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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)

Primary Purpose

Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Belzutifan
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pheochromocytoma/Paraganglioma focused on measuring HIF-2α, Pheochromocytoma/paraganglioma, Pancreatic NET

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Not amenable for surgery, radiation, locoregional therapies or combination modality of such treatments with curative intent.
    2. 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 and A2

  • 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.

    1. Irradiated lesions or lesions treated with locoregional therapies should not be used as target lesions unless they clearly demonstrate growth since completion of radiation.
    2. Metastatic lesions situated in the brain are not considered measurable and should be considered nontarget lesions.
    3. 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.
    4. 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.
  • 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:

    1. 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
    2. 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:

    1. Is not a WOCBP). OR
    2. 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.

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 PPGL for Cohort A1 and pNET for Cohort A2) are localized without immediate need for intervention.
  • 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 and Cohort A2, 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) with chemotherapy, targeted therapy, or other investigational therapy within the past 4 weeks of study entry, or prior biologics or immunotherapy within the past 6 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.

    1. 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.
    2. 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.

Sites / Locations

  • Cedars-Sinai Medical Center ( Site 0110)Recruiting
  • University of Iowa ( Site 0104)Recruiting
  • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( SiteRecruiting
  • Massachusetts General Hospital ( Site 0111)Recruiting
  • University of Michigan ( Site 0126)Recruiting
  • Washington University-Internal Medicine/Oncology ( Site 0124)Recruiting
  • Icahn School of Medicine at Mount Sinai ( Site 0123)Recruiting
  • Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)Recruiting
  • Vanderbilt University Medical Center ( Site 0107)Recruiting
  • University of Texas MD Anderson Cancer Center ( Site 0112)Recruiting
  • Prince of Wales Hospital-Medical Oncology ( Site 1601)Recruiting
  • The Royal Melbourne Hospital ( Site 1602)Recruiting
  • Tom Baker Cancer Center ( Site 0203)Recruiting
  • Princess Margaret Cancer Centre ( Site 0202)Recruiting
  • Peking University First Hospital-Urology ( Site 1900)Recruiting
  • Sun Yat-sen University Cancer Center ( Site 1905)Recruiting
  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)Recruiting
  • West China Hospital of Sichuan University ( Site 1906)Recruiting
  • Rigshospitalet-Department of Endocrinology ( Site 0303)Recruiting
  • Odense Universitetshospital ( Site 0302)Recruiting
  • CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)Recruiting
  • Institut Paoli-Calmettes-Oncology ( Site 0406)Recruiting
  • Gustave Roussy ( Site 0403)Recruiting
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)Recruiting
  • Hôpital Edouard Herriot-oncologie ( Site 0405)Recruiting
  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)Recruiting
  • Universitaetsklinikum Freiburg ( Site 0504)Recruiting
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (Recruiting
  • Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)Recruiting
  • Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( SiteRecruiting
  • Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)Recruiting
  • Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)Recruiting
  • University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)Recruiting
  • Ospedale San Raffaele-Oncologia Medica ( Site 0705)Recruiting
  • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)Recruiting
  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori NeuroeRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)Recruiting
  • Hokkaido University Hospital ( Site 1800)
  • Yokohama City University Hospital-Department of Urology ( Site 1804)
  • Kochi Medical School Hospital ( Site 1807)
  • National Cancer Center Hospital ( Site 1802)
  • Kyoto University Hospital ( Site 1806)
  • Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
  • Universitair Medisch Centrum Utrecht ( Site 1530)Recruiting
  • GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
  • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
  • Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
  • National Cancer Centre Singapore ( Site 1700)Recruiting
  • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)Recruiting
  • MD Anderson Cancer Center-Oncology ( Site 1102)
  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)Recruiting
  • Hospital Universitari Vall d'Hebron ( Site 1100)Recruiting
  • Skanes University Hospital Lund ( Site 1200)Recruiting
  • Karolinska Universitetssjukhuset Solna ( Site 1202)Recruiting
  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)Recruiting
  • Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)Recruiting
  • Ege University Medicine of Faculty ( Site 0900)Recruiting
  • Hacettepe Universitesi-oncology hospital ( Site 0901)Recruiting
  • Ankara Bilkent Şehir Hastanesi. ( Site 0904)Recruiting
  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)Recruiting
  • Addenbrooke's Hospital ( Site 1309)Recruiting
  • Royal Free Hospital ( Site 1302)
  • The Beatson West of Scotland Cancer Centre ( Site 1308)Recruiting
  • Hammersmith Hospital-Medical Oncology ( Site 1304)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belzutifan

Arm Description

Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Duration of Response (DOR) as Assessed by BICR
DOR is the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time to Response (TTR) as Assessed by BICR
TTR is defined as the time from first dose of belzutifan to first documented evidence of CR or PR.
Disease Control Rate (DCR) as Assessed by BICR
Disease control is a confirmed CR, PR, or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study).
Progressive Free Survival (PFS) as Assessed by BICR
PFS is the time from first dose of belzutifan to the first documented PD or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is the time from first dose of belzutifan until death from any cause.
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Drug due to an AE
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be presented.
Time to Surgery (TTS)
TTS is defined as the time from the first dose of belzutifan to the first documented surgical intervention or tumor reduction procedure.

Full Information

First Posted
June 8, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04924075
Brief Title
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)
Official Title
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) 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 HIF-2α Related Genetic Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
February 26, 2027 (Anticipated)
Study Completion Date
February 26, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Advanced Gastrointestinal Stromal Tumor, HIF-2α Mutated Cancers
Keywords
HIF-2α, Pheochromocytoma/paraganglioma, Pancreatic NET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Belzutifan
Arm Type
Experimental
Arm Description
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Intervention Type
Drug
Intervention Name(s)
Belzutifan
Other Intervention Name(s)
MK-6482, WELIREG™
Intervention Description
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Description
ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 5.5 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) as Assessed by BICR
Description
DOR is the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 5.5 years
Title
Time to Response (TTR) as Assessed by BICR
Description
TTR is defined as the time from first dose of belzutifan to first documented evidence of CR or PR.
Time Frame
Up to approximately 5.5 years
Title
Disease Control Rate (DCR) as Assessed by BICR
Description
Disease control is a confirmed CR, PR, or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study).
Time Frame
Up to approximately 5.5 years
Title
Progressive Free Survival (PFS) as Assessed by BICR
Description
PFS is the time from first dose of belzutifan to the first documented PD or death from any cause, whichever occurs first.
Time Frame
Up to approximately 5.5 years
Title
Overall Survival (OS)
Description
OS is the time from first dose of belzutifan until death from any cause.
Time Frame
Up to approximately 5.5 years
Title
Number of Participants Experiencing Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 5.5 years
Title
Number of Participants Discontinuing Study Drug due to an AE
Description
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 5.5 years
Title
Time to Surgery (TTS)
Description
TTS is defined as the time from the first dose of belzutifan to the first documented surgical intervention or tumor reduction procedure.
Time Frame
Up to approximately 5.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center ( Site 0110)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-967-2781
Facility Name
University of Iowa ( Site 0104)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-356-2148
Facility Name
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-502-5140
Facility Name
Massachusetts General Hospital ( Site 0111)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-724-4000
Facility Name
University of Michigan ( Site 0126)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
734-647-8902
Facility Name
Washington University-Internal Medicine/Oncology ( Site 0124)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-747-6268
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 0123)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-824-2385
Facility Name
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-615-1725
Facility Name
Vanderbilt University Medical Center ( Site 0107)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-811-8480
Facility Name
University of Texas MD Anderson Cancer Center ( Site 0112)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-792-2841
Facility Name
Prince of Wales Hospital-Medical Oncology ( Site 1601)
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61402035933
Facility Name
The Royal Melbourne Hospital ( Site 1602)
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61 3 9342 7143
Facility Name
Tom Baker Cancer Center ( Site 0203)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
403-521-3165
Facility Name
Princess Margaret Cancer Centre ( Site 0202)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
416-946-4501 Ext 6508
Facility Name
Peking University First Hospital-Urology ( Site 1900)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613910394281
Facility Name
Sun Yat-sen University Cancer Center ( Site 1905)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-87343088
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-53882350
Facility Name
West China Hospital of Sichuan University ( Site 1906)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 18608033400
Facility Name
Rigshospitalet-Department of Endocrinology ( Site 0303)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
35457562
Facility Name
Odense Universitetshospital ( Site 0302)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 66 11 33 33
Facility Name
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+(0)3 88 12 75 93
Facility Name
Institut Paoli-Calmettes-Oncology ( Site 0406)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0491223302
Facility Name
Gustave Roussy ( Site 0403)
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33142114211
Facility Name
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
City
Le Kremlin-Bicêtre
State/Province
Paris
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003345212380
Facility Name
Hôpital Edouard Herriot-oncologie ( Site 0405)
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33472119692
Facility Name
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33158411439
Facility Name
Universitaetsklinikum Freiburg ( Site 0504)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49761270-32613
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4989440052221
Facility Name
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49-(0)931-20 13 90 21
Facility Name
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930450614303
Facility Name
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3614591500
Facility Name
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972506844706
Facility Name
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
City
Naples
State/Province
Campania
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390817462132
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 0226435789
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390303995410
Facility Name
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390257489258
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390458128131
Facility Name
Hokkaido University Hospital ( Site 1800)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Yokohama City University Hospital-Department of Urology ( Site 1804)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kochi Medical School Hospital ( Site 1807)
City
Nankoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center Hospital ( Site 1802)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kyoto University Hospital ( Site 1806)
City
Kyoto
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
City
Tokyo
ZIP/Postal Code
123-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Universitair Medisch Centrum Utrecht ( Site 1530)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31887556308
Facility Name
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
190020
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117036
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National Cancer Centre Singapore ( Site 1700)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
64368000
Facility Name
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34646662756
Facility Name
MD Anderson Cancer Center-Oncology ( Site 1102)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34913908926
Facility Name
Hospital Universitari Vall d'Hebron ( Site 1100)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34934894350
Facility Name
Skanes University Hospital Lund ( Site 1200)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4646171000
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 1202)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46851770000
Facility Name
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46186110000
Facility Name
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46313421000
Facility Name
Ege University Medicine of Faculty ( Site 0900)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00902323903911
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 0901)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00903123052910
Facility Name
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0090312 552 60 00
Facility Name
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00905324167355
Facility Name
Addenbrooke's Hospital ( Site 1309)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441223245151
Facility Name
Royal Free Hospital ( Site 1302)
City
London
State/Province
England
ZIP/Postal Code
NW32QG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
The Beatson West of Scotland Cancer Centre ( Site 1308)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 141 301 7055
Facility Name
Hammersmith Hospital-Medical Oncology ( Site 1304)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0208 383 3089

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=6482-015&&kw=6482-015
Description
Plain Language Summary

Learn more about this 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)

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