NCT05176288

Avelumab, Palbociclib and Axitinib in Advanced RCC

Avelumab, Palbociclib and Axitinib in in Treatment Naive Metastatic Clear Cell Renal Cell Carcinoma.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bradley A. McGregor, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Axitinib * Avelumab * Palbociclib

Detailed description

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).

Conditions

• Advanced Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Axitinib	Taken Orally
DRUG	Palbociclib	Taken Orally
DRUG	Avelumab	Intravenous infusion

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2022-01-04
• Last updated: 2023-09-07

Regulatory

• FDA-regulated drug study