Pembrolizumab + Lenvatinib for Neuroendocrine Prostate Cancer

(PLANE-PC Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Ulka Vaishampayan, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial uses a combination of two drugs, lenvatinib and pembrolizumab, to treat patients with cancer that hasn't responded to other treatments. Lenvatinib stops cancer cells from growing, while pembrolizumab helps the immune system attack the cancer. The combination received accelerated FDA approval in September 2019 for all patients with advanced endometrial cancer who have disease progression following previous treatments. The treatment cycles last a few weeks and can continue for several months unless there are side effects or other reasons to stop.

Research Team

Ulka Vaishampayan, MD

Principal Investigator

University of Michigan

Eligibility Criteria

Adults (18+) with advanced/metastatic prostate cancer showing neuroendocrine characteristics, not previously treated with certain therapies like VEGF-TKI or immune checkpoint inhibitors. Participants must have an ECOG performance status of 0 or 1, adequate organ function, and agree to use contraception. Exclusions include active CNS metastases, recent live vaccines, severe cardiovascular issues, uncontrolled infections, other active cancers within the past 3 years.

Inclusion Criteria

- Serum chromogranin A level ≥ 5× upper limit of normal (ULN) and/or serum neuron specific enolase (NSE) ≥ 2× ULN.

I agree to use contraception and not donate sperm for 120 days after my last treatment dose.

I am 18 years old or older.

Exclusion Criteria

I haven't had cancer treatment or major surgery in the last 3 weeks and have recovered from side effects.

I have or had severe lung inflammation that needed steroids.

I do not have an active, uncontrolled infection.

Treatment Details

Interventions

• Lenvatinib (Tyrosine Kinase Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview The trial tests a combination of Pembrolizumab and Lenvatinib for patients with specific types of prostate cancer. Treatment cycles last 21 days and may continue up to a maximum of 35 cycles unless there's disease progression or unacceptable side effects.

Participant Groups

Group I: Study Treatment Arm Experimental Treatment 2 Interventions

Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Winship Cancer Instituted of Emory University Atlanta, GA

Froedtert and The Medical College of Wisconsin Milwaukee, WI

University of Michigan Health System Ann Arbor, MI

Oregon health Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Patients Recruited

20,700+

Ulka Vaishampayan

Lead Sponsor

Trials

1

Patients Recruited

50+

Hoosier Cancer Research Network

Collaborator

Trials

69

Patients Recruited

3,800+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4096

Patients Recruited

5,232,000+

University of Michigan

Collaborator

Trials

1891

Patients Recruited

6,458,000+