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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Advanced Cervical Cancer
Phase 2
Recruiting
Led By Samir Khleif, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of locally advanced or metastatic cervical cancer will be enrolled in this study.
Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat patients with cervical cancer that has spread and failed to respond to first line therapy. The hypothesis is that the combination of the two drugs will be more effective than either drug alone.
Who is the study for?
This trial is for women at least 18 years old with advanced cervical cancer that worsened after first-line therapy. They must have measurable disease, provide a tumor tissue sample, and have proper organ function. Women of childbearing potential must agree to contraception guidelines. Exclusions include severe allergies to the drugs tested, recent other treatments or vaccines, certain health conditions like uncontrolled blood pressure or active infections.Check my eligibility
What is being tested?
The trial tests pembrolizumab combined with lenvatinib in patients with advanced cervical cancer who didn't respond well to initial treatment. It's believed this combo could counteract VEGF-mediated immunosuppression and improve patient response.See study design
What are the potential side effects?
Possible side effects may include immune system reactions leading to inflammation in various organs, infusion-related reactions, fatigue, digestive issues such as malabsorption or gastrointestinal disorders, increased risk of infection due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 with advanced or metastatic cervical cancer.
Select...
My kidney function, measured by creatinine or GFR, is within the required range.
Select...
My cancer has worsened or I couldn't tolerate my first treatment.
Select...
I am not able to become pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration of response
Incidence of adverse events
Incidence of study drug discontinuation due to Adverse Events
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with LenvatinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,467 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,900 Total Patients Enrolled
Samir Khleif, MDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of Hepatitis B or active Hepatitis C.I do not have serious heart problems like recent heart attacks or severe heart failure.My brain metastases are stable, and I haven't needed steroids for 14 days.I haven't had cancer treatment or major surgery in the last 4 weeks and have recovered from side effects.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well, tested within the last 28 days.I had radiotherapy over 2 weeks ago, with no ongoing side effects and haven't needed steroids.I have another cancer besides skin or in situ cancers that needed treatment in the last 3 years.My cancer can be measured by scans and has grown in previously treated areas.I have not received a live vaccine within the last 30 days.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am a woman over 18 with advanced or metastatic cervical cancer.My kidney function, measured by creatinine or GFR, is within the required range.My cancer has worsened or I couldn't tolerate my first treatment.I can provide a recent or past biopsy of my tumor that hasn't been radiated.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or lenvatinib, or any ingredients in these medications.I have been diagnosed with HIV.I have or had lung inflammation not caused by infection, treated with steroids.My blood pressure is high despite taking medication.I have an autoimmune disease treated with strong medication in the last 2 years.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am currently being treated for an infection.I am not pregnant, not breastfeeding, and meet one of the specific conditions.My liver function tests are within the required range.I have a bleeding disorder or am at high risk for severe bleeding.I am not able to become pregnant.I have a condition that affects how my body absorbs medication.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab with Lenvatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab been given a seal of approval by the Food and Drug Administration?
"With limited clinical data to support its efficacy, pembrolizumab's safety rating is set at 2."
Answered by AI
Are there any opportunities left to participate in this research endeavor?
"Affirmative. According to information found on clinicaltrials.gov, this medical research has been open for recruitment since November 1st 2022 and was recently edited on September 27th 2022. The trial requires 35 volunteers at 3 different locations."
Answered by AI
Could you provide details on other trials involving Pembrolizumab that have been conducted previously?
"There are presently 1032 ongoing studies on pembrolizumab, with 134 in the third phase. Primarily situated around Sacramento, California, there are also 37065 other clinical trial sites providing this medication to participants."
Answered by AI
How many participants have been recruited for this medical experiment?
"Affirmative. Clinicaltrials.gov hosts data indicating that this clinical trial, first posted on November 1st 2022, is actively searching for participants. 35 individuals need to be recruited from 3 separate medical sites."
Answered by AI
What ailments has Pembrolizumab been found to be beneficial for managing?
"Pembrolizumab is most frequently prescribed to tackle malignant neoplasms; however, it can also be used in the treatment of unresectable melanoma, microsatellite instability-high tumors, and cases where chemotherapy has been unsuccessful."
Answered by AI
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