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Tyrosine Kinase Inhibitor
Triple-Drug Combo for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by Floor Backes, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with histologically confirmed endometrial cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (all histological subtypes)
Participants who are at least 18 years of age on the day of signing informed consent will be enrolled in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trialwill study a 3-drug combo for recurrent endometrial & ovarian cancer to see if it's safe & effective w/ manageable side effects.
Who is the study for?
This trial is for women at least 18 years old with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer who have had platinum-based treatment. They must not be pregnant or breastfeeding and should have an acceptable organ function. Prior treatments are allowed under certain conditions but no recent severe side effects from similar drugs.Check my eligibility
What is being tested?
The study tests a combination of three FDA-approved drugs: Lenvatinib, Pembrolizumab, and Paclitaxel in patients with specific recurrent cancers. The goal is to determine the effectiveness and safety of this triple-drug regimen which has not been studied before.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation (like inflammation), issues from drug infusion into the body, fatigue, digestive problems such as nausea or diarrhea, blood-related complications like anemia or clotting disorders, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cancer in my uterus, ovaries, fallopian tubes, or the lining of my abdomen.
Select...
I am 18 years or older and have given my consent to participate.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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
Objective tumor response
Secondary outcome measures
Progression free survival
Safety and Toxicity
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, lenvatinib, pembrolizumab)Experimental Treatment3 Interventions
Patients receive paclitaxel IV over 1 hour on days -15 and -8 and lenvatinib PO QD on days -15 to 0. Beginning cycle 1 day 1, patients receive lenvatinib PO QD, pembrolizumab IV over 30 minutes on day 1, and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles with pembrolizumab repeats every 3 weeks for up to 2 years, and cycles with paclitaxel and lenvatinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Floor Backes, MDLead Sponsor
Floor BackesLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinoma
26 Patients Enrolled for Fallopian Tube Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have had a bowel blockage or currently have a partial blockage or a PEG-tube.I have had pneumonitis treated with steroids or have it now.I haven't had any major bleeding issues in the last 6 months.I have another cancer besides skin or in situ cancers that needed treatment in the last 3 years.I have an active tuberculosis infection.I do not have HIV or I am not on HIV medication.I cannot swallow pills or have a condition that affects drug absorption.I do not have active stomach ulcers, inflammatory bowel diseases, or recent severe abdominal issues.My ovarian, fallopian tube, or peritoneal cancer is resistant to platinum-based treatments.I do not have a serious infection or one needing IV antibiotics.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L within the last 10 days before starting the study treatment.Your kidney function should be measured according to the hospital's usual method.I am severely allergic to pembrolizumab, lenvatinib, or paclitaxel.My cancer may or may not have mismatch repair deficiency.I am a woman who can become pregnant and have tested positive for pregnancy recently.I have a history of hepatitis B or active hepatitis C.I've had 1-3 treatments with platinum-based drugs for my condition, not counting hormonal or maintenance therapy.My blood clotting tests are normal or within the treatment range if I'm on blood thinners.My kidney function is within the required range for the study.Your bilirubin levels must be within a certain range before starting the study treatment.I am not pregnant, not breastfeeding, and meet one of the required conditions.I have been diagnosed with cancer in my uterus, ovaries, fallopian tubes, or the lining of my abdomen.I haven't had blood clots or major blood vessel problems in the last 6 months.I have previously been treated with PD-1/PD-L1 inhibitors or weekly paclitaxel, but not as my last treatment and not stopped due to side effects.I have stable brain metastases and haven't needed steroids for 14 days.I have not received a live vaccine in the last 30 days, except for the flu shot.I do not have a history of clotting disorders.I am 18 years or older and have given my consent to participate.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have a serious heart condition.I have not had major surgery within the last 4 weeks.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have a wound, bone fracture, or skin ulcer that is not healing.My liver function tests are within the required range.I had radiotherapy over 3 weeks ago, with no ongoing side effects and didn't need steroids.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't had a blood clot or lung clot in the last 3 months, or if I have, it's been stable or better for over 3 months on blood thinners.I have had targeted therapy for cancer without stopping due to side effects.Your white blood cell count is at least 1500 per microliter.My cancer can be measured and has grown in areas previously treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.I do not have severe nerve pain or damage.I have provided a recent or past biopsy of my tumor that was not treated with radiation.Your platelet count is at least 100,000 per microliter within the last 10 days before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (paclitaxel, lenvatinib, pembrolizumab)
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.
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