AzTrials
AzTrials

Unresectable or Metastatic MelanomaPhase 3NCT04674683

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

A Phase 3 study testing HBI-8000 in combination with nivolumab in people with Unresectable or Metastatic Melanoma and Progressive Brain Metastasis, run by HUYABIO International, LLC. at 139 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
HBI-8000 in combination with nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
139 sitesin 17 countries
Study dates
12 Aug 2021to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).
  • Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization.
  • 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).
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  • 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.
  • Males or females 12 years of age or older.
  • ECOG performance status ≤1 for age ≥18 years, Lansky performance status ≥80% for age 12 to 17 years.
  • 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).
  • 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
  • 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
  • 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).
  • Negative serum pregnancy test at baseline for women of childbearing potential.
  • 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.
  • Have the ability to understand and the willingness to sign a written informed consent document, comply with study scheduled treatment, visits and assessments.

Who cannot join

  • History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies.
  • 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.
  • Recipient of solid organ transplant.
  • 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.
  • Uncontrolled hypertension, systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
  • Patients with new, active, or progressive brain metastases or leptomeningeal disease with except when considered for a separate special open-label cohort.
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  • History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer, or bowel resection that affects absorption of orally administered drugs.
  • 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.
  • Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
  • Known history of testing positive for HIV, known AIDS.
  • Hepatitis B surface antigen positive or hepatitis C antibody positive. Further investigation per institutional practices may be performed to exclude active infection.
  • 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.
  • 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
  • Pregnant or breast-feeding women.
  • 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
  • Patients with medical conditions requiring administration of strong cytochrome P450 (CYP), CYP3A4 Inducers and Inhibitors with no alternative therapy.
  • Uncontrolled adrenal insufficiency or active chronic liver disease.
  • 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.
  • 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.
  • Patients with a history of or active interstitial lung disease (ILD) or non-infectious pneumonitis.
  • Patients with prior organ or hematopoietic cell transplant (HCT), including allogeneic HCT.
  • Patients with known sensitivity to any of the ingredients of the Study Treatment.
  • Patients who received radiation therapy within 14 days of the first dose of the Study Treatment.
  • Patients who take drugs that prolong the QT interval or cause torsades de pointes or produce significant ventricular dysrhythmias.
  • Patients that are unwilling or unable to comply with procedures required in this protocol.

Trial locations and contacts

139 sites in 17 countries.

139 sites in 17 countries

United States31 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • St. Vincent - Frontier Cancer Center

    Billings, Montana, 59102

  • Boca Raton Regional Hospital, Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • St Louis Cancer Care

    Bridgeton, Missouri, 63044

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Frederick Memorial Healthcare System

    Frederick, Maryland, 21701

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

  • Carolina Blood and Cancer Care Associates

    Lancaster, South Carolina, 29720

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Froedtert Hospital, Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Orlando Health

    Orlando, Florida, 32806

  • Innovative Clinical Research Institute (ICRI)

    Pasadena, California, 91105

  • Ascension Sacred Heart Medical Oncology

    Pensacola, Florida, 32504

  • Thomas Jefferson University Medical Oncology Clinic

    Philadelphia, Pennsylvania, 19107

  • Emad Ibrahim, MD, INC

    Redlands, California, 92373

  • Kaiser Permanente Oncology Research

    Riverside, California, 92505

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

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

    San Marcos, California, 92069

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

Other trials in United States

Brazil13 sites

  • Hopital de Câncer de Barretos-Fundação Pio XII

    Barretos, São Paulo, 14784-400

  • Hospital São Vicente de Paulo

    Centro, Rio Grande do Sul, 99010-080

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer,

    Curitiba, Paraná, 81520-060

  • Fundação Doutor Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-010

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520

  • Centro Gaúcho Integrado de Oncologia, Hematologia

    Porto Alegre, Rio Grande do Sul, 90850-170

  • Ensino e Terapia de Inovação Clίnica AMO-ETICA

    Salvador, Estado de Bahia, 41950-610

  • Hospital de Clίnίcas de Porto Alegre

    Santa Cruz do Sul, Rio Grande do Sul, 96810-110

  • CEPHO-Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

  • Oncosite-Centro de Pesquisa Clίnica em Oncologia

    São Cristóvão, Rio Grande do Sul, 98700-000

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

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

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Germany13 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Vivantes Klinikum Spandau, Dermatologie und Allergologie

    Berlin, 13585

  • Universitaetsklinikum Koeln, Dermatologie und Venerologie,

    Cologne, 50937

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

    Dresden, 01307

  • Helios Klinikum Erfurt, Dermatologie und Allergologie

    Erfurt, 99089

  • Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz

    Essen

  • Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie

    Freiburg im Breisgau, 79104

  • Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie

    Heidelberg, 69120

  • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

    Leipzig, 04103

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    Lübeck, 23538

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik

    Mainz, 55131

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

    Mannheim, 68167

  • Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Spain12 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Catalan Institute of Oncology

    Barcelona, 08908

  • ICO Badalona-Hospital Universitari Germans Trias I Pujol

    Barcelona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Fundación Jimenez Diaz

    Madrid, 28040

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Clinico San Carlos

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Italy11 sites

  • IRCCS Giovanni Paolo II Oncologia Medica

    Bari, 70124

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138

  • Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica

    Milan, Milano, 20122

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Milano, 20133

  • Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica

    Misterbianco, 95045

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

    Naples, 80131

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

    Palermo, 90127

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

    Perugia, Perugia, 06132

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

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

    Siena, 53100

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

    Verona, 37134

Other trials in Italy

Australia10 sites

  • Ballarat Health Services

    Ballarat, Victoria

  • Royal Brisband and Women's Hospital

    Brisbane

  • University of the Sunshine Coast

    Buderim, Queensland, 4556

  • Liverpool Hospital

    Liverpool

  • Affinity Clinical Research

    Nedlands

  • Goulburn Valley Health

    Shepparton, Victoria

  • Icon Cancer Centre Wesley

    South Brisbane, Queensland

  • Tweed Hospital

    Tweed Heads

  • Sydney Adventist Hospital

    Wahroonga, New South Wales

  • Calvary Mater Newcastle

    Waratah

Other trials in Australia

France10 sites

  • 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 La Timone

    Marseille, 13385 Cedex 05

  • Hôpital Saint-Louis

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • CHU de Rouen-Hôpital

    Rouen, 76031

  • Institut Gustave Roussy, Service de Dermatologie

    Villejuif

Other trials in France

Japan8 sites

  • National Hospital Organization Osaka National Hospital

    Chuo Ku, Osaka, 540-0006

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • The Cancer Institute Hospital of JFCR

    Kōtoku, Tokho, 135-8550

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Shizuoka Cancer Center

    Nagaizumi-cho, Sunto-gun, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

Other trials in Japan

South Africa7 sites

  • Excellentis Clinical Trial Consultants

    George, Western Cape, 6529

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials Cape Gate Oncology Centre

    Kraaifontein, Western Cape, 7570

  • Wilgers Oncology Centre

    Pretoria, Gauteng, 0081

  • Curo Oncology

    Pretoria, Gauteng, 0084

  • Cancercare Rondebosch Oncology

    Rondebosch, Western Cape, 7700

  • West Rand Oncology Centre Flora Clinic

    Roodepoort, Gauteng, 1709

Other trials in South Africa

Belgium6 sites

  • AZ Klina

    Brasschaat, 2930

  • Cliniques Universitaires

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Hospital de la Citadelle

    Liège, 4000

  • Clinique Saint-Pierre

    Ottignies, 1340

Other trials in Belgium

South Korea6 sites

  • Chungnam National University Hospital

    Daejeon, Jung-gu, 35015

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Cha University Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Severance Hospital Younsei University Health System,

    Seoul, Gyeonggi-do, 03722

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

Czechia3 sites

  • Fakultni nemocnice Olomoue

    Olomouc, 77900

  • Fakultni nemocnice Ostrava Kozni oddeleni

    Ostrava-Poruba, 70852

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

New Zealand3 sites

  • Auckland City Hospital

    Auckland

  • Waikato Hospital

    Hamilton

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

Austria2 sites

  • Medical University of Graz Department of Dermatology and Venerology

    Graz, 8036

  • Univ.-Lkinik für Dermatologie, Venerologie und Allergologie

    Innsbruck, 6020

Other trials in Austria

United Kingdom2 sites

  • Nuffield Health Wessex Hospital

    Eastleigh, Hampshire, SO53 2DW

  • Edinburgh Cancer Center Western General Hospital

    Edinburgh, EH4 2XU

Other trials in United Kingdom

Puerto Rico1 site

  • Hospial Oncologico, Puerto Rico Medical Center

    Rio Piedras, Puerto Rico, 00935

Other trials in Puerto Rico

Singapore1 site

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

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

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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab. Randomization of eligible patients will be stratified by PD-L1 expression (positive, ≥1% expression level versus negative, <1% expression level) and LDH (normal versus elevated) in the main study. Adults with new, progressive brain metastasis, or adolescents with or without new progressive brain metastasis will be enrolled in a separate, non-randomized, open-label cohort to receive the combination of HBI-8000 and nivolumab.

In the main study, eligible patients will be randomized within the appropriate stratum at a 1:1 ratio to the Test arm or the Control arm. Study treatment will be initiated within 3 days of randomization.

A treatment cycle consists of 28 days. Patients will be treated with one of the following:

Test arm: HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days

Control arm: Placebo oral BIW + nivolumab IV at specific doses on specific days

The Study Treatment (HBI-8000 or Placebo) is administered approximately 30 minutes after a full meal.

The Study Treatment (HBI-8000 or Placebo) will be administered twice a week on the following days of every 28-day cycle:

  • CxW1: Days 1, 4
  • CxW2: Days 8, 11
  • CxW3: Days 15, 18
  • CxW4: Days 22, 25

Study treatment must commence within 3 days after randomization and continue up to 2 years or until disease progression (confirmed), unacceptable toxicity or patient withdrawal of consent.

In addition to Study Treatment, nivolumab is administered at specific doses on specific days as an intravenous infusion over approximately 30 minutes. Nivolumab will be administered on Day 1 of each cycle.

For non-randomized cohort for special population, eligible subjects will receive HBI-8000 30 mg oral BIW and nivolumab IV at specific doses on specific days, under the same schedule as described above. For adolescents weighing < 40 kg, nivolumab will be dosed at specific doses every 4 weeks. Nivolumab will be administered on Day 1 of each cycle.

Being tested
HBI-8000 in combination with nivolumab, Placebo in combination with nivolumab
Keywords
HBI-8000, nivolumab, melanoma, brain metastasis
Medical subject headings
Melanoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HBI-8000 in combination with nivolumabDrug

    Also called For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®

    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 nivolumabDrug

    Also called For nivolumab: OPDIVO®

    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.

Study groups in NCT04674683
Study groupRoleWhat they receive
Test ArmExperimentalHBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days
Receives: Drug: HBI-8000 in combination with nivolumab
Control ArmPlacebo comparatorPlacebo oral BIW + nivolumab IV at specific doses on specific days
Receives: Drug: Placebo in combination with nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome

    Progression-free Survival (PFS) defined as the time (in days) from the date of randomization to the first date of documented disease progression as determined by BIRC, or the date of death due to any cause, whichever occurs first.

    Measured: From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months

Secondary outcomes (3)

  1. Objective Response Rate

    Objective Response Rate (ORR) defined as the percentage of patients enrolled in each study arm with a best response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the blinded independent review committee (BIRC).

    Measured: From date of randomization until disease progression or unacceptable toxicity, assessed up to 48 months

  2. Overall Survival

    Overall Survival (OS) defined as the time from randomization date to the date of death due to any cause.

    Measured: From date of randomization to death due to any cause, assessed up to 48 months

  3. Safety, defined as the incidence rate of AEs

    Safety, defined as the incidence rate of AEs. The NCI-CTCAE v5.0 will serve as the reference document for choosing the appropriate terminology to grade the severity of AEs, and to assess the causal relationship and outcomes.

    Measured: From date of screening until the end of study, assessed up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start12 Aug 2021
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04674683
Sponsor's protocol ID
HBI-8000-303
Status last verified
Sep 2025
First submitted
7 Dec 2020
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HBI-8000 in combination with nivolumab in people with Unresectable or Metastatic Melanoma and Progressive Brain Metastasis, run by HUYABIO International, LLC. at 139 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Brazil, Germany, Spain, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04674683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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