paulo
Hôpital La Timone, Marseille
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie, Dresden
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Leipzig
A.O.S. Maria della Misericordia, Oncologia Medica, Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma
National Hospital Organization Kyushu Cancer Center, Fukuoka
Shinshu University Hospital, Matsumoto
Niigata Cancer Center Hospital, Niigata
Okayama University Hospital, Okayama
National Hospital Organization Osaka National Hospital, Chuo Ku
Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka
Shizuoka Cancer Center, Nagaizumi-cho
The Cancer Institute Hospital of JFCR, Kōtoku
Hospial Oncologico, Puerto Rico Medical Center, Rio Piedras
Wilgers Oncology Centre, Pretoria
Curo Oncology, Pretoria
Severance Hospital Younsei University Health System,, Seoul
Severance Hospital Yonsei University Health System, Seoul
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clinic de Barcelona, Barcelona
Catalan Institute of Oncology, Barcelona
ICO Badalona-Hospital Universitari Germans Trias I Pujol, Barcelona
Nuffield Health Wessex Hospital, Eastleigh
Edinburgh Cancer Center Western General Hospital, Edinburgh
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
HUYABIO International, LLC.
INDUSTRY