← Back to Search

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
Must not have
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of Hepatitis B or active Hepatitis C.
Select...
I do not have serious heart problems like recent heart attacks or severe heart failure.
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
I have been diagnosed with HIV.
Select...
I have or had lung inflammation not caused by infection, treated with steroids.
Select...
My blood pressure is high despite taking medication.
Select...
I have an autoimmune disease treated with strong medication in the last 2 years.
Select...
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Select...
I am currently being treated for an infection.
Select...
I have a condition that affects how my body absorbs medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate
Secondary study objectives
Duration of response
Incidence of adverse events
Incidence of study drug discontinuation due to Adverse Events
+2 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~3150
Lenvatinib
2017
Completed Phase 4
~2070

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
348 Previous Clinical Trials
137,267 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,298 Total Patients Enrolled
Samir Khleif, MDPrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04865887 — Phase 2
Cervical Cancer Research Study Groups: Pembrolizumab with Lenvatinib
Cervical Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04865887 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04865887 — Phase 2
~8 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top