Pembrolizumab and Lenvatinib in Advanced Cervical Cancer
- Conditions
- Cervical CancerMetastatic Cervical Cancer
- Registration Number
- NCT04865887
- Lead Sponsor
- Georgetown University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Female participants who are at least 18 years of age on the day of signing informed<br> consent with histologically confirmed diagnosis of locally advanced or metastatic<br> cervical cancer will be enrolled in this study.<br><br> 2. Patients with progression or intolerance to at least one line of therapy in the<br> locally advanced or metastatic setting will be eligible for this study.<br><br> 3. A female participant is eligible to participate if she is not pregnant, not<br> breastfeeding, and at least one of the following conditions applies:<br><br> 1. Not a woman of childbearing potential (WOCBP) as defined OR<br><br> 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment<br> period and for at least 120 days after the last dose of study treatment.<br><br> 4. The participant (or legally acceptable representative if applicable) provides<br> written informed consent for the trial.<br><br> 5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously<br> irradiated area are considered measurable if progression has been demonstrated in<br> such lesions.<br><br> 6. Have provided archival tumor tissue sample or newly obtained core or excisional<br> biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin<br> embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are<br> preferred to archived tissue. Note: If submitting unstained cut slides, newly cut<br> slides should be submitted to the testing laboratory within 14 days from the date<br> slides are cut.<br><br> 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.<br> Evaluation of ECOG is to be performed within 28 days prior to the date of treatment<br> initiation.<br><br> 8. Have adequate organ function as defined. Specimens must be collected within 28 days<br> prior to the start of study treatment.<br><br> 1. Absolute neutrophil count (ANC) =1500/µL<br><br> 2. Platelets =100 000/µL<br><br> 3. Hemoglobin =9.0 g/dL<br><br> 4. Creatinine OR Measured or calculated creatinine clearance (GFR can also be used<br> in place of creatinine or CrCl) =1.5 × ULN OR =30 mL/min for participant with<br> creatinine levels >1.5 × institutional ULN<br><br> 5. Total bilirubin =1.5 ×ULN OR direct bilirubin =ULN for participants with total<br> bilirubin levels >1.5 × ULN<br><br> 6. AST (SGOT) and ALT (SGPT) =2.5 × ULN (=5 × ULN for participants with liver<br> metastases)<br><br> 7. International normalized ratio (INR) OR prothrombin time (PT), Activated<br> partial thromboplastin time (aPTT) =1.5 × ULN unless participant is receiving<br> anticoagulant therapy as long as PT or aPTT is within therapeutic range of<br> intended use of anticoagulants<br><br>Exclusion Criteria:<br><br> 1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment<br> initiation. If the urine test is positive or cannot be confirmed as negative, a<br> serum pregnancy test will be required.<br><br> 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.<br><br> 3. Has received prior systemic anti-cancer therapy including investigational agents<br> within 4 weeks Note: Participants must have recovered from all AEs due to previous<br> therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be<br> eligible.Note: If participant received major surgery, they must have recovered<br> adequately from the toxicity and/or complications from the intervention prior to<br> starting study treatment.<br><br> 4. Has received prior radiotherapy within 2 weeks of start of study treatment.<br> Participants must have recovered from all radiation-related toxicities, not require<br> corticosteroids, and not have had radiation pneumonitis. A 1-week washout is<br> permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous<br> system (CNS) disease.<br><br> 5. Has received a live vaccine or live attenuated vaccine within 30 days prior to the<br> first dose of study drug. Administration of killed vaccines is allowed.<br><br> 6. Is currently participating in or has participated in a study of an investigational<br> agent or has used an investigational device within 4 weeks prior to the first dose<br> of study treatment.<br><br> 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy<br> (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of<br> immunosuppressive therapy within 7 days prior to the first dose of study drug.<br><br> 8. Has a known additional malignancy that is progressing or has required active<br> treatment within the past 3 years. Note: Participants with basal cell carcinoma of<br> the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast<br> carcinoma) that have undergone potentially curative therapy are not excluded.<br><br> 9. Has known active CNS metastases and/or carcinomatous meningitis. Participants with<br> previously treated brain metastases may participate provided they are radiologically<br> stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging<br> (note that the repeat imaging should be performed during study screening),<br> clinically stable and without requirement of steroid treatment for at least 14 days<br> prior to first dose of study treatment.<br><br> 10. Has severe hypersensitivity (=Grade 3) to pembrolizumab or lenvatinib and/or any of<br> their excipients.<br><br> 11. Has active autoimmune disease that has required systemic treatment in the past 2<br> years (i.e. with use of disease modifying agents, corticosteroids or<br> immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or<br> physiologic corticosteroid replacement therapy for adrenal or pituitary<br> insufficiency, etc.) is not considered a form of systemic treatment.<br><br> 12. Has a history of (non-infectious) pneumonitis/interstitial lung disease that<br> required steroids or has current pneumonitis/interstitial lung disease.<br><br> 13. Has an active infection requiring systemic therapy.<br><br> 14. Has a known history of Human Immunodeficiency Virus (HIV).<br><br> 15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]<br> reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is<br> detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required<br> unless mandated by local health authority.<br><br> 16. Has a history or current evidence of any condition, therapy, or laboratory<br> abnormality that might confound the results of the study, interfere with the<br> subject's participation for the full duration of the study, or is not in the best<br> interest of the subject to participate, in the opinion of the treating investigator.<br><br> 17. Has known psychiatric or substance abuse disorders that would interfere with<br> cooperation with the requirements of the trial.<br><br> 18. Is pregnant or breastfeeding, or expecting to conceive or father children within the<br> projected duration of the study, starting with the screening visit through 120 days<br> after the last dose of trial treatment.<br><br> 19. Has uncontrolled blood pressure (BP) (Systolic BP>140 mmHg or diastolic BP>90 mmHg)<br> in spite of an optimized regimen of antihypertensive medication.<br><br> 20. Has electrolyte abnormalities that have not been corrected.<br><br> 21. Has signifi
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate
- Secondary Outcome Measures
Name Time Method Duration of response;Progression Free survival;Overall survival;Incidence of adverse events;Incidence of study drug discontinuation due to Adverse Events