Von Hippel-Lindau Disease Clinical Trial

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Summary

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cohort A1: Pheochromocytoma/Paraganglioma (PPGL)

- Has documented histopathological diagnosis (local report) of pheochromocytoma or paraganglioma Note: Participants are allowed to receive therapy in first line where a satisfactory treatment option does not exist and if participants are not candidates for systemic chemotherapy or have refused such therapy. There is no limit on number of prior systemic therapies.

Locoregional therapies or adjuvant/neoadjuvant therapies are not considered a line of prior systemic therapy

Has locally advanced or metastatic disease that is not amenable to surgery or curative intent treatment
Has adequately controlled blood pressure defined as blood pressure ≤150/90 mm Hg (≤135/85 mm Hg for adolescents) and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.

Cohort A2: Pancreatic Neuroendocrine Tumor (pNET)

Has documented histopathological or cytopathological diagnosis (local report) of well-differentiated, low, or intermediate grade (G1 or G2 pNET per 2017 World Health Organization (WHO) classification and grading) pNET.

Has locally advanced disease or metastatic disease that is:

Not amenable for surgery, radiation, locoregional therapies or combination modality of such treatments with curative intent.
Experienced disease progression on or after at least 1 line of prior systemic therapy that includes an approved targeted agent such as everolimus or sunitinib. Participants who have received >3 prior systemic therapies will be capped to ≤20% of the cohort.

Note: Chemoembolization/radiofrequency ablation/locoregional therapies, neoadjuvant/adjuvant treatments, or somatostatin analog monotherapy or interferon monotherapy will not count as 1 line of prior systemic therapy.

Cohorts A1, A2 and PPGL/pNET participants from Cohort D

Has disease progression within the past 12 months from Screening.

Has measurable disease per RECIST 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by local site investigator/radiology assessment and verified by BICR.

Irradiated lesions or lesions treated with locoregional therapies should not be used as target lesions unless they clearly demonstrate growth since completion of radiation.
Metastatic lesions situated in the brain are not considered measurable and should be considered nontarget lesions.
Only lesions of the primary indication for the cohort may be evaluated for measurability; other neoplastic lesions will be documented by the investigator and this information provided to the independent reviewers to ensure that such lesions are not included in the RECIST assessment.
Participants who are adolescents (12-17 years of age) need to have a body weight of 40 kilograms (kg) or more.

Cohort B1: von Hippel-Lindau (VHL) Disease-Associated Tumors

Have a diagnosis of VHL disease as determined by a germline test (documented germline VHL gene alteration) locally and/or clinical diagnosis.
Have at least 1 measurable PPGL or pNET per RECIST 1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified by BICR.
Participants from China or Japan defined as participants of Chinese or Japanese origin residing in mainland China or Japan respectively at the time of Screening, must have at least 1 measurable RCC or PPGL or pNET per RECIST 1.1 as assessed by local site investigator/radiology assessment and verified by BICR.
Must be ≥18 years of age.

For Cohort B1 participants with PPGL

Must not have pheochromocytoma >5 cm or paraganglioma >4 cm that requires immediate surgery.
Have adequately controlled blood pressure defined as blood pressure ≤150/90 mm Hg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 2 weeks prior to start of study treatment.
Must not have Metastatic or locally advanced, unresectable PPGL.
Presence of concomitant VHL disease-associated tumors is permitted as long as they do not require immediate surgery or intervention.

For Cohort B1 participants with pNET:

Must not have lesion(s) located in the head of the pancreas must be >2 cm that requires immediate surgery.
Must not have lesion(s) located in the body or tail of the pancreas must be >3 cm that requires immediate surgery.
Must not have locally advanced, unresectable or metastatic pNET.
Presence of concomitant VHL disease-associated tumors is permitted as long as they do not require immediate surgery or intervention.

For Cohort B1 participants with renal cell carcinoma (RCC):

Must not have lesion(s) >3 cm that requires immediate surgery.
Must not have metastatic RCC.
Presence of concomitant VHL disease-associated tumors is permitted as long as they do not require immediate surgery or intervention.

For Cohort C participants with GIST (wt):

Has documented histopathological diagnosis of GIST.
Local test report documenting the absence of sensitizing mutations in both platelet derived growth factor receptor alpha (PDGFRA) and receptor tyrosine kinase (c-KIT).
Has locally advanced or metastatic disease that is not amenable to surgery or curative intent treatment.

For Cohort D participants with advanced solid tumors with HIF-2α related genetic alterations:

Local test report documenting germline or somatic mutations in at least one of the HIF-2α related genes.
Has locally advanced or metastatic solid tumor that is not amenable to surgery or curative intent treatment.
Has progressed on/after standard therapy for advanced/metastatic disease.

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:

Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:

i. Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman/women of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.

A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

Is not a WOCBP OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), for at least 30 days after the last dose of study intervention.
Submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (not previously irradiated). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue if the lesion is accessible and a biopsy is not clinically contraindicated.

Note: If participant has only 1 measurable lesion per RECIST 1.1, the biopsy specimen should be obtained from a nontarget lesion or archival tissue. Bone biopsies should not be submitted.

Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
Has adequate organ function.
Has a life expectancy of at least 3 months.

Exclusion Criteria:

Is unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the following exceptions:

Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.

Participants with history of VHL disease (germline VHL mutation documented by a local test report or with clinical diagnosis) will be permitted provided concurrent lesions (other than the tumor type being assessed such as PPGL for Cohort A1 and pNET for Cohort A2) are localized without immediate need for intervention. Cohort D participants with VHL disease will not be eligible.
Prior history of surgical resection(s) for concurrent localized VHL disease-associated tumors is allowed provided there is no history of metastatic disease from concurrent tumors; history of systemic therapy for concurrent tumors will be exclusionary.
Participants with history of other genetic syndromes (such as those with succinate dehydrogenase subunit genes (SDHx) germline mutation or multiple endocrine neoplasia/MEN) will be allowed provided concurrent tumors (outside of the organ affected in Cohort A1, Cohort A2, C and D respectively) are localized and do not require immediate intervention; history of metastatic disease in concurrent tumors or history of systemic therapy for concurrent tumors will be exclusionary.
Cohort B1 participants with concomitant central nervous system (CNS) hemangioblastoma must not require immediate surgery or intervention and must not be at risk of imminent neurological complications.
Cohort B1 participants with concomitant retinal angiomas/retinal hemangioblastomas must not require immediate intervention.
Cohort B1 participants with any concomitant tumors must not require immediate surgery or intervention.
For Cohort B1 participants, history of any anticancer systemic therapy (including investigational agents) for any VHL disease-associated tumor or history of metastatic disease from any VHL disease-associated tumor or other non-VHL disease-related tumor(s) will be exclusionary.
Has known CNS metastases and/or carcinomatous meningitis.
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Concurrent uncontrolled hypertension defined as blood pressure >150/90 mm mercury (Hg) despite optimal antihypertensive medications within 2 weeks prior to the first dose of study treatment.

Note: Medically controlled arrhythmia stable on medication is permitted.

Has any of the following: A pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
Has had major surgery ≤4 weeks prior to first dose of study intervention.
Has received prior treatment (except somatostatin analogs for pNET participants) with chemotherapy, targeted therapy, biologics or other investigational therapy within the past 4 weeks of first dose of study intervention.
Has received prior locoregional therapies or radiation within the past 4 weeks of first dose of study intervention.
Has received prior treatment with Peptide Receptor Radionuclide Therapy (PRRT)/radionuclide therapy (such as 177Lu-Dotatate) or other radiopharmaceutical therapy within the past 12 weeks from Screening for participants with pNET.
Has received meta-iodobenzylguanidine (MIBG) therapy or other radiopharmaceutical therapy within the past 12 weeks from Screening for participants with PPGL.
Has received prior treatment with any HIF-2α inhibitor (including belzutifan).
Has a known hypersensitivity to the study treatment and/or any of its excipients.
Has toxicities from prior locoregional or systemic or any other therapies that is not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤Grade 1 (with the exception of alopecia).
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), or recombinant Erythropoietin (EPO) ≤28 days prior to the first dose of study intervention.
Is currently receiving strong inhibitors of Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study.
Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.
Is currently enrolled in and receiving study therapy, was enrolled in a study of an investigational agent, and received study therapy or used an investigational device within 4 weeks (28 days) of the first dose of study intervention.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of hepatitis B or known active hepatitis C (HCV) infection.

For Cohort A2, has a tumor histology consistent with poorly differentiated pNET, neuroendocrine carcinoma, or neuroendocrine tumor (NET) of nonpancreatic origin.

Poorly differentiated or high grade pancreatic pNET or pancreatic neuroendocrine carcinoma; mixed adenoneuroendocrine carcinoma of the pancreas or concurrent pancreatic ductal adenocarcinoma will not be allowed.
Neuroendocrine tumor of nonpancreatic origin such as gastrointestinal, lung/thoracic, unknown primary, or other organs (including adenocarcinoid/goblet cell carcinoid/small cell carcinoma/large cell carcinoma). Note: Neuroendocrine carcinoma of any origin is exclusionary.
For Cohort A2, participants who have uncontrolled symptoms from functional pNETs at study entry.
Has had an allogenic tissue/solid organ transplant.
For Cohort B1 participants, metastatic disease identified at Screening.
For Cohort C and GIST participants, clinically significant active bleeding (such as gastrointestinal [GI] bleeding), perforation, obstruction, and other disease-related complications, requiring emergency surgery.
For Cohort D participants, VHL disease is exclusionary.

Study is for people with:

Von Hippel-Lindau Disease

Phase:

Phase 2

Estimated Enrollment:

322

Study ID:

NCT04924075

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 66 Locations for this study

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Cedars-Sinai Medical Center ( Site 0110)
Los Angeles California, 90048, United States More Info
Study Coordinator
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310-967-2781
University of Iowa ( Site 0104)
Iowa City Iowa, 52242, United States More Info
Study Coordinator
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319-356-2148
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site
Baltimore Maryland, 21287, United States More Info
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410-502-5140
National Institute of Health ( Site 0125)
Bethesda Maryland, 20892, United States More Info
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240-858-3851
Massachusetts General Hospital ( Site 0111)
Boston Massachusetts, 02114, United States More Info
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617-724-4000
University of Michigan ( Site 0126)
Ann Arbor Michigan, 48109, United States More Info
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734-647-8902
Washington University-Internal Medicine/Oncology ( Site 0124)
Saint Louis Missouri, 63110, United States More Info
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314-747-6268
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York New York, 10029, United States More Info
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212-824-2385
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia Pennsylvania, 19104, United States More Info
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215-615-1725
Vanderbilt University Medical Center ( Site 0107)
Nashville Tennessee, 37232, United States More Info
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800-811-8480
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston Texas, 77030, United States More Info
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713-792-2841
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick New South Wales, 2031, Australia More Info
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+61402035933
The Royal Melbourne Hospital ( Site 1602)
Parkville Victoria, 3050, Australia More Info
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+61 3 9342 7143
Tom Baker Cancer Center ( Site 0203)
Calgary Alberta, T2N 4, Canada More Info
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Contact
403-521-3165
Princess Margaret Cancer Centre ( Site 0202)
Toronto Ontario, M5G 2, Canada More Info
Study Coordinator
Contact
416-946-4501 Ext 6508
Peking University First Hospital-Urology ( Site 1900)
Beijing Beijing, 10003, China
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou Guangdong, 51070, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai Shanghai, , China
West China Hospital of Sichuan University ( Site 1906)
Cheng Du Sichuan, 61004, China More Info
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+86 18608033400
Rigshospitalet ( Site 0304)
Copenhagen Hovedstaden, 2100, Denmark More Info
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+45 35456353
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen Hovedstaden, 2100, Denmark More Info
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35457562
Odense Universitetshospital ( Site 0302)
Odense Syddanmark, 5000, Denmark More Info
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+45 66 11 33 33
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg Alsace, 67098, France More Info
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+(0)3 88 12 75 93
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille Bouches-du-Rhone, 13009, France More Info
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0491223302
Gustave Roussy ( Site 0403)
Villejuif Ile-de-France, 94805, France More Info
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+33142114211
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre Paris, 94270, France More Info
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003345212380
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon Rhone-Alpes, 69003, France More Info
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+33472119692
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris , 75014, France More Info
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+33158411439
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg Baden-Wurttemberg, 79106, Germany More Info
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+49761270-32613
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (
München Bayern, 80336, Germany More Info
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+4989440052221
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg Bayern, 97080, Germany More Info
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+49-(0)931-20 13 90 21
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site
Berlin , 10117, Germany More Info
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+4930450614303
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest , 1083, Hungary More Info
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+3614591500
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan , 52621, Israel More Info
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+972506844706
Sourasky Medical Center ( Site 1401)
Tel Aviv , 64239, Israel More Info
Study Coordinator
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97236973082
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples Campania, 80100, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milano Lombardia, 20132, Italy More Info
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+39 0226435789
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia , 25123, Italy More Info
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+390303995410
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe
Milano , 20141, Italy More Info
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+390257489258
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
Verona , 37134, Italy More Info
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+390458128131
Hokkaido University Hospital ( Site 1800)
Sapporo Hokkaido, 060-8, Japan
Yokohama City University Hospital-Department of Urology ( Site 1804)
Yokohama Kanagawa, 236-0, Japan
Kochi Medical School Hospital ( Site 1807)
Nankoku Kochi, 783-8, Japan
National Cancer Center Hospital ( Site 1802)
Chuo-ku Tokyo, 104-0, Japan
Kyoto University Hospital ( Site 1806)
Kyoto , , Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo , 123-8, Japan
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht , 3584 , Netherlands More Info
Study Coordinator
Contact
31887556308
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa Baskortostan, Respublika, 45005, Russian Federation
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
Saint Petersburg Leningradskaya Oblast, 19002, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg Leningradskaya Oblast, 19825, Russian Federation
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow Moskva, 11552, Russian Federation
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow Moskva, 11703, Russian Federation
National Cancer Centre Singapore ( Site 1700)
Singapore Central Singapore, 16858, Singapore More Info
Study Coordinator
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64368000
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo Asturias, 33011, Spain More Info
Study Coordinator
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34646662756
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid Madrid, Comunidad De, 28033, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid Madrid, Comunidad De, 28041, Spain More Info
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34913908926
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona , 08035, Spain More Info
Study Coordinator
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34934894350
Skanes University Hospital Lund ( Site 1200)
Lund Skane Lan, 221 8, Sweden More Info
Study Coordinator
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+4646171000
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm Stockholms Lan, 171 7, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala Uppsala Lan, 751 8, Sweden More Info
Study Coordinator
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+46186110000
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg Vastra Gotalands Lan, 413 4, Sweden More Info
Study Coordinator
Contact
+46313421000
Ege University Medicine of Faculty ( Site 0900)
Bornova Izmir, 35100, Turkey More Info
Study Coordinator
Contact
00902323903911
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
00903123052910
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara , 06800, Turkey More Info
Study Coordinator
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0090312 552 60 00
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul , 34668, Turkey More Info
Study Coordinator
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00905324167355
Addenbrooke's Hospital ( Site 1309)
Cambridge Cambridgeshire, CB2 2, United Kingdom More Info
Study Coordinator
Contact
+441223245151
Royal Free Hospital ( Site 1302)
London England, NW32Q, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow Glasgow City, G12 0, United Kingdom More Info
Study Coordinator
Contact
+44 141 301 7055
Hammersmith Hospital-Medical Oncology ( Site 1304)
London London, City Of, W12 O, United Kingdom More Info
Study Coordinator
Contact
0208 383 3089

How clear is this clinincal trial information?

Study is for people with:

Von Hippel-Lindau Disease

Phase:

Phase 2

Estimated Enrollment:

322

Study ID:

NCT04924075

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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