Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
NCT ID: NCT04674683
Last Updated: 2025-09-24
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2021-08-12
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test Arm
HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days
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.
Control Arm
Placebo oral BIW + nivolumab IV 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
HUYABIO International, LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Gloria Lee, MD, PhD
Role: STUDY_DIRECTOR
HUYABIO International, LLC.
Locations
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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
Napoli, , 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
Countries
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Related Links
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MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab
Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma
U.S. FDA Resources
Other Identifiers
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HBI-8000-303
Identifier Type: -
Identifier Source: org_study_id
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