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.
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.
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.
Single group
Pembrolizumab
Drug200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Lenvatinib
Drug20 mg administered orally (PO) QD during each 21-day cycle.
PFS of patients treated with pembrolizumab in combination with lenvatinib.
defined as the time from study treatment initiation to the first documented disease progression according to RECIST 1.1 or death from any cause.
Objective response rate (ORR) in patients treated with a combination of pembrolizumab and lenvatinib.
defined as the percentage of evaluable patients with complete response (CR) or partial response (PR). Response will be evaluated by the Investigator according to RECIST 1.1.
Time to subsequent therapy (in months)- time from enrollment to next line of therapy initiation
defined as the time (in months) from initiation of treatment with pembrolizumab and Lenvatinib to subsequent chemotherapy treatment initiation.
Overall survival (OS) of the study population.
defined as the time from study treatment initiation to death due to any cause.
Impact of the treatment protocol on health-related quality of life using the QOL questionnaire (EORTC) QLQ-C30
To evaluate the impact of the treatment protocol on health-related quality of life (HR-QoL) as assessed by using the global score of the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
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