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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer (NCT04519151) is a Phase 2 interventional studying Ovarian Neoplasms and Carcinoma, Ovarian Epithelial, sponsored by Sheba Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Neoplasms and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Female participants who are at least 18 years of age on the day of signing willing to sign a consent form, with histologically-confirmed diagnosis of EOC (except from low grade tumors and mucinous histology). 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. 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. 3. The participant (or legally acceptable representative if applicable) provides written willing to sign a consent form for the trial. 4. Have measurable disease at baseline based on RECIST 1.1. Lesions 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. 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 months following completion of platinum-based therapy. Note: Maintenance treatment following front-line treatment is permitted and counted together as part of the front-line treatment. Recurrence is evaluated since last platinum-based chemotherapy administration (for patients treated with maintenance bevacizumab or PARP inhibitors) Note: Patients that received maintenance immune checkpoint inhibitors will be eligible if progression was documented over 6 months since completion of the immunotherapy maintenance treatment. Have received 0 to 1 line of chemotherapy for ROC (or 1 to 2 total prior lines counting the front line) and must have a PFI (or treatment-free interval) of \>6 months for each treatment line. 8\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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). 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. 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. 3. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 4. Have measurable disease at baseline based on RECIST 1.1. Lesions 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. 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 months following completion of platinum-based therapy. Note: Maintenance treatment following front-line treatment is permitted and counted together as part of the front-line treatment. Recurrence is evaluated since last platinum-based chemotherapy administration (for patients treated with maintenance bevacizumab or PARP inhibitors) Note: Patients that received maintenance immune checkpoint inhibitors will be eligible if progression was documented over 6 months since completion of the immunotherapy maintenance treatment. Have received 0 to 1 line of chemotherapy for ROC (or 1 to 2 total prior lines counting the front line) and must have a PFI (or treatment-free interval) of \>6 months for each treatment line. 8\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. 9\. Have adequately controlled blood pressure (BP) with or without antihypertensive medications 10. Have adequate organ function as defined by blood tests. Exclusion Criteria: 1. A WOCBP who has a positive urine pregnancy test 2. 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. 3. 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). 4. 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. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. 5. The participant has received prior lenvatinib. 6. The participant has received prior radiotherapy within 2 weeks of start of study treatment. 7. The patient had prior grade 3 immune related toxicity due to immune checkpoint inhibitors or non-infectious pneumonitis. 8. The participant has received more than 2 prior chemotherapy lines. 9. The participant has a history of tumor bleeding one month before study enrollment. 10. The participant has received a live vaccine within 30 days prior to the first dose of study drug. 11. 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: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 12. 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 days prior to the first dose of study drug. Note: The use of physiologic doses of corticosteroids is allowed. 13. 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 carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer. 14. 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 evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 15. The participant has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of excipients. 16. 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 therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 17. The participant has an active infection requiring systemic therapy. 18. The participant has a known history of human immunodeficiency virus (HIV 1/2 antibodies). 19. The participant has a known history of hepatitis B or known active hepatitis C virus 20. 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 study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 21. The participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 22. The participant has had an active allogenic tissue/solid organ transplant. 23. The participant has uncontrolled blood pressure 24. The participant has clinically significant electrolyte abnormalities that have not been corrected. 25. 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 (CVA) within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability requiring medical treatment at Screening. 26. 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 blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy. 27. 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. 28. Prolongation of QTc interval to \>480 ms. 29. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO). 30. The participant has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib. 31. The participant has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula. 32. The participant has a known intolerance to the study treatment (or any of its excipients).

Treatments Being Tested

DRUG

Pembrolizumab

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

DRUG

Lenvatinib

20 mg administered orally (PO) QD during each 21-day cycle.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sheba Medical center
Ramat Gan, Israel

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04519151), the sponsor (Sheba Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04519151 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04519151?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04519151?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04519151. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04519151. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.