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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04924075
Registration number
NCT04924075
Ethics application status
Date submitted
8/06/2021
Date registered
11/06/2021
Date last updated
7/06/2024
Titles & IDs
Public 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-2a Related Genetic Alterations (MK-6482-015)
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Scientific 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-2a Related Genetic Alterations
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Secondary ID [1]
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MK-6482-015
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Secondary ID [2]
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6482-015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pheochromocytoma/Paraganglioma
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Pancreatic Neuroendocrine Tumor
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Von Hippel-Lindau Disease
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Advanced Gastrointestinal Stromal Tumor
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HIF-2a Mutated Cancers
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Stomach
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Cancer
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Bowel - Small bowel (duodenum and ileum)
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
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Pancreatic
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Metabolic and Endocrine
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Other endocrine disorders
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Belzutifan
Experimental: Belzutifan - Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Treatment: Drugs: Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 5.5 years
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Secondary outcome [1]
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Duration of Response (DOR) as Assessed by BICR
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Assessment method [1]
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DOR is the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to approximately 5.5 years
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Secondary outcome [2]
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Time to Response (TTR) as Assessed by BICR
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Assessment method [2]
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TTR is defined as the time from first dose of belzutifan to first documented evidence of CR or PR.
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Timepoint [2]
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Up to approximately 5.5 years
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Secondary outcome [3]
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Disease Control Rate (DCR) as Assessed by BICR
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Assessment method [3]
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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).
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Timepoint [3]
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Up to approximately 5.5 years
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Secondary outcome [4]
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Progressive Free Survival (PFS) as Assessed by BICR
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Assessment method [4]
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PFS is the time from first dose of belzutifan to the first documented PD or death from any cause, whichever occurs first.
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Timepoint [4]
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Up to approximately 5.5 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is the time from first dose of belzutifan until death from any cause.
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Timepoint [5]
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Up to approximately 5.5 years
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Secondary outcome [6]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to approximately 5.5 years
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Secondary outcome [7]
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Number of Participants Discontinuing Study Drug due to an AE
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Assessment method [7]
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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.
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Timepoint [7]
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Up to approximately 5.5 years
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Secondary outcome [8]
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Time to Surgery (TTS)
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Assessment method [8]
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TTS is defined as the time from the first dose of belzutifan to the first documented surgical intervention or tumor reduction procedure.
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Timepoint [8]
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Up to approximately 5.5 years
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Eligibility
Key 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, 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.
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.
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-2a related genetic
alterations:
- Local test report documenting germline or somatic mutations in at least one of the
HIF-2a 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:
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.
- Has a life expectancy of at least 3 months.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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-2a 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.
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/02/2027
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Actual
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Sample size
Target
322
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Prince of Wales Hospital-Medical Oncology ( Site 1601) - Randwick
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Recruitment hospital [2]
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The Royal Melbourne Hospital ( Site 1602) - Parkville
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Iowa
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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0
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Pennsylvania
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Tennessee
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Texas
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Canada
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Alberta
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Canada
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Ontario
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China
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Beijing
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China
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Guangdong
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China
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Shanghai
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China
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Sichuan
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Denmark
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Hovedstaden
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Syddanmark
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France
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Alsace
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France
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Bouches-du-Rhone
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France
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Ile-de-France
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France
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Paris
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France
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Rhone-Alpes
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Berlin
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Hungary
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Budapest
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0
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Lombardia
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0
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Italy
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Brescia
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Italy
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Milano
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0
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Italy
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0
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Verona
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0
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Japan
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Hokkaido
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0
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Japan
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Kanagawa
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Japan
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Kochi
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0
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Japan
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Tokyo
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0
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Japan
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Kyoto
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Netherlands
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Utrecht
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Russian Federation
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Baskortostan, Respublika
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Russian Federation
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Leningradskaya Oblast
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0
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Russian Federation
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Moskva
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Singapore
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Central Singapore
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Spain
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Asturias
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Spain
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Madrid, Comunidad De
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Spain
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Barcelona
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Country [48]
0
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Sweden
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State/province [48]
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Skane Lan
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Country [49]
0
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Sweden
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State/province [49]
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Stockholms Lan
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Country [50]
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Sweden
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Uppsala Lan
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Country [51]
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Sweden
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Vastra Gotalands Lan
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Turkey
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Izmir
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Turkey
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Ankara
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Country [54]
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Turkey
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Istanbul
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United Kingdom
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Cambridgeshire
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United Kingdom
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England
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Country [57]
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United Kingdom
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Glasgow City
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Country [58]
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United Kingdom
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State/province [58]
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London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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-2a) 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04924075
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Toll Free Number
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Address
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0
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0
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Phone
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1-888-577-8839
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04924075
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