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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

Must not have

Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Pregnant women are excluded from this study because the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenvatinib, breastfeeding should be discontinued if the mother is treated lenvatinib. These potential risks may also apply to other agents used in this study

Patients who have a history of a small or large bowel obstruction within 2 weeks of screening or who have and active partial small bowel obstruction or percutaneous endoscopic gastrostomy (PEG)-tube

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have been diagnosed with cancer in my uterus, ovaries, fallopian tubes, or the lining of my abdomen.

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I am 18 years or older and have given my consent to participate.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have had a bowel blockage or currently have a partial blockage or a PEG-tube.

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I have had pneumonitis treated with steroids or have it now.

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I haven't had any major bleeding issues in the last 6 months.

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I have an active tuberculosis infection.

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I do not have HIV or I am not on HIV medication.

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I cannot swallow pills or have a condition that affects drug absorption.

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I do not have active stomach ulcers, inflammatory bowel diseases, or recent severe abdominal issues.

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I do not have a serious infection or one needing IV antibiotics.

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I do not have a history of clotting disorders.

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I have a serious heart condition.

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I have not had major surgery within the last 4 weeks.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have a wound, bone fracture, or skin ulcer that is not healing.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I do not have severe nerve pain or damage.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year 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 tumor response

Secondary study objectives

Progression free survival

Safety and Toxicity

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

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: 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

2017

Completed Phase 4

~2070

Paclitaxel

2011

Completed Phase 4

~5450