Belzutifan for Carcinoma, Renal Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Renal Cell+1 More
Belzutifan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of two doses of belzutifan in people with advanced kidney cancer that has spread after previous treatment. The higher dose is expected to be better in terms of tumor shrinkage.

Eligible Conditions
  • Carcinoma, Renal Cell

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Renal Cell

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to approximately 48 months

Month 48
Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AEs)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Week 5
Maximum Plasma Concentration (Cmax) of belzutifan
Trough Plasma Concentration (Ctrough) of belzutifan

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma, Renal Cell

Trial Design

2 Treatment Groups

Dose B (higher dose)
1 of 2
Dose A (standard dose)
1 of 2
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Belzutifan · No Placebo Group · Phase 2

Dose B (higher dose)
Drug
Experimental Group · 1 Intervention: Belzutifan · Intervention Types: Drug
Dose A (standard dose)
Drug
Experimental Group · 1 Intervention: Belzutifan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 48 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,953,457 Total Patients Enrolled
47 Trials studying Carcinoma, Renal Cell
14,968 Patients Enrolled for Carcinoma, Renal Cell
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,579,054 Total Patients Enrolled
14 Trials studying Carcinoma, Renal Cell
6,588 Patients Enrolled for Carcinoma, Renal Cell
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,936,675 Total Patients Enrolled
24 Trials studying Carcinoma, Renal Cell
8,946 Patients Enrolled for Carcinoma, Renal Cell

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The person has a cancer that has been confirmed by a tissue sample to be locally advanced or metastatic (spread to other parts of the body) and is composed of clear cells.
therapy The patient has recovered from all adverse events (AEs) due to previous therapies, with the exception of neuropathy or endocrine-related AEs that are grade 2 or lower and require treatment or hormone replacement therapy.
The subject has a Karnofsky performance status score of at least 70% assessed within 10 days prior to the first dose of study intervention.
A man is eligible to participate in the study if he does not have sex with women or agrees to use a condom and birth control for the duration of the study and for seven days after the last dose of the study intervention.
; using a highly effective contraceptive method (defined as a condom plus one other highly effective contraceptive method from the following: tubal ligation, partner’s vasectomy, implant, injectable, IUD, or oral contraceptive pill) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential or a woman of childbearing potential who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention; using a highly effective contraceptive method (defined as a condom plus one other highly effective contraceptive method from the following: tubal ligation, partner’s vasectomy, implant, injectable, IUD, or oral contraceptive pill).
BICR found that the disease has measurable signs according to RECIST 1.
You can submit a tumor tissue sample that has been archived or a newly obtained tumor lesion biopsy.
This person has received no more than 3 prior systemic treatments for locally advanced or metastatic renal cell carcinoma.
The individual has only received one prior treatment with a drug that targets the PD-1 protein and the L1 protein
You have a disease progression on or after treatment with an anti-PD-1/L1 therapy for locally advanced or metastatic renal cell carcinoma.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.