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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Neuroendocrine Prostate Cancer (PLANE-PC Trial)
Phase 2
Recruiting
Led By Ulka Vaishampayan, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has adequate organ function as defined in the table below; all screening labs to be obtained within 10 days prior to Cycle 1 Day 1. Absolute neutrophil count (ANC) ≥ 1500/mm3without colony stimulating factor support Platelets ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL. Transfusions are allowed as needed. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 30 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used. Bilirubin ≤ 1.5 x the upper limit of normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement, or ≤ 5 and/or ULN with liver involvement International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants Urine protein < 2+ by urine dipstick A male participant must agree to use of contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. Projected life expectancy of at least 6 months as determined by treating physician. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Age ≥ 18 years at the time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
PLANE-PC Trial Summary
This trial will use a combination of lenvatinib and pembrolizumab to treat eligible patients. Each cycle is 21 days long, and the therapy will continue until the patient's condition either improves or worsens, they can't tolerate the treatment, or they and their physician decides to stop. Up to 35 cycles may be administered.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include high blood pressure; fatigue; liver enzyme changes; protein in urine; risk of bleeding or clotting disorders; possible allergic reactions to the drugs' components; autoimmune responses that could affect lung tissue.
PLANE-PC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is a type that is hard to identify or has changed its characteristics.
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My kidney function, measured by creatinine levels, is within the normal range.
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My cancer has been identified as small-cell or neuroendocrine prostate cancer.
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My prostate cancer shows high levels of certain markers.
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My cancer has spread to vital organs or I have more than 4 cancer sites with a low PSA.
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I have prostate cancer with spread and specific test results or conditions.
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My genetic test shows RBI deletions or mutations.
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My liver enzymes are within the required range.
PLANE-PC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiologic Progression Free Survival (rPFS) for bone lesions
Radiologic Progression Free Survival (rPFS) for soft tissue lesions
Secondary outcome measures
Duration of Response (DoR)
Frequency and Severity of adverse events
Objective Response Rate (ORR)
+1 morePLANE-PC Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Treatment ArmExperimental Treatment2 Interventions
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,211 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
96 Patients Enrolled for Neuroendocrine Tumors
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,705 Total Patients Enrolled
Ulka VaishampayanLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I haven't had cancer treatment or major surgery in the last 3 weeks and have recovered from side effects.I am 18 years old or older.I have or had severe lung inflammation that needed steroids.I do not have an active, uncontrolled infection.My urine protein levels are low based on tests.I haven't used any experimental drugs or devices in the last 3 weeks.My brain metastases are stable, and I haven't needed steroids for 14 days.I do not have serious heart problems like recent heart attacks or severe heart failure.My cancer is a type that is hard to identify or has changed its characteristics.I have not received a live vaccine within the last 30 days, except for COVID-19 vaccines.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have prostate cancer with spread and specific test results or conditions.My kidney function, measured by creatinine levels, is within the normal range.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have no other cancers that needed treatment in the last 3 years, except for certain skin cancers or localized cancers that were treated.I have a known history of HIV.I don't have bleeding disorders or a high risk of severe bleeding.I have a history of Hepatitis B or active Hepatitis C.My cancer has been identified as small-cell or neuroendocrine prostate cancer.My prostate cancer shows high levels of certain markers.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I am currently on anti-androgen medication but can stop oral forms if required.I have been treated with specific cancer drugs targeting my immune system.My cancer has spread to vital organs or I have more than 4 cancer sites with a low PSA.My blood pressure is high despite taking medication.I have prostate cancer that has spread, confirmed by tests.I am fully active or restricted in physically strenuous activity but can do light work.I've had over two chemotherapy treatments for advanced prostate cancer and stopped any hormone-targeting drugs at least 2 weeks ago.My hemoglobin level is at least 9 g/dL, transfusions included.I have an active tuberculosis infection.My genetic test shows RBI deletions or mutations.I have wounds from surgery that haven't healed.My liver enzymes are within the required range.I had radiotherapy over 2 weeks ago, with no ongoing side effects and haven't needed steroids.I understand and can follow the study's procedures.My organ functions are within the required range for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other research initiatives have been undertaken using Lenvatinib?
"Presently, 1032 clinical trials worldwide are studying the effects of Lenvatinib. Of those active studies, 134 of them are in their final Phase 3 stage. Primarily based in Sacramento, California; 37061 locations have opened up testing sites for this particular medication."
Answered by AI
What is the intended outcome of this trial?
"This two-year trial seeks to assess the Radiologic Progression Free Survival (rPFS) of soft tissue lesions. Secondary measurements such as Overall Survival, Objective Response Rate and Frequency/Severity of Adverse Events will be taken in accordance with Common Terminology Criteria for Adverse Events version 5.0."
Answered by AI
To what extent is this research currently enrolling participants?
"The sponsor, Merck Sharp & Dohme LLC, must recruit 50 patients that meet the pre-defined inclusion criteria in order to initiate this trial. The clinical sites include University of Michigan Health System located in Ann Arbor and Winship Cancer Instituted from Emory University based out of Atlanta."
Answered by AI
Are applications for this experiment being accepted currently?
"According to the information provided by clinicaltrials.gov, this investigation is actively searching for research subjects. The trial was first made available on May 25th 2021 and has been recently revised on October 26th 2022."
Answered by AI
What kind of adverse reactions have been observed in people taking Lenvatinib?
"Lenvatinib's safety has been characterized to some extent, thus a score of 2 was assigned. This is because there are Phase 2 clinical trial results for this medication but no established evidence supporting its efficacy."
Answered by AI
What medical goals is Lenvatinib typically utilized to achieve?
"Lenvatinib is typically employed to battle malignant tumours. It can also be used to help individuals with unresectable melanoma, microsatellite instability high and those that have regressed after chemotherapy therapy."
Answered by AI
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