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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1325-4582 | Registry Identifier | UTN | |
| 2025-524160-38-00 | Registry Identifier | EU CT | |
| MK-6482-043 | Other Identifier | MSD | |
| jRCT2061260008 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:
Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Belzutifan Monotherapy | Experimental | Participants on active treatment assigned to belzutifan monotherapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Cohort B: Belzutifan Combination Therapy | Experimental | Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Cohort C: Non-Belzutifan Therapy | Active Comparator | Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belzutifan | Drug | Belzutifan is administered orally at 120 mg once daily (qd) OR 200 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A and Cohort B: Overall Survival (OS) | Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause. | Up to approximately 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AE) | An AE was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study. | Up to approximately 2 years |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center ( Site 0107) | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Nivolumab | Drug | Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Lenvatinib | Drug | Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Cabozantinib | Drug | Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
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| Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study. | Up to approximately 2 years |
| Dana-Farber Cancer Institute ( Site 0105) | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Karmanos Cancer Center ( Site 0108) | Recruiting | Detroit | Michigan | 48201 | United States |
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| Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| SCRI Oncology Partners ( Site 7000) | Recruiting | Nashville | Tennessee | 37203 | United States |
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| START San Antonio ( Site 0104) | Recruiting | San Antonio | Texas | 78229 | United States |
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| Fred Hutchinson Cancer Center ( Site 0106) | Recruiting | Seattle | Washington | 98109 | United States |
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| St George Hospital-Oncology Clinical Research Unit ( Site 2701) | Recruiting | Kogarah | New South Wales | 2217 | Australia |
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| UZ Leuven ( Site 0900) | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| Département clinique de médecine de laboratoire du CHUM ( Site 0001) | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| CIDO SpA ( Site 0305) | Recruiting | Temuco | Araucania | 4810148 | Chile |
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| FALP ( Site 0300) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Oncovida ( Site 0303) | Recruiting | Santiago | Region M. de Santiago | 7500994 | Chile |
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| ONCOCENTRO APYS ( Site 0302) | Recruiting | Viña del Mar | Valparaiso | 2520598 | Chile |
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| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) | Recruiting | Olomouc | 77900 | Czechia |
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| Herlev and Gentofte Hospital ( Site 1200) | Recruiting | Herlev | Capital Region | 2370 | Denmark |
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| Tampereen yliopistollinen sairaala ( Site 1305) | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
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| Hôpitaux Universitaires de Strasbourg ( Site 1702) | Recruiting | Strasbourg | Bas-Rhin | 67200 | France |
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| Institut Claudius Regaud ( Site 1703) | Recruiting | Toulouse | Haute-Garonne | 31059 | France |
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| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501) | Recruiting | Budapest | 1122 | Hungary |
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| Rambam Health Care Campus ( Site 1600) | Recruiting | Haifa | 3109601 | Israel |
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| Hadassah Medical Center ( Site 1604) | Recruiting | Jerusalem | 9112001 | Israel |
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| Rabin Medical Center ( Site 1602) | Recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical center ( Site 1601) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Sourasky Medical Center ( Site 1603) | Recruiting | Tel Aviv | 64239 | Israel |
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| Kyushu University Hospital ( Site 3101) | Recruiting | Fukuoka | 812-8582 | Japan |
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| Isala, locatie Zwolle ( Site 1902) | Recruiting | Zwolle | Overijssel | 8025 AB | Netherlands |
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| Auckland City Hospital ( Site 3000) | Recruiting | Auckland | 1023 | New Zealand |
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| Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 2000) | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
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| N.N. Blokhin NMRCO ( Site 2101) | Active, not recruiting | Moscow | Moscow | 115478 | Russia |
| Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100) | Active, not recruiting | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Samsung Medical Center ( Site 2902) | Recruiting | Gangnam | Seoul | 06351 | South Korea |
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| Severance Hospital, Yonsei University Health System ( Site 2901) | Recruiting | Seodaemun-gu | Seoul | 03722 | South Korea |
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| Asan Medical Center ( Site 2900) | Recruiting | Seoul | 05505 | South Korea |
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| Hospital Universitari Vall d'Hebron ( Site 2300) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 2301) | Recruiting | Madrid | 28041 | Spain |
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| Taipei Veterans General Hospital ( Site 2800) | Active, not recruiting | Taipei | 11217 | Taiwan |
| ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601) | Active, not recruiting | Dnipropetrovsk | Dnipropetrovsk Oblast | 49005 | Ukraine |
| CNCE Precarpathian Clinical Oncologic Center ( Site 2600) | Active, not recruiting | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| The Beatson West of Scotland Cancer Centre ( Site 2505) | Recruiting | Glasgow | Glasgow City | G12 0YN | United Kingdom |
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| St Bartholomew's Hospital ( Site 2500) | Recruiting | London | London, City of | EC1A 7BE | United Kingdom |
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| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502) | Recruiting | London | London, City of | SW3 6JJ | United Kingdom |
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| Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504) | Recruiting | London | London, City of | W6 8RF | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 2501) | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D006623 | von Hippel-Lindau Disease |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072661 | Ciliopathies |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C000720612 | belzutifan |
| D000077594 | Nivolumab |
| C531958 | lenvatinib |
| C558660 | cabozantinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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