Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PT2385-202 | Other Identifier | Peloton Study ID | |
| MK-3795-003 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL participants treated with MK-3795.
This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of MK-3795 in participants with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). MK-3795 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-3795 | Experimental | Participants receive 800 mg MK-3795 orally twice daily. Participants may continue to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-3795 | Drug | 800 mg twice daily (four 200 mg oral tablets twice daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors | ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis. | Up to approximately 76 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors | PFS was defined as the interval from the start of study treatment to the first documented Progressive Disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34783716 | Derived | Larcher A, Rowe I, Belladelli F, Fallara G, Raggi D, Necchi A, Montorsi F, Capitanio U, Salonia A; OSR VHL Program. Von Hippel-Lindau disease-associated renal cell carcinoma: a call to action. Curr Opin Urol. 2022 Jan 1;32(1):31-39. doi: 10.1097/MOU.0000000000000950. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK-3795 | Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2022 |
Not provided
This is an open-label Phase 2 study that will be conducted with a 2-stage design.
Not provided
Not provided
Not provided
Not provided
| Up to approximately 76 months |
| Duration of Response (DOR) in VHL Disease-Associated ccRCC Tumors | DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | Up to approximately 76 months |
| Time to Response (TTR) in VHL Disease-Associated ccRCC Tumors | TTR was defined as the interval from the start of study treatment to the first documentation of a response per RECIST 1.1, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). | Up to approximately 76 months |
| Overall Response Rate (ORR) in VHL Disease-Associated Non-ccRCC Tumors | ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | Up to approximately 76 months |
| Progression-free Survival (PFS) in VHL Disease-Associated Non-ccRCC Tumors | PFS was defined as the interval from the start of study treatment to the first documented PD or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | Up to approximately 76 months |
| Duration of Response (DOR) in VHL Disease-Associated Non-ccRCC Tumors | DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | Up to approximately 76 months |
| Time to Response (TTR) in VHL Disease-Associated Non-ccRCC Tumors | TTR was defined as the interval from the start of study treatment to the first documentation of a response per RECIST 1.1, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). | Up to approximately 76 months |
| MK-3795 Plasma Concentration | Blood samples for the determination of MK-3795 concentration were collected at pre-specified timepoints before and after administration of study intervention. | Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose |
| MK-3795 Metabolite Plasma Concentration | Blood samples for the determination of MK-3795 metabolite concentration were collected at pre-specified timepoints before and after administration of study intervention. | Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. | Up to approximately 76 months |
| Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. | Up to approximately 74 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-3795 | Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors | ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 76 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors | PFS was defined as the interval from the start of study treatment to the first documented Progressive Disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in VHL Disease-Associated ccRCC Tumors | DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | The analysis population consisted of all allocated participants who received at least one dose of study intervention and experienced CR or PR. No participants experienced CR or PR and DOR was not analyzed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) in VHL Disease-Associated ccRCC Tumors | TTR was defined as the interval from the start of study treatment to the first documentation of a response per RECIST 1.1, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). | The analysis population consisted of all allocated participants who received at least one dose of study intervention and experienced CR or PR. No participants experienced CR or PR and TTR was not analyzed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) in VHL Disease-Associated Non-ccRCC Tumors | ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in VHL Disease-Associated Non-ccRCC Tumors | PFS was defined as the interval from the start of study treatment to the first documented PD or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in VHL Disease-Associated Non-ccRCC Tumors | DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. | There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) in VHL Disease-Associated Non-ccRCC Tumors | TTR was defined as the interval from the start of study treatment to the first documentation of a response per RECIST 1.1, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). | There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed. | Posted | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||||
| Secondary | MK-3795 Plasma Concentration | Blood samples for the determination of MK-3795 concentration were collected at pre-specified timepoints before and after administration of study intervention. | The analysis population consisted of all allocated participants who received at least one dose of study intervention and had available MK-3475 plasma concentration data at the specified timepoints. No participants had available MK-3475 plasma concentration data at Week 17. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose |
|
| ||||||||||||||||||||||||||
| Secondary | MK-3795 Metabolite Plasma Concentration | Blood samples for the determination of MK-3795 metabolite concentration were collected at pre-specified timepoints before and after administration of study intervention. | The analysis population consisted of all allocated participants who received at least one dose of study intervention and had available MK-3475 metabolite plasma concentration data at the specified timepoints. No participants had available MK-3475 metabolite plasma concentration data at Week 17. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 76 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. | The analysis population consisted of all allocated participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 74 months |
|
|
Up to approximately 76 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-3795 | Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression. | 0 | 4 | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphasia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster cutaneous disseminated | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Mammogram abnormal | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
The Sponsor reserves the right to review all planned communications and manuscripts based on the results of this study. This reservation of right is not intended to restrict or hinder publication of any dissemination of study results, but to allow the Sponsor to confirm the accuracy of the data, to protect proprietary information, and to provide comments based on information that may not yet be available to the study Investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Aug 28, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006623 | von Hippel-Lindau Disease |
| D002292 | Carcinoma, Renal Cell |
| 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 |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614279 | PT2385 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|