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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Ovarian Cancer

Phase 2
Recruiting
Led By Elizabeth K Lee, MD
Research Sponsored by Elizabeth K. Lee MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease
Must not have
Evidence of bowel involvement
Any gastrointestinal disorder that would interfere with the passage or absorption of oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease will be evaluated every 3 cycles on treatment (each cycle is 3 weeks); treatment continues until disease progression or unacceptable toxicity. treatment duration is expected to be up to 3 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the combination of pembrolizumab and lenvatinib in patients with clear cell ovarian cancer that has returned or not responded to treatment. Pembrolizumab boosts the immune system to fight cancer, and lenvatinib blocks proteins that help cancer grow. These medications have been used together for various cancers, showing promising results.

Who is the study for?
This trial is for adults over 18 with recurrent or persistent clear cell ovarian cancer who've had at least one platinum-based chemotherapy. They must have measurable disease, stable health status (ECOG 0 or 1), adequate organ function, controlled blood pressure, and no major recent surgeries. Women of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
The study tests the combination of pembrolizumab and lenvatinib in treating clear cell ovarian cancer. It aims to determine how safe and effective this drug duo is when given together to patients who meet specific health criteria.
What are the potential side effects?
Potential side effects may include high blood pressure, fatigue, loss of appetite, thyroid dysfunction, nausea, mouth sores, rash or redness on hands/feet. More serious risks involve immune system reactions that could affect lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had platinum-based chemotherapy for my disease.
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My ovarian cancer is mainly clear cell type.
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I have at least one cancer lesion that can be measured.
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I am fully active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my intestines.
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I do not have stomach or bowel problems affecting medication absorption.
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My urine protein is less than 1g/24 hours.
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I have not had serious bleeding in the last 4 weeks.
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I have previously taken lenvatinib.
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I have not had radiation therapy in the last 2 weeks.
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I haven't had any cancer treatment in the last 4 weeks.
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I have received an organ or tissue transplant from another person.
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I have been diagnosed with an immune system disorder.
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I am allergic to lenvatinib, pembrolizumab, or similar drugs.
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I have a serious heart condition.
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I have not had major surgery in the last 4 weeks.
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I have tested positive for Hepatitis B or C.
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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease will be evaluated every 3 cycles on treatment (each cycle is 3 weeks); treatment continues until disease progression or unacceptable toxicity. treatment duration is expected to be up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease will be evaluated every 3 cycles on treatment (each cycle is 3 weeks); treatment continues until disease progression or unacceptable toxicity. treatment duration is expected to be up to 3 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
6 Month Progression-free survival (PFS) Rate
Overall Response Rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR)
Grade 3 or Higher Treatment-Related Toxicity Rate
Median Overall Survival (OS)
+7 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%
Clostridium difficile colitis
1%
Systemic infection
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
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

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 and LENVATINIBExperimental Treatment2 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Lenvatinib * Pembrolizumab Treatment will continue until progression of disease or unacceptable toxicity. Participants will be followed for up to 36 months after discontinuation of study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2017
Completed Phase 4
~2040
Pembrolizumab
2017
Completed Phase 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab, an immune checkpoint inhibitor, works by targeting the PD-1 receptor on T-cells, thereby preventing cancer cells from evading immune detection and destruction. Lenvatinib, a tyrosine kinase inhibitor, blocks multiple pathways that promote tumor growth and angiogenesis. These mechanisms are significant for ovarian carcinoma patients as they offer a dual approach: enhancing the immune system's ability to target cancer cells and directly inhibiting tumor proliferation and blood supply, potentially leading to better treatment outcomes.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,996 Previous Clinical Trials
5,181,211 Total Patients Enrolled
40 Trials studying Ovarian Cancer
6,208 Patients Enrolled for Ovarian Cancer
Elizabeth K. Lee MDLead Sponsor
Elizabeth K Lee, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05296512 — Phase 2
Ovarian Cancer Research Study Groups: PEMBROLIZUMAB and LENVATINIB
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296512 — Phase 2
~6 spots leftby May 2025
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