Actively Recruiting
Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer
Led by Sheba Medical Center · Updated on 2023-06-08
24
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older with confirmed epithelial ovarian cancer, excluding low grade tumors and mucinous histology
- Not pregnant or breastfeeding, and either not of childbearing potential or agreeing to use contraception during treatment and for 120 days afterward
- Provided written informed consent
- Have measurable disease at baseline based on RECIST 1.1
- Have an ECOG performance status of 0 to 1
- Received frontline platinum-based chemotherapy after surgery with disease recurrence at least 6 months after completion
- Received 0 to 1 prior chemotherapy line for recurrent ovarian cancer with platinum-free interval over 6 months
- Provided tumor tissue sample or biopsy from a lesion not previously irradiated
- Have adequately controlled blood pressure with or without medication
- Have adequate organ function per blood tests
You will not qualify if you...
- Positive pregnancy test or pregnant, breastfeeding, or planning to conceive during the study and 120 days afterward
- Received anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor therapies within 6 months
- Received systemic anticancer therapy including investigational agents within 4 weeks before study start, except certain TKIs and hormonal therapies with shorter intervals
- Prior treatment with lenvatinib
- Radiotherapy within 2 weeks before study treatment
- Prior grade 3 immune-related toxicity or non-infectious pneumonitis
- More than 2 prior chemotherapy lines
- History of tumor bleeding within 1 month before enrollment
- Received live vaccine within 30 days before first dose
- Participation in other investigational studies within 4 weeks before first dose
- Immunodeficiency or chronic systemic steroid therapy above physiologic doses within 7 days before first dose
- Active second malignancy requiring treatment within past 5 years (with some exceptions)
- Active CNS metastases or carcinomatous meningitis unless stable for 4 weeks
- Severe hypersensitivity to pembrolizumab or excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Known HIV or active hepatitis B or C infection
- Conditions or treatments interfering with study participation or safety
- Psychiatric or substance abuse disorders interfering with trial compliance
- Active allogenic tissue or organ transplant
- Uncontrolled blood pressure
- Significant electrolyte abnormalities
- Significant cardiovascular impairment including certain heart conditions within 6 months
- Bleeding or thrombotic disorders or major blood vessel invasion increasing hemorrhage risk
- Proteinuria >1+ on dipstick unless 24-hour urine protein <1 g
- QTc interval >480 ms
- Reduced left ventricular ejection fraction below normal institutional range
- Gastrointestinal conditions affecting lenvatinib absorption
- Pre-existing grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Known intolerance to study treatment or excipients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sheba Medical center
Ramat Gan, Israel
Actively Recruiting
Research Team
R
Ronnie Shapira, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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