Actively Recruiting
A Phase II Open Label Single Arm Trial to Evaluate Lenvatinib with Pembrolizumab for Platinum-Sensitive Recurrent Ovarian Cancer
Led by Sheba Medical Center · Updated on 2023-06-08
24
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pembrolizumab and lenvatinib for treating platinum-sensitive recurrent ovarian cancer in this phase 2, open-label, single-arm study. The study focuses on adult female patients with confirmed epithelial ovarian cancer, excluding low-grade tumors and mucinous types, who have experienced disease recurrence after surgery and prior platinum-based chemotherapy. The goal is to assess the effect of this combination therapy on disease progression and overall patient outcomes. Participants will receive oral lenvatinib 20 mg daily alongside intravenous pembrolizumab 200 mg every three weeks for up to 35 treatment cycles or until disease progression or unacceptable toxicity. If participants complete pembrolizumab treatment or achieve complete response, they may continue lenvatinib alone or reinitiate pembrolizumab with or without lenvatinib for up to one year upon disease progression. The treatment is carefully monitored with dose adjustments allowed for lenvatinib in response to side effects. During the study, participants will undergo regular imaging with CT or MRI scans every nine weeks to track disease status. Safety is evaluated through adverse event monitoring using standardized criteria, along with laboratory tests and blood pressure checks. Quality of life assessments will be conducted using validated questionnaires. Additionally, biological samples including tumor biopsies, blood, stool, and vaginal swabs will be collected to study biomarkers and treatment response. The study lasts up to approximately 27 months, including follow-up and potential extended treatment phases.
CONDITIONS
Brief 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 histologically confirmed epithelial ovarian cancer, excluding low-grade tumors and mucinous histology
- Not pregnant or breastfeeding, and either not a woman of childbearing potential or agreeing to use contraception during treatment and for 120 days after
- Provided written informed consent
- Measurable disease at baseline based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Received frontline platinum-based chemotherapy after debulking surgery with documented disease recurrence at least 6 months after
- Received 0 to 1 line of chemotherapy for recurrent ovarian cancer with a platinum-free interval greater than 6 months
- Provided archival tumor tissue or new biopsy sample
- Adequately controlled blood pressure
- Adequate organ function as defined by blood tests
You will not qualify if you...
- Woman of childbearing potential with positive pregnancy test
- Pregnant, breastfeeding, or expecting to conceive during study and 120 days after last dose
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents within 6 months
- Received systemic anti-cancer therapy, investigational agents, or radiotherapy within specified recent timeframes
- Prior lenvatinib 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
- Live vaccine within 30 days before first dose
- Current participation in another investigational study within 4 weeks
- Immunodeficiency or recent immunosuppressive therapy exceeding physiologic doses
- Active second malignancy requiring treatment within past 5 years (with exceptions)
- Active CNS metastases or carcinomatous meningitis unless stable
- Severe hypersensitivity to pembrolizumab or excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Known HIV, hepatitis B, or active hepatitis C
- Conditions or therapies that interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Prior allogenic tissue or solid organ transplant
- Uncontrolled blood pressure
- Significant electrolyte abnormalities
- Significant cardiovascular impairment or recent major cardiac events
- Bleeding or thrombotic disorders or major vessel invasion
- Proteinuria exceeding specified limits
- Prolonged QTc interval or low left ventricular ejection fraction
- Gastrointestinal conditions affecting lenvatinib absorption
- Pre-existing grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Known intolerance to study treatments or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent, eligibility assessments, and baseline sample collection
Duration - Up to approximately 2 years (35 cycles of 21 days each)
Participants receive pembrolizumab by IV infusion every 3 weeks plus daily oral lenvatinib for up to 35 cycles until disease progression, unacceptable toxicity, or completion of treatment.
IV infusions every 3 weeks and daily oral medication; radiological evaluations every 9 weeks; multiple blood and tissue sample collections during treatment
Duration - Up to 1 year
Participants who stop initial treatment for reasons other than disease progression or intolerability, or attain complete response, may receive up to 1 year of pembrolizumab ± lenvatinib upon disease progression.
Pembrolizumab infusions every 3 weeks and daily oral lenvatinib as applicable; assessments continue as needed
Duration - Variable duration until progression or withdrawal
Participants who complete pembrolizumab treatment continue lenvatinib alone until disease progression, unacceptable toxicity, or withdrawal of consent.
Ongoing daily oral lenvatinib; regular monitoring visits as scheduled
Trial Site Locations
Total: 1 location
1
Sheba Medical center
Ramat Gan, Israel
Actively Recruiting
Research Team
R
Ronnie Shapira, MD
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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