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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Endometrial Cancer (LEAP-001 Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention
Must not have
Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, or anti-PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
Has a pre-existing Grade ≥3 gastrointestinal or nongastrointestinal fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 51 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effectiveness of a new immunotherapy drug combination to chemotherapy for women with advanced endometrial cancer. The hypothesis is that the immunotherapy combo will be better than chemo in terms of progression-free survival and overall survival.

Who is the study for?
This trial is for women with advanced (Stage III or IV) or recurrent endometrial carcinoma. Participants must have a performance status indicating they can carry out daily activities with little to no assistance, controlled blood pressure, and adequate organ function. They should not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.
What is being tested?
The study tests the effectiveness of pembrolizumab plus lenvatinib against standard chemotherapy in improving survival without cancer progression. It's designed to see if this combination works better than chemotherapy alone for patients with certain stages of endometrial cancer.
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, nausea, decreased appetite, weight loss, urinary tract infections, protein in urine, headache, vomiting and joint/muscle pain from Lenvatinib; immune-related adverse effects like inflammation in organs from Pembrolizumab; hair loss and nerve damage from Paclitaxel; low blood counts leading to infection risk from Carboplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have provided a sample of my tumor for MMR status testing.
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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 have been treated with drugs targeting cancer blood vessel growth or specific immune checkpoints.
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I have a severe fistula.
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My scans show cancer has spread to major blood vessels.
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I had treatment for brain metastasis and stopped steroids over 4 weeks ago.
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I have received an organ or tissue transplant from another person.
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I am currently on medication for an infection.
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I have a condition that affects how my body absorbs medication.
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I haven't had serious heart problems in the last year.
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I am still recovering from major surgery complications.
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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 have a specific type of uterine cancer.
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I have a history of hepatitis B or active hepatitis C.
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I have received hormonal therapy for endometrial cancer within the last week.
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I have or had lung inflammation treated with steroids.
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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 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
OS in All Randomized Participants
Overall Survival (OS) in pMMR Participants
PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
+1 more
Secondary study objectives
Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized Participants
Mean Change From Baseline in the Global Health Status/Quality of Life Score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR Participants
ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
+5 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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

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 + PembrolizumabExperimental Treatment2 Interventions
Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Group II: Paclitaxel + CarboplatinActive Control2 Interventions
Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Lenvatinib
2017
Completed Phase 4
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,367 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,784 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,184,385 Total Patients Enrolled
22 Trials studying Endometrial Cancer
4,865 Patients Enrolled for Endometrial Cancer
Eisai Inc.Industry Sponsor
521 Previous Clinical Trials
158,993 Total Patients Enrolled
1 Trials studying Endometrial Cancer
133 Patients Enrolled for Endometrial Cancer

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03884101 — Phase 3
Endometrial Cancer Research Study Groups: Lenvatinib + Pembrolizumab, Paclitaxel + Carboplatin
Endometrial Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT03884101 — Phase 3
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03884101 — Phase 3
~128 spots leftby Nov 2025
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