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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
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
Study Summary
This trial is evaluating the efficacy and safety of combining these two drugs in patients with clear cell ovarian cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 Month Progression-free survival (PFS) Rate
Overall Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Grade 3 or Higher Treatment-Related Toxicity Rate
Median Overall Survival (OS)
+7 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 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
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,640 Total Patients Enrolled
1 Trials studying Ovarian Carcinoma
160 Patients Enrolled for Ovarian Carcinoma
Elizabeth K. Lee MDLead Sponsor
Elizabeth K Lee, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer has spread to my intestines.I will stop taking herbal supplements at least 1 week before starting the study treatment.I have had platinum-based chemotherapy for my disease.I have had multiple treatments for my recurring or persistent disease.I do not have stomach or bowel problems affecting medication absorption.My urine protein is less than 1g/24 hours.I have not had serious bleeding in the last 4 weeks.I have previously taken lenvatinib.I have not received a live vaccine in the last 30 days.I haven't taken immunosuppressive drugs, including steroids, in the last 2 weeks.I have not had radiation therapy in the last 2 weeks.I have previously been treated with bevacizumab.I haven't had any cancer treatment in the last 4 weeks.I have side effects from cancer treatment, but only hair loss or nerve issues are serious.I have received an organ or tissue transplant from another person.I may have been treated with specific immune therapies before.My organs and bone marrow are functioning well.I can provide 27 slides of my tumor tissue for testing, with the most recent samples preferred.My ovarian cancer is mainly clear cell type.I have been diagnosed with an immune system disorder.I have at least one cancer lesion that can be measured.I am allergic to lenvatinib, pembrolizumab, or similar drugs.My blood pressure is under control, with or without medication.I have a serious heart condition.My brain cancer has been stable for 4 weeks, I've finished treatment, and haven't taken steroids in 4 weeks.I have not had major surgery in the last 4 weeks.I am fully active or able to carry out light work.I have tested positive for Hepatitis B or C.I have or had lung inflammation that needed steroids.
Research Study Groups:
This trial has the following groups:- Group 1: PEMBROLIZUMAB and LENVATINIB
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 the Food & Drug Administration sanctioned Pembrolizumab?
"While there is evidence to support its safety, the lack of data regarding efficacy means that Pembrolizumab received a score of 2."
Answered by AI
Is this research endeavor still looking to accept more participants?
"Affirmative. Records from clinicaltrials.gov validate that this medical experiment, which went live on September 23rd 2022, is still recruiting participants. The trial requires 31 patients to be enrolled at a single location."
Answered by AI
What is the maximum capacity for participants in this medical trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially published on September 23rd 2022, is recruiting participants at present. 31 patients are required for the study to take place at a single location."
Answered by AI
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