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NCT04674683

PHASE3

Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma

Sponsor: HUYABIO International, LLC.

View on ClinicalTrials.gov

Summary

This is a clinical study to compare the efficacy and safety of HBI-8000 combined with nivolumab to Placebo combined with nivolumab in patients with unresectable or metastatic melanoma. A separate open-label cohort of adults with new, progressive brain metastasis or adolescents with or without new progressive brain metastasis receive HBI-8000 combined with nivolumab.

Official title: A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2021-08-12

Completion Date

2026-12

Last Updated

2025-09-24

Healthy Volunteers

Conditions

Unresectable or Metastatic Melanoma Progressive Brain Metastasis

Interventions

DRUG

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.

DRUG

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.

Inclusion Criteria: 1. Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition). 2. Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization. 3. Tumor tissue available for PD-L1 testing at central lab or local laboratory; results must be obtained prior to randomization. In the event when archived tumor tissue is not available, new tumor biopsy or historical PD-L1 test results may be used for randomization, however tumor tissue, either taken previously or newly acquired, must be provided for central biomarker confirmation for final data analyses. PD-L1 expression level is required for randomization. In order to be randomized, a patient must be classified as PD-L1 positive or PD-L1 negative according to the following criteria: * PD-L1 positive (≥ 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) vs * PD-L1 negative (\< 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells). Note: If an insufficient amount of tumor tissue is available prior to the start of the screening phase, patients must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses. 4. Males or females 12 years of age or older. 5. ECOG performance status ≤1 for age ≥18 years, Lansky performance status ≥80% for age 12 to 17 years. 6. At least one measurable lesion defined by RECIST 1.1 criteria, (separate from the lesion to be used for tumor tissue collection) not counting brain metastasis with: * Longest diameter ≥10 mm by CT (when slice thickness is ≤5 mm); or ≥ 2× slice thickness (when slice thickness is \>5 mm) * Pathologically enlarged lymph node: ≥15 mm in short axis by CT (when slice thickness is ≤5 mm) * Clinical: ≥10 mm (that can be accurately measured with calipers). 7. Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or metastatic melanoma, except for the following, provided that the patient has recovered from all treatment-related toxicities: * BRAF mutation targeting therapy \> 4 weeks before administration of Study Treatment. * Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors or anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4) is allowed if disease progression/or recurrence had occurred at least 6 months after the last dose of neoadjuvant/adjuvant therapy and prior to receiving the first dose on this study and no clinically significant immune related toxicities leading to treatment discontinuation were observed * Adjuvant interferon therapy must have been completed \> 6 weeks before administration of Study Treatment 8. Any prior radiotherapy or minor surgery must be completed at least 2 weeks and 1 week respectively before Day 1 dosing and recovered from all treatment related toxicities 9. Screening laboratory results within 14 days prior to randomization: * Hematology: WBC ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100 × 103/μL, hemoglobin ≥10.0 g/dL independent of transfusion. The use of erythropoietic growth factor to achieve hemoglobin (Hgb) ≥ 10 g/dl is acceptable. * The CrCL≥ 30 mL/min using Cockcroft-Gault formula. * AST and ALT ≤3 × ULN, alkaline phosphatase ≤2.5 × ULN unless bone metastases present (patients with documented bone metastases: alkaline phosphatase \<5 x ULN), bilirubin ≤ 1.5 × ULN (unless known Gilbert's disease where it must be ≤ 3 × ULN), serum albumin ≥ 3.0 g/dL). 10. Negative serum pregnancy test at baseline for women of childbearing potential. 11. Females of childbearing potential (non-surgically sterile or premenopausal female capable of becoming pregnant) and all males (due to potential risk of drug exposure through the ejaculate) must agree to use adequate birth control measures from study start, during the study and for 5 months after the last dose of Study Drug. Acceptable methods of birth control in this trial include two highly effective methods of birth control (as determined by the Investigator; one of the methods must be a barrier technique) or abstinence. 12. Have the ability to understand and the willingness to sign a written informed consent document, comply with study scheduled treatment, visits and assessments. Exclusion Criteria: 1. History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies. 2. Previous treatment with a PD-1, PD-L1, PD-L2, CTLA-4 inhibitor, or any other agents targeting T-cell co-stimulation or immune checkpoint pathways for unresectable or metastatic melanoma. 3. Recipient of solid organ transplant. 4. History of a cardiovascular illness including: congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months prior to first dose of Study Treatment; or symptomatic cardiac arrhythmia despite medical management. QT interval corrected by heart rate using QTcF \>450 ms in males or \>470 ms in females, or congenital long QT syndrome. 5. Uncontrolled hypertension, systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg. 6. Patients with new, active, or progressive brain metastases or leptomeningeal disease with except when considered for a separate special open-label cohort. 7. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer, or bowel resection that affects absorption of orally administered drugs. 8. Active, known, or suspected autoimmune disease, except for Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy. 9. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. 10. Known history of testing positive for HIV, known AIDS. 11. Hepatitis B surface antigen positive or hepatitis C antibody positive. Further investigation per institutional practices may be performed to exclude active infection. 12. Patients with a condition requiring chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days before administration of Study Treatment. Inhaled or topical steroids, or adrenal replacement dose of corticosteroids at dose ≤ 10 mg/day prednisone equivalent are permitted. 13. Use of another investigational agent (drug or vaccine not marketed for any indication) within 28 days or before administration of Study Treatment. If the investigational agent is a monoclonal antibody then within 3 months before administration of Study Treatment 14. Pregnant or breast-feeding women. 15. Have a history of any other malignancy unless in remission for 2 years or locally curable cancers that have been treated with curative intent with no evidence of recurrence, such as: * Basal or squamous cell skin cancer * Superficial bladder cancer * Carcinoma in situ of cervix or breast * Incidental prostate cancer * Non melanomatous skin cancer * Prostate cancer treated with curative intent with serum prostate specific antigen (PSA) \< 2.0 ng/mL 16. Patients with medical conditions requiring administration of strong cytochrome P450 (CYP), CYP3A4 Inducers and Inhibitors with no alternative therapy. 17. Uncontrolled adrenal insufficiency or active chronic liver disease. 18. Has received approved live vaccine/live attenuated vaccines within 30 days of planned Cycle 1 Day 1. Inactivated viral vaccines or vaccines based upon subviral component are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are not allowed. COVID-19 vaccination should be administered at least 7 days before Cycle 1 Day 1. 19. Underlying medical conditions that, in the Investigator's opinion, will make the administration of Study Treatment hazardous or obscure the interpretation of toxicity determination or AEs. 20. Patients with a history of or active interstitial lung disease (ILD) or non-infectious pneumonitis. 21. Patients with prior organ or hematopoietic cell transplant (HCT), including allogeneic HCT. 22. Patients with known sensitivity to any of the ingredients of the Study Treatment. 23. Patients who received radiation therapy within 14 days of the first dose of the Study Treatment. 24. Patients who take drugs that prolong the QT interval or cause torsades de pointes or produce significant ventricular dysrhythmias. 25. Patients that are unwilling or unable to comply with procedures required in this protocol.

Locations (139)

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Innovative Clinical Research Institute (ICRI)

Pasadena, California, United States

Emad Ibrahim, MD, INC

Redlands, California, United States

Kaiser Permanente Oncology Research

Riverside, California, United States

California Cancer Associates for Research and Excellence, Inc. (cCARE)

San Marcos, California, United States

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Orlando Health

Orlando, Florida, United States

Ascension Sacred Heart Medical Oncology

Pensacola, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Goshen Center for Cancer Care

Goshen, Indiana, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Frederick Memorial Healthcare System

Frederick, Maryland, United States

St Louis Cancer Care

Bridgeton, Missouri, United States

AMR Kansas City

Kansas City, Missouri, United States

Medisearch Clinical Trials

Saint Joseph, Missouri, United States

St. Vincent - Frontier Cancer Center

Billings, Montana, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Thomas Jefferson University Medical Oncology Clinic

Philadelphia, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

Carolina Blood and Cancer Care Associates

Lancaster, South Carolina, United States

Renovatio Clinical

The Woodlands, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Froedtert Hospital, Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

University of the Sunshine Coast

Buderim, Queensland, Australia

Icon Cancer Centre Wesley

South Brisbane, Queensland, Australia

Ballarat Health Services

Ballarat, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

Royal Brisband and Women's Hospital

Brisbane, Australia

Liverpool Hospital

Liverpool, Australia

Affinity Clinical Research

Nedlands, Australia

Tweed Hospital

Tweed Heads, Australia

Calvary Mater Newcastle

Waratah, Australia

Medical University of Graz Department of Dermatology and Venerology

Graz, Austria

Univ.-Lkinik für Dermatologie, Venerologie und Allergologie

Innsbruck, Austria

AZ Klina

Brasschaat, Belgium

Cliniques Universitaires

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Hospital de la Citadelle

Liège, Belgium

Clinique Saint-Pierre

Ottignies, Belgium

Ensino e Terapia de Inovação Clίnica AMO-ETICA

Salvador, Estado de Bahia, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer,

Curitiba, Paraná, Brazil

Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

Hospital São Vicente de Paulo

Centro, Rio Grande do Sul, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Centro Gaúcho Integrado de Oncologia, Hematologia

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clίnίcas de Porto Alegre

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Oncosite-Centro de Pesquisa Clίnica em Oncologia

São Cristóvão, Rio Grande do Sul, Brazil

Hopital de Câncer de Barretos-Fundação Pio XII

Barretos, São Paulo, Brazil

Fundação Doutor Amaral Carvalho

Jaú, São Paulo, Brazil

CEPHO-Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto do Cancer do Estado de São Paulo - "Octavio Frias de Oliveira"-ICESP

São Paulo, São Paulo, Brazil

Fakultni nemocnice Olomoue

Olomouc, Czechia

Fakultni nemocnice Ostrava Kozni oddeleni

Ostrava-Poruba, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

CHU de Besançon - Hôpital Jean MINJOZ

Besançon, France

Hôpital Ambroise Paré

Boulogne-Billancourt, France

CHU de Dijon, Service de dermatologie

Dijon, France

CHU Grenoble Alpes

La Tronche, France

CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie

Lille, France

Hôpital La Timone

Marseille, France

Hôpital Saint-Louis

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU de Rouen-Hôpital

Rouen, France

Institut Gustave Roussy, Service de Dermatologie

Villejuif, France

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, Germany

Vivantes Klinikum Spandau, Dermatologie und Allergologie

Berlin, Germany

Universitaetsklinikum Koeln, Dermatologie und Venerologie,

Cologne, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

Dresden, Germany

Helios Klinikum Erfurt, Dermatologie und Allergologie

Erfurt, Germany

Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz

Essen, Germany

Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie

Freiburg im Breisgau, Germany

Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie

Heidelberg, Germany

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Leipzig, Germany

Universitaetsklinikum Schleswig Holstein - Campus Luebeck

Lübeck, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik

Mainz, Germany

Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,

Mannheim, Germany

Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen

Tübingen, Germany

Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica

Milan, Milano, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, Italy

A.O.S. Maria della Misericordia, Oncologia Medica

Perugia, Perugia, Italy

IRCCS Giovanni Paolo II Oncologia Medica

Bari, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica

Misterbianco, Italy

Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa

Naples, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - U.O. Oncologia Medica

Palermo, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica

Siena, Italy

Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona

Verona, Italy

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

National Hospital Organization Osaka National Hospital

Chuo Ku, Osaka, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Sunto-gun, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Tokho, Japan

Auckland City Hospital

Auckland, New Zealand

Waikato Hospital

Hamilton, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Hospial Oncologico, Puerto Rico Medical Center

Rio Piedras, Puerto Rico, Puerto Rico

National Cancer Centre

Singapore, Singapore

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Wilgers Oncology Centre

Pretoria, Gauteng, South Africa

Curo Oncology

Pretoria, Gauteng, South Africa

West Rand Oncology Centre Flora Clinic

Roodepoort, Gauteng, South Africa

Excellentis Clinical Trial Consultants

George, Western Cape, South Africa

Cape Town Oncology Trials Cape Gate Oncology Centre

Kraaifontein, Western Cape, South Africa

Cancercare Rondebosch Oncology

Rondebosch, Western Cape, South Africa

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Cha University Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Severance Hospital Younsei University Health System,

Seoul, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Catalan Institute of Oncology

Barcelona, Spain

ICO Badalona-Hospital Universitari Germans Trias I Pujol

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario Fundación Jimenez Diaz

Madrid, Spain

Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Universitario Clinico San Carlos

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Nuffield Health Wessex Hospital

Eastleigh, Hampshire, United Kingdom

Edinburgh Cancer Center Western General Hospital

Edinburgh, United Kingdom

Clinical Research Directory

Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (139)