Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT03290079|
Recruitment Status : Suspended (Investigator working on amendment.)
First Posted : September 21, 2017
Last Update Posted : May 22, 2020
The purpose of this study is to:
- Assess overall radiographic response rate (ORR)
- Assess progression-free survival (PFS)
- Test the safety and tolerability of Pembrolizumab
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neuroendocrine Carcinoma Neuroendocrine Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Simon 2-stage design|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors|
|Actual Study Start Date :||November 17, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Pembrolizumab Treatment
Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks. Estimated average length of treatment per participant: 4 months.
Second Course Study Treatment: Participants may be eligible for up to one year of additional pembrolizumab therapy if they progress after stopping study treatment. If they meet the criteria to be eligible for the Second Course, participants will restart treatment at the same dose and dose interval as when they last received pembrolizumab.
Pembrolizumab Day 1 of each 3 week cycle.
Other Name: Keytruda®
- Objective Radiographic Response Rate (ORR) [ Time Frame: Up to 12 months ]Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
- Duration of Response (DOR) [ Time Frame: Up to 12 months ]DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.
- Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 12 months ]OS defined as the time from initial treatment until death from any cause.
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): NCT03290079
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|