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Enzyme Inhibitor
Pembrolizumab + Lenvatinib for Ovarian Cancer
Phase 2
Recruiting
Led By Amir A Jazaeri
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants willing to undergo intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws
Must not have
Active autoimmune disease that has required systemic treatment in the past 2 years
Active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial is testing the effects of two drugs, pembrolizumab and lenvatinib, on patients with high-grade serous ovarian cancer. The drugs work in different ways to attack the cancer cells, and it is hoped that they will be more effective together than either one alone.
Who is the study for?
This trial is for adult women with high-grade serous ovarian, fallopian tube, or peritoneal cancers that are resistant to platinum-based treatments. Participants must have controlled blood pressure, good physical function (ECOG 0-1), and measurable disease in the peritoneal cavity or lymph nodes. They should not be pregnant and must agree to follow contraceptive guidance.Check my eligibility
What is being tested?
The trial studies pembrolizumab (an immunotherapy drug) combined with lenvatinib (an enzyme inhibitor) in treating patients. The goal is to see if this combination can help control the cancer by boosting the immune system's response and stopping cancer cell growth.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, liver issues, kidney problems, bleeding risks, gastrointestinal symptoms like diarrhea or nausea, immune-related reactions such as rash or thyroid dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I am willing to have a port placed in my abdomen for treatment and agree to scheduled fluid and blood tests.
Select...
My cancer has spread to the abdominal area or behind the stomach.
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My cancer is a high-grade serous type and does not respond to platinum-based treatments.
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My blood pressure is under control and hasn't required new medication in the last week.
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I am a woman aged 18 or older.
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My cancer is high grade serous and resistant to platinum-based treatments.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an autoimmune disease treated with medication in the last 2 years.
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I am currently on medication for an infection.
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I have received an organ or tissue transplant from another person.
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I have active brain metastases or cancer in the lining of my brain.
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I've had a severe increase in blood pressure with previous anti-VEGF treatment.
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I have been treated with lenvatinib before.
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I have been diagnosed with HIV.
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I haven't had serious heart problems in the last year.
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I have recovered from side effects of previous treatments to my normal or mild condition.
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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.
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I have or had lung inflammation that needed steroids.
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I have not taken immunosuppressive drugs or steroids in the last 7 days.
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I had another type of cancer but was treated successfully and have been cancer-free for 2 years.
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I recently had major surgery and haven't fully recovered.
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I have an active TB infection.
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I have a severe fistula.
Select...
My tumor is affecting a major blood vessel or has cavities inside it.
Select...
I have a history of chronic hepatitis B or C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the proportion of CD8+ and CD4+ cells that are Ki67+ at the monotherapy phase in comparison to the combination therapy phase of treatment.
Change in the proportion of CD8+ and CD4+ cells that are PD1+CD38+ at the monotherapy phase in comparison to the combination therapy phase of treatment.
Side 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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
2Treatment groups
Experimental Treatment
Group I: Cohort B (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions
Beginning cycle 0, patients receive lenvatinib PO QD on days 1-21. Beginning cycle 1, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Cohort A (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions
Beginning cycle 0, patients receive pembrolizumab IV over 30 minutes on day 1. Beginning cycle 1, patients also receive lenvatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2020
Completed Phase 4
~2650
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,249 Total Patients Enrolled
4 Trials studying Fallopian Tube Carcinoma
600 Patients Enrolled for Fallopian Tube Carcinoma
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
256 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease treated with medication in the last 2 years.My cancer can be measured and is present in my abdomen or lymph nodes near my spine.I am a woman aged 18 or older.I can understand and am willing to sign the consent form.You have mental health or drug addiction issues that could make it difficult for you to follow the study requirements.I am currently on medication for an infection.I've had a severe increase in blood pressure with previous anti-VEGF treatment.My cancer has spread to the abdominal area or behind the stomach.I have been diagnosed with HIV.You are not able to become pregnant or you agree to use birth control during the treatment and for at least 5 months after the treatment ends if you can become pregnant.I have been treated with lenvatinib before.My blood pressure is under control, with or without medication.I have active brain metastases or cancer in the lining of my brain.I can understand and am willing to sign the consent form before starting the study.I haven't had serious heart problems in the last year.I have received an organ or tissue transplant from another person.I had radiotherapy less than 2 weeks before starting the study treatment.I have recovered from side effects of previous treatments to my normal or mild condition.My hemoglobin level is at least 9.0 g/dL, transfusions included.An absolute neutrophil count (ANC) of at least 1500/uL, taken within 10 days prior to the start of study treatment, is required.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.My blood pressure is under control and hasn't required new medication in the last week.I haven't needed blood transfusions or erythropoietin in the last 2 weeks.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have not taken immunosuppressive drugs or steroids in the last 7 days.I have or had lung inflammation that needed steroids.I am willing to have a port placed in my abdomen for treatment and agree to scheduled fluid and blood tests.I am fully active or restricted in physically strenuous activity but can do light work.My blood clotting time is normal or near normal, even if I'm on blood thinners.My cancer is a high-grade serous type and does not respond to platinum-based treatments.I am willing to have a port placed in my abdomen for treatment and agree to scheduled fluid and blood tests.I have not received a live vaccine in the last 30 days.You have taken part in a study involving an experimental drug or device within the last 4 weeks.My kidney function, measured by creatinine levels or clearance, is within the required range.I had another type of cancer but was treated successfully and have been cancer-free for 2 years.I recently had major surgery and haven't fully recovered.I have an active TB infection.I have a severe fistula.My tumor is affecting a major blood vessel or has cavities inside it.I am a woman aged 18 or older.My cancer is high grade serous and resistant to platinum-based treatments.I am fully active or can carry out light work.I have a history of chronic hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (pembrolizumab, lenvatinib)
- Group 2: Cohort B (pembrolizumab, 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.
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