Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04848337
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 25, 2021
Status verified
Apr 2026
Primary completion
Jan 8, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment Arm
    Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days

Primary Outcome Measure

Radiologic Progression Free Survival (rPFS) [ Time Frame: 6 months, with a 1-week window ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Winship Cancer Instituted of Emory UniversityAtlantaGeorgia30322-
University of Michigan Health SystemAnn ArborMichigan48109-
Oregon healthPortlandOregon97239-
Froedtert and The Medical College of WisconsinMilwaukeeWisconsin53226-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
City of Hope· Duarte, CAWinship Cancer Instituted of Emory University· Atlanta, GAUniversity of Michigan Health System· Ann Arbor, MIOregon health· Portland, ORFroedtert and The Medical College of Wisconsin· Milwaukee, WI

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