UnknownPhase 2

Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)

Singapore10 participantsStarted 2021-02-18

Plain-language summary

This is a phase II non-randomized, multi-center study. The primary end point of this study is the objective response rate (ORR) at 24 weeks, using response evaluation criteria for solid tumors (RECIST) 1.1 criteria, for the combination therapy of continuous daily oral lenvatinib with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma of gynecological origin (CCGC). The statistical design is Simon's minimax two-stage design and the present study aims to complete stage 1 of the Simon's two-stage design.

Who can participate

Age range21 Years – 99 Years

SexALL

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Inclusion criteria

✓. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
✓. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.

What they're measuring

objective response rate (ORR)

Timeframe: 4 years

Progression-free survival

Timeframe: 4 years

Duration of response

Timeframe: 4 years

Trial details

NCT IDNCT04699071

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

David Shao Peng Tan

6772 4661 David_SP_Tan@nuhs.edu.sg

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