Lenvatinib + Pembrolizumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Joel Picus, MD - Washington University ...

Overseen byJoel Picus

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a single-arm, multicenter, phase 2 study of lenvatinib in combination with pembrolizumab (lenvatinib 20 mg/day + pembrolizumab 200mg q3weeks) in subjects with unresectable advanced or metastatic non-clear cell renal carcinoma who have not received any chemotherapy for advanced disease.

Research Team

Joel Picus

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Adults with advanced or metastatic non-clear cell renal carcinoma who haven't had chemotherapy for advanced disease. They must have specific subtypes of kidney cancer, normal blood pressure, adequate organ function, and no major surgery within the last month. Women must not be pregnant and agree to contraception; men also need to follow certain contraceptive guidelines.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document

I am using birth control as a man with a partner who can have children.

I can provide a recent tumor sample for testing.

See 13 more

Exclusion Criteria

I have or had lung inflammation needing steroids, not caused by an infection.

I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.

I have had an organ or stem cell transplant from a donor.

See 18 more

Treatment Details

Interventions

Lenvatinib (Tyrosine Kinase Inhibitor)
Pembrolizumab (Checkpoint Inhibitor)
Research blood collection (Procedure)

Trial OverviewThe trial is testing a combination of two drugs: Lenvatinib (20 mg/day) and Pembrolizumab (200mg every three weeks), along with research blood collection in patients with certain types of kidney cancer that has spread and cannot be surgically removed.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Lenvatinib + PembrolizumabExperimental Treatment3 Interventions

* Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.