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New combo aims to boost immune attack on tough melanoma

NCT ID NCT04674683

Disease control Sponsor: HUYABIO International, LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tests whether adding HBI-8000 to the immunotherapy nivolumab helps people with advanced melanoma that has not been treated with similar drugs. About 450 participants will receive either the combo or a placebo plus nivolumab. The study also includes a separate group for patients with new or worsening brain metastases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HBI-8000 (tucidinostat) combined with nivolumab (Opdivo)
What this could lead to
If successful, this combination could offer a new treatment option that helps control advanced melanoma for longer than nivolumab alone.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet confirmed. The combination may not improve outcomes and could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain cancer melanoma metastatic malignant neoplasm in the brain metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Progressive brain metastasis Unresectable or metastatic melanoma

Contacts and locations

Locations

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

    Perugia, Perugia, 06132, Italy

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

    Siena, 53100, Italy

  • AMR Kansas City

    Kansas City, Missouri, 64114, United States

  • AZ Klina

    Brasschaat, 2930, Belgium

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Affinity Clinical Research

    Nedlands, Australia

  • AnMed Health

    Anderson, South Carolina, 29621, United States

  • Ascension Sacred Heart Medical Oncology

    Pensacola, Florida, 32504, United States

  • Auckland City Hospital

    Auckland, New Zealand

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138, Italy

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

    Palermo, 90127, Italy

  • Ballarat Health Services

    Ballarat, Victoria, Australia

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Boca Raton Regional Hospital, Lynn Cancer Institute

    Boca Raton, Florida, 33486, United States

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

    Santo André, São Paulo, 09060-650, Brazil

  • CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie

    Lille, France

  • CHU Grenoble Alpes

    La Tronche, France

  • CHU de Besançon - Hôpital Jean MINJOZ

    Besançon, France

  • CHU de Dijon, Service de dermatologie

    Dijon, France

  • CHU de Rouen-Hôpital

    Rouen, 76031, France

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

    San Marcos, California, 92069, United States

  • Calvary Mater Newcastle

    Waratah, Australia

  • Cancercare Rondebosch Oncology

    Rondebosch, Western Cape, 7700, South Africa

  • Cape Town Oncology Trials Cape Gate Oncology Centre

    Kraaifontein, Western Cape, 7570, South Africa

  • Carolina Blood and Cancer Care Associates

    Lancaster, South Carolina, 29720, United States

  • Catalan Institute of Oncology

    Barcelona, 08908, Spain

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centro Gaúcho Integrado de Oncologia, Hematologia

    Porto Alegre, Rio Grande do Sul, 90850-170, Brazil

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Cha University Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117, Germany

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Chungnam National University Hospital

    Daejeon, Jung-gu, 35015, South Korea

  • Clinique Saint-Pierre

    Ottignies, 1340, Belgium

  • Cliniques Universitaires

    Brussels, 1200, Belgium

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309, United States

  • Curo Oncology

    Pretoria, Gauteng, 0084, South Africa

  • Edinburgh Cancer Center Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Emad Ibrahim, MD, INC

    Redlands, California, 92373, United States

  • Ensino e Terapia de Inovação Clίnica AMO-ETICA

    Salvador, Estado de Bahia, 41950-610, Brazil

  • Excellentis Clinical Trial Consultants

    George, Western Cape, 6529, South Africa

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034, Czechia

  • Fakultni nemocnice Olomoue

    Olomouc, 77900, Czechia

  • Fakultni nemocnice Ostrava Kozni oddeleni

    Ostrava-Poruba, 70852, Czechia

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

    Milan, Milano, 20122, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Milano, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Frederick Memorial Healthcare System

    Frederick, Maryland, 21701, United States

  • Froedtert Hospital, Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Fundação Doutor Amaral Carvalho

    Jaú, São Paulo, 17210-080, Brazil

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

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

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526, United States

  • Goulburn Valley Health

    Shepparton, Victoria, Australia

  • Helios Klinikum Erfurt, Dermatologie und Allergologie

    Erfurt, 99089, Germany

  • Hopital de Câncer de Barretos-Fundação Pio XII

    Barretos, São Paulo, 14784-400, Brazil

  • Hospial Oncologico, Puerto Rico Medical Center

    Rio Piedras, Puerto Rico, 00935, Puerto Rico

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-010, Brazil

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

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

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • Hospital São Vicente de Paulo

    Centro, Rio Grande do Sul, 99010-080, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario Fundación Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital de Clίnίcas de Porto Alegre

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

  • Hospital de la Citadelle

    Liège, 4000, Belgium

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520, Brazil

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

    Misterbianco, 95045, Italy

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, France

  • Hôpital La Timone

    Marseille, 13385 Cedex 05, France

  • Hôpital Saint-Louis

    Paris, France

  • ICO Badalona-Hospital Universitari Germans Trias I Pujol

    Barcelona, 08916, Spain

  • IRCCS Giovanni Paolo II Oncologia Medica

    Bari, 70124, Italy

  • Icon Cancer Centre Wesley

    South Brisbane, Queensland, Australia

  • Innovative Clinical Research Institute (ICRI)

    Pasadena, California, 91105, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Gustave Roussy, Service de Dermatologie

    Villejuif, France

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

    São Paulo, São Paulo, 01246-000, Brazil

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

    Naples, 80131, Italy

  • Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Kaiser Permanente Oncology Research

    Riverside, California, 92505, United States

  • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

    Leipzig, 04103, Germany

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Liverpool Hospital

    Liverpool, Australia

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Medical University of Graz Department of Dermatology and Venerology

    Graz, 8036, Austria

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Memorial Regional Hospital

    Hollywood, Florida, 33021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Centre

    Singapore, 169610, Singapore

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Hospital Organization Osaka National Hospital

    Chuo Ku, Osaka, 540-0006, Japan

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566, Japan

  • Nuffield Health Wessex Hospital

    Eastleigh, Hampshire, SO53 2DW, United Kingdom

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oncosite-Centro de Pesquisa Clίnica em Oncologia

    São Cristóvão, Rio Grande do Sul, 98700-000, Brazil

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

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

    Verona, 37134, Italy

  • Renovatio Clinical

    The Woodlands, Texas, 77380, United States

  • Royal Brisband and Women's Hospital

    Brisbane, Australia

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Severance Hospital Younsei University Health System,

    Seoul, Gyeonggi-do, 03722, South Korea

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621, Japan

  • Shizuoka Cancer Center

    Nagaizumi-cho, Sunto-gun, 411-8777, Japan

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534, United States

  • St Louis Cancer Care

    Bridgeton, Missouri, 63044, United States

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • St. Vincent - Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, Australia

  • Tauranga Hospital

    Tauranga, 3112, New Zealand

  • The Cancer Institute Hospital of JFCR

    Kōtoku, Tokho, 135-8550, Japan

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196, South Africa

  • Thomas Jefferson University Medical Oncology Clinic

    Philadelphia, Pennsylvania, 19107, United States

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623, United States

  • Tweed Hospital

    Tweed Heads, Australia

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • Univ.-Lkinik für Dermatologie, Venerologie und Allergologie

    Innsbruck, 6020, Austria

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

    Dresden, 01307, Germany

  • Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie

    Freiburg im Breisgau, 79104, Germany

  • Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln, Dermatologie und Venerologie,

    Cologne, 50937, Germany

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

    Mannheim, 68167, Germany

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    Lübeck, 23538, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik

    Mainz, 55131, Germany

  • Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz

    Essen, Germany

  • University of the Sunshine Coast

    Buderim, Queensland, 4556, Australia

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Vivantes Klinikum Spandau, Dermatologie und Allergologie

    Berlin, 13585, Germany

  • Waikato Hospital

    Hamilton, New Zealand

  • West Rand Oncology Centre Flora Clinic

    Roodepoort, Gauteng, 1709, South Africa

  • Wilgers Oncology Centre

    Pretoria, Gauteng, 0081, South Africa

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