Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05468697




Registration number
NCT05468697
Ethics application status
Date submitted
18/07/2022
Date registered
21/07/2022
Date last updated
2/02/2024

Titles & IDs
Public title
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
Scientific title
A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma
Secondary ID [1] 0 0
MK-6482-024
Secondary ID [2] 0 0
6482-024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belzutifan
Treatment: Drugs - Palbociclib

Experimental: Part 1 - Beltuzifan 120 mg + Palbociclib 75 mg - 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.

Experimental: Part 1 - Beltuzifan 120 mg + Palbociclib 100 mg - 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.

Experimental: Part 1 - Beltuzifan 120 mg + Palbociclib 125 mg - 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.

Experimental: Part 2 - Beltuzifan 120 mg + Palbociclib - 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.

Experimental: Part 2 - Beltuzifan 120 mg - Participants receive beltuzifan 120 mg orally QD until progressive disease or discontinuation.


Treatment: Drugs: Belzutifan
40 mg tablet administered orally at a dose of 120 mg.

Treatment: Drugs: Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to approximately 28 days
Primary outcome [2] 0 0
Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 4.5 years
Primary outcome [3] 0 0
Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [3] 0 0
Up to approximately 4.5 years
Primary outcome [4] 0 0
Part 2 - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [4] 0 0
Up to approximately 4.5 years
Secondary outcome [1] 0 0
Part 2 - Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [1] 0 0
Up to approximately 4.5 years
Secondary outcome [2] 0 0
Part 2 - Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [2] 0 0
Up to approximately 4.5 years
Secondary outcome [3] 0 0
Part 2 - Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Timepoint [3] 0 0
Up to approximately 4.5 years
Secondary outcome [4] 0 0
Part 2 - Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 4.5 years
Secondary outcome [5] 0 0
Part 2 - Number of Participants Who Experience at Least One Adverse Event (AE)
Timepoint [5] 0 0
Up to approximately 4.5 years
Secondary outcome [6] 0 0
Part 2 - Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [6] 0 0
Up to approximately 4.5 years

Eligibility
Key inclusion criteria
- 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

- Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by
blinded independent central review (BICR)

- Has recovered from all AEs due to previous therapies
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has hypoxia, requires intermittent supplemental oxygen, or requires chronic
supplemental oxygen

- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years

- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has clinically significant cardiac disease

- Has moderate to severe hepatic impairment

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection

- Has received prior treatment of belzutifan or palbociclib

- Has received prior radiotherapy =2 weeks prior to first dose of study intervention.
Participants must have recovered from all radiation-related toxicities and not require
corticosteroids

- Has had major surgery =3 weeks prior to first dose of study intervention

- Has received colony-stimulating factors (eg, 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/03/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) - Macquarie University
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Utah
Country [4] 0 0
Israel
State/province [4] 0 0
Haifa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy
and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell
renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior
therapy. Part 1 will establish the safety of belzutifan plus palbociclib and determine a
recommended dosage of palbociclib for the combination therapy by ascending dose escalation.
Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage
level determined in Part 1.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05468697
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05468697