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New treatment option for Ovarian Neoplasms
Official title Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT04519151
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ovarian neoplasms.
Also referred to as KEYTRUDA®, MK-3475.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female participants who are at least 18 years of age on the day of signing informed consent, with histologically-confirmed diagnosis of EOC (except...
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- 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.
You likely can't join if
- 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...
- 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...
- The participant has received prior systemic anti-cancer therapy mAb, chemotherapy or targeted small molecule therapy within 4 weeks prior to the...
- The participant has received prior lenvatinib.
- The participant has received prior radiotherapy within 2 weeks of start of study treatment.
See the full eligibility criteria
Who can join
- 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).
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- 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.
- Have measurable disease at baseline based on RECIST 1.1. Lesions
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have received a front-line platinum-based regimen per local standard of care or treatment guideline following the primary or interval debunking surgery with radiologically documented disease recurrence no earlier than 6...
What rules you out
- 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...
- 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...
- 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...
- The participant has received prior lenvatinib.
- The participant has received prior radiotherapy within 2 weeks of start of study treatment.
- The patient had prior grade 3 immune related toxicity due to immune checkpoint inhibitors or non-infectious pneumonitis.
- The participant has received more than 2 prior chemotherapy lines.
- The participant has a history of tumor bleeding one month before study enrollment.
- The participant has received a live vaccine within 30 days prior to the first dose of study drug.
- The participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note...
- The participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7...
- The participant has a known active second/additional malignancy that is progressing or has required active treatment within the past 5 years Note: Exceptions include basal cell carcinoma of the skin, squamous cell...
- The participant has a known active CNS metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without...
- The participant has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of excipients.
- The participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement...
- The participant has an active infection requiring systemic therapy.
- The participant has a known history of human immunodeficiency virus (HIV 1/2 antibodies).
- The participant has a known history of hepatitis B or known active hepatitis C virus
- The participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of...
- The participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- The participant has had an active allogenic tissue/solid organ transplant.
- The participant has uncontrolled blood pressure
- The participant has clinically significant electrolyte abnormalities that have not been corrected.
- The participant has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident...
- The participant has bleeding or thrombotic disorders, radiographic evidence of major blood vessel invasion/infiltration, or is at risk for severe hemorrhage. Note: The degree of tumor invasion/infiltration of major...
- The participant has \>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours.
- Prolongation of QTc interval to \>480 ms.
- Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
- The participant has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
- The participant has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
- The participant has a known intolerance to the study treatment (or any of its excipients).
The study team makes the final eligibility decision.
Where it's taking place
- Ramat Gan, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ramat Gan, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.