A Phase 2 interventional study of Belzutifan and Cabozantinib in Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC) and Kidney Cancer, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Active, not recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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Among 18 studies testing belzutifan in Carcinoma, Renal Cell — 5 open to participants now, 13 under way, 5 of them phase 3. belzutifan · Carcinoma, Renal Cell.
Among the 18 studies testing belzutifan in Carcinoma, Renal Cell, this one is the 11th largest by planned enrollment, is the only one that started in 2018, is one of 7 in phase 2, reaches primary completion later than 7 of the 12 other live ones, and was the 2nd registered.
2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →5 of the 18 studies testing belzutifan in Carcinoma, Renal Cell are open now, in 4 countries. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
José Claudio Casali da Rocha · Sites in Brazil
Ages 14+
Vall d'Hebron Institute of Oncology · Sites in Spain
Ages 18+
Peter MacCallum Cancer Centre, Australia · Sites in Australia
Ages 18+
By country, each count listing its studies:
belzutifan: first FDA approval 2021 (WELIREG), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →
Of the 307 Carcinoma, Renal Cell studies recruiting now, 254 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, belzutifan is the treatment under test here. Read study by study →
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 9 · Phase 3 5
First in 2016; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 118 is above the median of 43 across 1,565 interventional studies indexed under Carcinoma, Renal Cell.
Median enrollment 135 across the 18 interventional studies. Of the 5 that completed or were terminated, 2 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 18 have an industry lead sponsor. The 7 most frequent:
This study is registered under Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), one of the names counted as Merck & Co., Inc. Under that name alone:
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 7 studies on the registry; none are open to participants now.
33 studies in Carcinoma, Renal Cell by Merck & Co., Inc: 3 open now, 15 under way, 7 of them phase 3. Of 18 finished, 12 (67%) have results posted.
Among the 33 studies in Carcinoma, Renal Cell by Merck & Co., Inc, this one is the 21st largest by planned enrollment, is the only one that started in 2018, is one of 9 in phase 2, reaches primary completion later than 9 of the 14 other live ones, and was the 15th registered.
Merck & Co., Inc’s Carcinoma, Renal Cell studies by the year they started, since 2007.
3 of the studies testing belzutifan in Carcinoma, Renal Cell that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03634540Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) | 2027-02-26 |
| NCT05030506Merck Sharp & Dohme LLCA Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010) | 2027-06-30 |
| NCT07187778M.D. Anderson Cancer CenterPhase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE) | 2027-07-19 |
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Among the 18 studies testing belzutifan in Carcinoma, Renal Cell, from their registry updates:
Among Merck & Co., Inc’s 33 in Carcinoma, Renal Cell:
This tab as a report to print or save as PDF → With an account.
This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has adequate organ function defined as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.
Drug: Belzutifan · Drug: Cabozantinib
Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.
Drug: Belzutifan · Drug: Cabozantinib
Belzutifan tablets administered orally.
Also known as: PT2977, MK-6482, WELIREG™
Cabozantinib tablets administered orally.
Also known as: CABOMETYX®
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a best confirmed response of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
PFS is defined as the interval from the start of study treatment until the earlier of the first documentation of disease progression determined by RECIST 1.1 or death from any cause.
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of response, as determined by RECIST 1.1, to the earlier of the first documentation of disease progression or death from any cause, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions).
Time frame: Up to approximately 2 years
Time to Response (TTR)
TTR is defined as the interval from the start of study treatment to the first documentation of a response, as determined by RECIST 1.1, and calculated for participants with a best confirmed response of CR or PR.
Time frame: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the interval from the start of treatment to the death of the participant from any cause.
Time frame: Up to approximately 2 years
Number of participants experiencing an Adverse Event (AE)
An AE is 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, symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. Included in this definition are any newly occurring events and any previous condition that has increased in severity or frequency since the administration of study drug.
Time frame: Up to approximately 2 years
Number of participants discontinuing study treatment due to an Adverse Event (AE)
An AE is 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, symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. Included in this definition are any newly occurring events and any previous condition that has increased in severity or frequency since the administration of study drug.
Time frame: Up to approximately 2 years
Belzutifan Plasma Concentration
Blood samples for the determination of belzutifan concentration will be collected at pre-specified timepoints before and after treatment administration.
Time frame: Weeks 1 and 4: pre-dose, 2 and 6 hours post-dose
Belzutifan Metabolite Plasma Concentration
Blood samples for the determination of belzutifan metabolite concentration will be collected at pre-specified timepoints before and after treatment administration.
Time frame: Weeks 1 and 4: pre-dose, 2 and 6 hours post-dose
Cabozantinib Plasma Concentration
Blood samples for the determination of cabozantinib concentration will be collected at pre-specified timepoints before and after treatment administration.
Time frame: Weeks 1 and 4: pre-dose, 2 and 6 hours post-dose
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Started Sep 2018 (actual). Primary completion is estimated for Feb 2027, 100 months after the start.
Of 47 industry-sponsored phase 2 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's planned 100 months is above that.
Counting every sponsor, half of 230 studies reached it within 58 months; a quarter within 33 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Belzutifan
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) →