Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer (PLANE-PC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04848337|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic Neuroendocrine Tumors||Drug: Pembrolizumab Drug: Lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer|
|Actual Study Start Date :||May 25, 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||July 2023|
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
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Name: Keytruda
Lenvatinib 20 mg orally daily.
Other Name: Lenvima
- Radiologic Progression Free Survival (rPFS) for soft tissue lesions [ Time Frame: 2 years ]For soft tissue lesions, rPFS is defined as the date of treatment intiation to date of radiologic progression of soft tissue lesions per RECIST 1.1 or death whichever occurs first.
- Radiologic Progression Free Survival (rPFS) for bone lesions [ Time Frame: 2 years ]For bone lesions, rPFS is defined as the date of treatment initiation to date of progression of bone lesions per PCWG3 criteria or death whichever occurs first.
- Frequency and Severity of adverse events [ Time Frame: 2 years ]Frequency and severity of adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Overall Survival (OS) [ Time Frame: 2 years ]Overall survival (OS) will be measured from date of registration to date of death from any cause.
- Objective Response Rate (ORR) [ Time Frame: 2 years ]ORR will be the proportion of patients achieving either a complete response or a partial response
- Duration of Response (DoR) [ Time Frame: 2 years ]DOR will be measured from the start date of the best response achieved until the date of relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848337
|Contact: Ulka Vaishampayan, MDfirstname.lastname@example.org|
|Contact: LeaEtta Hyer||13176345842 ext email@example.com|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Charles Leister 734-232-2464 firstname.lastname@example.org|
|Principal Investigator: Ulka Vaishampayan, MD|
|Principal Investigator:||Ulka Vaishampayan, MD||University of Michigan|