Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer (NCT05296512) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
United States30 participantsStarted 2022-09-23
Plain-language summary
This research study is being done to test the efficacy and safety of combining the study drugs pembrolizumab and lenvatinib in patients with clear cell ovarian cancer.
The names of the study drugs involved in this study are:
* Lenvatinib
* Pembrolizumab
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) (≥50% clear cell histology).
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST v1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.
* Prior bevacizumab is allowed.
* Prior use of immune checkpoint inhibitors (e.g. anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for up to 30% of participants.
* Unlimited prior lines for the treatment of recurrent or persistent disease are allowed.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of the combination of pembrolizumab/lenvatinib in participants \<18 years of age, children are excluded from this study.
* ECOG performance status of 0 or 1 (Karnofsky performance scale ≥70%).
* Participants must have adequate organ and marrow function as defined below:
* absolute neutrophil count ≥1,500/μcL
* hemoglobin ≥ 9g/dL (without use of erythropoietin; without packed RBC transfusion within preceding 2 weeks)
* platelet count ≥100,000/μcL
* total bilirubin ≤ institutional upper limit of normal (ULN) (in the absence of liver metastases) or ≤ 1.5 × institutional UL…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: ORR expected to be observed up to 3 years
2
6 Month Progression-free survival (PFS) Rate
Timeframe: Disease will be evaluated at baseline and every 3 cycles on treatment, where each cycle is 3 weeks. Relevant to this endpoint is the 6 month timepoint.