NCT04848337

Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer Metastatic
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
DRUG	Lenvatinib	Lenvatinib 20 mg orally daily.

Timeline

• Start date: 2021-05-25
• Primary completion: 2025-01-08
• Completion: 2026-04-01
• First posted: 2021-04-19
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study