Lenvatinib + Pembrolizumab for Kidney Cancer

Recruiting at 3 trial locations

Overseen By Joel Picus

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Biologic response modifiers

Disqualifiers: Clear cell RCC, Brain metastasis, Heart failure, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: Approximately 2 years

11 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenvatinib 20 mg/day orally and pembrolizumab 200 mg every 3 weeks for up to 35 cycles or approximately 2 years

Approximately 2 years

Pembrolizumab administered every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up lasting up to 120 days after the last day of study treatment

Approximately 4 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Median length 602 days

Treatment Details

Interventions

• Lenvatinib
• Pembrolizumab
• Research blood collection

Trial Overview The 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

Group I: Lenvatinib + Pembrolizumab Experimental Treatment 3 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.

Lenvatinib is already approved in United States, European Union for the following indications:

Approved in United States as Lenvima for:

• Differentiated Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Lenvima for:

• Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Kisplyx for:

• Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University