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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
The subject has histologically proven prostate cancer with radiologic evidence of metastases and at least one of the following: Small-cell or NEPC morphology (determined by the enrolling center) on the basis of tissue sample. Prostate adenocarcinoma with greater than 50% IHC staining for neuroendocrine markers (e.g., chromogranin and synaptophysin). Presence of visceral metastases or high volume disease (> 4 sites of metastases) with a PSA of ≤ 5. Serum chromogranin A level ≥ 5× upper limit of normal (ULN) and/or serum neuron specific enolase (NSE) ≥ 2× ULN. RBI deletions or mutations noted on genomic testing. Trans-differentiated carcinoma or poorly-differentiated carcinoma.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Neuroendocrine Tumors
  • Prostate Cancer

PLANE-PC Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

PLANE-PC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PLANE-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
~2700
Pembrolizumab
2017
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
288 Previous Clinical Trials
24,058 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

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04848337 — Phase 2
Neuroendocrine Tumors Research Study Groups: Study Treatment Arm
Neuroendocrine Tumors Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04848337 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04848337 — Phase 2

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
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer
Ulka Vaishampayan 2021. "Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04848337.
All > Prostate Cancer Anaheim > Neuroendocrine Tumor
~0 spots leftby Dec 2023
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