Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)
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|ClinicalTrials.gov Identifier: NCT04699071|
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : October 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinomas Recurrent Gynecological||Drug: pembrolizumab and lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||combination therapy of continuous daily oral lenvatinib with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma of gynecological origin (CCGC).|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)|
|Actual Study Start Date :||February 18, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2025|
Experimental: patients with recurrent clear cell carcinoma of gynecological origin (CCGC)
Recurrent clear cell carcinoma of gynecological origin (ovarian and endometrial primary) after progression on chemotherapy.
Drug: pembrolizumab and lenvatinib
All patients will receive oral lenvatinib daily plus intravenous pembrolizumab 3-weekly.
A cycle is 21 days. Allowances will be made for stepwise dose reductions of lenvatinib due to treatment-related toxicities.
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, (CTCAE) Version 5.0.
Patients are planned to continue therapy until disease progression, intolerable toxicity, or withdrawal of patient consent.
- objective response rate (ORR) [ Time Frame: 4 years ]the percentage of subjects with a confirmed CR or PR as per RECIST 1.1 criteria.
- Progression-free survival [ Time Frame: 4 years ]time from enrolment to the first documented tumor progression, or death due to any cause whichever occurred first. PFS time of any living patient with no documented progression, or any patient starting other cytotoxic and/or cytostatic therapies, will be censored at the date of last evaluable disease assessment on-study. PFS time of patients with no evaluable disease assessment on-study will be censored at enrollment
- Duration of response [ Time Frame: 4 years ]This will be measured from the time measurement criteria for CR/PR (whichever is first recorded) are first met until the first date that recurrent or progressive disease is objectively documented.
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): NCT04699071
|Contact: David Shao Peng Tan||6772 4661||David_SP_Tan@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Contact: David Shao Peng Tan 6772 4661 David_SP_Tan@nuhs.edu.sg|
|Principal Investigator:||David Shao Peng Tan||National University Hospital, Singapore|