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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Endometrial Cancer

Phase 3

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR

Has a histologically confirmed diagnosis of endometrial carcinoma (EC)

Must not have

Has carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas

Has had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of study drug up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether pembrolizumab and lenvatinib prolongs progression free survival and overall survival for endometrial cancer patients when compared to standard treatment.

Who is the study for?

This trial is for adults with advanced endometrial cancer who've had one prior platinum-based chemotherapy. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain other cancers, heart conditions, active infections, HIV/Hepatitis B/C, recent major surgery complications, autoimmune diseases requiring treatment in the past 2 years, or previous treatments that overlap with the study drugs.

What is being tested?

The trial tests pembrolizumab combined with lenvatinib against a physician's choice of doxorubicin or paclitaxel in treating advanced endometrial cancer. The goal is to see if the combination improves survival without disease progression compared to standard treatments.

What are the potential side effects?

Potential side effects include fatigue, nausea, increased blood pressure from lenvatinib; immune-related reactions like skin rash or thyroid issues from pembrolizumab; and hair loss (alopecia), heart toxicity from doxorubicin; nerve damage and allergic reactions from paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor that can be measured and has been confirmed by a review.

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I have been diagnosed with endometrial carcinoma.

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My cancer has come back or spread from its original site.

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I have a tumor biopsy for MMR status testing.

Exclusion Criteria

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

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My cancer is a specific type affecting the uterus.

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I have received an organ or tissue transplant from another person.

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I have been treated with drugs targeting blood vessel growth or drugs that boost the immune system.

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I stopped a specific immune treatment due to severe side effects.

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I have a severe abnormal connection between my organs.

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I have had serious heart problems or a stroke in the last year.

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I have or had lung inflammation treated with steroids.

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I haven't had any cancer except for certain skin cancers or treated in-situ cancers in the last 2 years.

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My scans show cancer has spread to major blood vessels.

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I had cancer treatment within the last 28 days and have no major side effects.

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I am currently being treated for an infection.

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I have an autoimmune disease, other than psoriasis, treated in the last 2 years.

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I have not received a live vaccine in the last 30 days.

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My heart's pumping ability is below normal.

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My brain metastases are not stable.

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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 am HIV positive.

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I have a condition that affects how my body absorbs medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization up to first documentation of pd or date of death, whichever occurred first up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization up to first documentation of pd or date of death, whichever occurred first up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to first documentation of pd or date of death, whichever occurred first up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression-free Survival (PFS)

Secondary study objectives

Health-Related Quality of Life (HRQoL) Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQC30) Score

Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib

Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib

+4 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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lenvatinib 20 mg + Pembrolizumab 200 mgExperimental Treatment2 Interventions

Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.

Group II: Treatment of Physician's ChoiceActive Control2 Interventions

Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m\^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m\^2 OR paclitaxel 80 mg/m\^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Lenvatinib

2017

Completed Phase 4

~2070