Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSheba Medical Center

About this trial

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

Eligibility criteria

Qualifiers

Female participants who are at least 18 years of age on the day of signing informed consent, with histologically-confirmed diagnosis of EOC (except from low grade tumors and mucinous histology).

Not a woman of childbearing potential (WOCBP) OR

A WOCBP who agrees to follow the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment.

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

Disqualifiers

A WOCBP who has a positive urine pregnancy test

The participant is pregnant or breastfeeding at Screening or Baseline, or is expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

The participant has received prior therapy with an anti-PD-1, anti-PD-L1 oranti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) in the last 6 months (6 months are calculated from the last dose until study initiation).

The participant has received prior systemic anti-cancer therapy mAb, chemotherapy or targeted small molecule therapy within 4 weeks prior to the planned first dose of the study, including investigational agents within 4 weeks. For tyrosine kinase inhibitors (TKIs), other than lenvatinib, and hormonal therapy a shorter interval of 5 half-lives is allowed between prior therapy and study treatment initiation.

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Lenvatinib

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators