Pembrolizumab + Lenvatinib for Neuroendocrine Prostate Cancer
(PLANE-PC Trial)
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anti-androgen medications, before starting the study. However, LHRH agonists and GNRH antagonists can be continued. It's best to discuss your specific medications with the trial team to see if any need to be stopped.
Is the combination of pembrolizumab and lenvatinib generally safe for humans?
What makes the drug combination of Pembrolizumab and Lenvatinib unique for treating neuroendocrine prostate cancer?
The combination of Pembrolizumab and Lenvatinib is unique for treating neuroendocrine prostate cancer because it combines an immune checkpoint inhibitor (Pembrolizumab) with a targeted therapy (Lenvatinib) that may help overcome the limited efficacy of immunotherapy alone in this aggressive cancer type, offering a novel approach to a condition with few effective treatments.678910
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenvatinib and pembrolizumab in 21-day cycles, continuing until progression, toxicity, or decision to discontinue, with a maximum of 35 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lenvatinib
- Pembrolizumab
Lenvatinib is already approved in United States, European Union for the following indications:
- Differentiated Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Renal Cell Carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Ulka Vaishampayan
Lead Sponsor
Hoosier Cancer Research Network
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
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
University of Michigan
Collaborator