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HIF-2 Alpha Inhibitor
Belzutifan + Palbociclib for Kidney Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4.5 years
Awards & highlights
Study Summary
This trialassesses the safety & efficacy of belzutifan + palbociclib therapy for advanced ccRCC patients who have not responded to prior treatment.
Who is the study for?
This trial is for adults with advanced kidney cancer who've seen their disease get worse after at least two treatments, including anti-PD-1/L1 and VEGF-TKI therapies. They should have measurable disease, be recovered from past treatment side effects, and not need oxygen therapy or have had major surgery within the last 3 weeks.Check my eligibility
What is being tested?
The study tests belzutifan alone and combined with palbociclib in patients with advanced clear-cell renal cell carcinoma. It has two parts: first to find a safe dose of palbociclib for combination use, then to test the effectiveness and safety of this combo compared to just belzutifan.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, liver issues, blood count changes that can lead to infections or bleeding problems. There may also be risks related to heart health or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is at stage IV and cannot be surgically removed.
Select...
My kidney cancer has worsened after 2 treatments including PD-1/L1 and VEGF-TKI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE
Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE)
Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
+1 moreSecondary outcome measures
Part 2 - Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Part 2 - Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Part 2 - Number of Participants Who Discontinue Study Treatment Due to an AE
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 2 - Beltuzifan 120 mg + PalbociclibExperimental Treatment2 Interventions
Participants receive beltuzifan 120 mg orally QD and palbociclib orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation. Palbociclib will be administered at a dosage level determined in Part 1.
Group II: Part 2 - Beltuzifan 120 mgExperimental Treatment1 Intervention
Participants receive beltuzifan 120 mg orally QD until progressive disease or discontinuation.
Group III: Part 1 - Beltuzifan 120 mg + Palbociclib 75 mgExperimental Treatment2 Interventions
Participants receive beltuzifan 120 mg orally once per day (QD) and palbociclib 75 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Group IV: Part 1 - Beltuzifan 120 mg + Palbociclib 125 mgExperimental Treatment2 Interventions
Participants receive beltuzifan 120 mg orally QD and palbociclib 125 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Group V: Part 1 - Beltuzifan 120 mg + Palbociclib 100 mgExperimental Treatment2 Interventions
Participants receive beltuzifan 120 mg orally QD and palbociclib 100 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,491 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,564 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had hepatitis B or currently have hepatitis C.My liver is not working well.My cancer has spread to my brain or its coverings.I have another cancer that is getting worse or was treated in the last 3 years.I have a serious heart condition.I have not had major surgery in the last 3 weeks.My kidney cancer is at stage IV and cannot be surgically removed.I have been treated with belzutifan or palbociclib before.I have not received any colony-stimulating factors in the last 28 days.You have been diagnosed with HIV.My kidney cancer has worsened after 2 treatments including PD-1/L1 and VEGF-TKI.I have recovered from side effects of my previous treatments.Your disease can be measured by the study's assessment method.I need extra oxygen sometimes or all the time.I had radiotherapy less than 2 weeks ago and have recovered from side effects without needing steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 - Beltuzifan 120 mg
- Group 2: Part 1 - Beltuzifan 120 mg + Palbociclib 75 mg
- Group 3: Part 1 - Beltuzifan 120 mg + Palbociclib 100 mg
- Group 4: Part 1 - Beltuzifan 120 mg + Palbociclib 125 mg
- Group 5: Part 2 - Beltuzifan 120 mg + Palbociclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest possible number of participants in this experiment?
"Affirmative. Evidenced on clinicaltrials.gov, this medical study is currently recruiting participants; it was posted on August 10th 2022 and has been recently updated as of November 23rd 2022. The trial aims to enrol 180 individuals at a single site."
Answered by AI
Are there any availabilities for individuals to join the experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this medical experiment was first announced on August 10th 2022 and has been actively recruiting since then. The trial is looking for 180 patients at one single research centre."
Answered by AI
What are the foremost aims of this research endeavor?
"Within a period of up to 28 days, this clinical trial will measure the Objective Response Rate (ORR) per RECIST 1.1 as evaluated by investigators. Secondary objectives include recording the number of participants who experience any Adverse Events, Clinical Benefit Rates per RECIST 1.1 and those who had to discontinue treatment due to an AE."
Answered by AI
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