Avelumab, Palbociclib and Axitinib in Advanced RCC (APART)
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|ClinicalTrials.gov Identifier: NCT05176288|
Recruitment Status : Not yet recruiting
First Posted : January 4, 2022
Last Update Posted : June 28, 2022
The aim of this study is to see whether the combination of 3 drugs (axitinib, avelumab and palbociclib) is safe and effective in slowing down the growth of advanced clear cell renal cell carcinoma (ccRCC) in patients that have not received any prior systemic treatment.
The names of the study drug involved in this study are/is:
|Condition or disease||Intervention/treatment||Phase|
|Advanced Clear Cell Renal Cell Carcinoma||Drug: Axitinib Drug: Palbociclib Drug: Avelumab||Phase 2|
This is a multi-center, single-arm, phase 2 study to evaluate the efficacy of the combination of axitinib, avelumab, and palbociclib in patients with untreated, advanced clear cell renal cell carcinoma (ccRCC).
This research study involves an investigational drug combination (axitinib, avelumab and palbociclib) not approved by the FDA (USA Food and Drug Administration) for treatment of advanced clear cell renal cell carcinoma (ccRCC), though the combination of axitinib and avelumab has been approved for use in advanced clear cell renal cell carcinoma (ccRCC) treatment. Palbociclib is a CDK inhibitor, which targets growing cancer cells by blocking how a phosphate molecule is added to an important regulatory protein called retinoblastoma so preventing the formation of new cancer cells.
Study procedures include screening for eligibility, study treatment, participant evaluations and safety follow visits in addition to general health status follow-up after study treatment. Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse, and will be followed for as long as they remain on the study.
It is expected that about 25 people will take part in this research study.
Pfizer is supporting this research study by providing the study drugs (axitinib, avelumab and palbociclib).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Avelumab, Palbociclib and Axitinib in in Treatment Naive Metastatic Clear Cell Renal Cell Carcinoma.|
|Estimated Study Start Date :||July 2022|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
Experimental: Axitinib, Avelumab and Palbociclib
During each 28 day (+/- 3 days) study cycle, all participants will receive:
Other Name: Inlyta
Other Name: Ibrance
Other Name: Bavencio
- Best Overall Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, for duration of therapy assessed up to 100 months ]Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taken as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- Median Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Based on the Kaplan-Meier method, median progression-free survival (PFS) is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taken as reference of the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Disease progression (PD) for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
- Median Overall Survival (OS) [ Time Frame: Participants followed for long-term for survival every 6 months from the end of treatment until death or lost to follow-up, up to 2 years after treatment discontinuation. ]Based on the Kaplan-Meier method overall survival (OS) is defined as the time from study entry to death or censored at date last known alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05176288
|Contact: Bradley McGregor, MDemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Contact: David Einstein, MD 617-667-2100 Deinstei@bidmc.harvard.edu|
|Principal Investigator: David Einstein, MD|
|Principal Investigator:||Bradley McGregor, MD||Dana-Farber Cancer Institute|