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Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Phase II Trial of Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

NCT04848337•University of Michigan Rogel Cancer Center

Summary

Eligible patients will be treated with the combination of lenvatinib and pembrolizumab. A cycle equals 21 days and therapy will continue until radiographic progression, intolerable toxicity, or patient/physician wishes to discontinue protocol therapy. A maximum of 35 cycles may be administered. On Day 1, when both pembrolizumab and lenvatinib are administered, patients should take the lenvatinib per their normal routine.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•2. Age ≥ 18 years at the time of consent.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the date of registration.
•4. 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.
+12 more criteria

Exclusion Criteria

•1. Received prior therapy with VEGF-TKI, immune checkpoint inhibitor, an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
•2. Received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to registration. NOTE: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. NOTE: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
•3. Received more than two prior chemotherapy regimens for metastatic prostate cancer. Prior therapy with androgen receptor axis targeted agents is allowed but needs to be discontinued at least 2 weeks prior to study therapy. Prior therapy with Rad-223 or other radiopharmaceuticals is permitted but study therapy should be started at least 4 weeks after the last dose.
•4. Concurrent treatment with anti-androgen medications. NOTE: LHRH agonists and GNRH antagonists may be continued. All oral anti androgens should be discontinued.
•5. Received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
•6. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to the first dose of study treatment. NOTE: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.
•7. Uncontrolled blood pressure (Systolic BP\>140 mmHg or diastolic BP \>90 mmHg) despite an optimized regimen of antihypertensive medication.
•8. Presence of non-healing wounds after surgical procedures.
•9. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•10. Received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed viruses are allowed. All COVID-19 vaccines are permitted at any time before or during the study.
+13 more criteria

Locations (5)

City of Hope

Duarte, California, United States

Winship Cancer Instituted of Emory University

Atlanta, Georgia, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Oregon health

Portland, Oregon, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

May 25, 2021

Primary Completion Date

January 8, 2025

Completion Date

April 1, 2026

Last Updated

February 12, 2026

Enrollment

ACTUAL participants

Conditions

Prostate Cancer MetastaticNeuroendocrine Tumors

Interventions

Pembrolizumab

DRUG

Lenvatinib

DRUG

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Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

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Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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