Avelumab, Palbociclib and Axitinib in Advanced RCC
(APART Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byBradley McGregor, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bradley A. McGregor

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Bradley McGregor, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

You are 18 years old or older.

You can swallow pills or tablets.

A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met: The biopsy or resection was performed within 1 year of registration AND The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable

See 12 more

Exclusion Criteria

Participants who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to at least grade 1.

Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.

Major surgery within the past 4 weeks or major radiation therapy within 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 48 hours prior to patient randomization.

See 26 more

Treatment Details

Interventions

Avelumab (Monoclonal Antibodies)
Axitinib (Tyrosine Kinase Inhibitor)
Palbociclib (CDK4/6 Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Axitinib, Avelumab and PalbociclibExperimental Treatment3 Interventions

During each 28 day (+/- 3 days) study cycle, all participants will receive: * Axitinib: 2x Daily until it is determined participant must stop the drug * Palbociclib: Taken 1x time per day on days 8-28 of each cycle until it is determined participant must stop the drug. * Avelumab: Once every 2 weeks continued for up to 2 years or earlier if it is determined participant must stop the study drug

Avelumab is already approved in Japan for the following indications: