IL-2 + Pembrolizumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jad Cuahoud, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab. Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™. Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.

Research Team

Jad Cuahoud, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Adults over 18 with metastatic kidney cancer, specifically clear cell renal carcinoma, who can provide consent and have measurable disease. They must be in good physical condition (ECOG 0 or 1), have proper organ function, agree to use contraception, and not be pregnant. Excluded are those with certain heart conditions, active infections requiring systemic therapy, known psychiatric or substance abuse disorders that could affect participation, recent use of investigational drugs or therapies including anti-PD-1/L1/L2 agents or monoclonal antibodies.

Inclusion Criteria

I agree to use birth control during and for 4 months after the study.

You have a solid tumor that can be measured using specific criteria.

I am willing to provide a tissue sample for the study.

Exclusion Criteria

I haven't had a heart attack, stroke, or major heart surgery in the last year.

I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.

I have a history of or currently have non-infectious lung inflammation.

Treatment Details

Interventions

• Interleukin-2 (Cytokine)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The trial is testing the combination of Interleukin-2 (Proleukin™) and Pembrolizumab (Keytruda™) for treating metastatic kidney cancer. The study aims to evaluate the effects when these two treatments are used together.

Participant Groups

Group I: Pembrolizumab and Interleukin-2 Experimental Treatment 2 Interventions

Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

H. Lee Moffitt Cancer Center and Research Institute Tampa, FL

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Patrick Hwu

H. Lee Moffitt Cancer Center and Research Institute

Chief Executive Officer since 2020

MD from The Medical College of Pennsylvania

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

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

Prometheus Laboratories

Industry Sponsor

Trials

27

Recruited

4,800+