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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Endometrial Cancer
Phase 2
Recruiting
Led By Leslie Randall, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to swallow oral medications
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days (plus or minus 15 days) following last dose of study treatment
Awards & highlights
Study Summary
This trial will test how well a combination of lenvatinib and pembrolizumab works in Black participants compared to the efficacy reported in the historical trials.
Who is the study for?
This trial is for Black individuals with recurrent endometrial cancer that's mismatch repair-proficient. Participants must have received no more than two prior therapies (excluding maintenance and hormonal treatments), be postmenopausal or not of childbearing potential, and agree to contraception if applicable. They should have measurable disease, an ECOG status of 0-2, and be able to take oral meds. Those with treated/stable brain metastases may qualify.Check my eligibility
What is being tested?
The study tests the effectiveness of lenvatinib combined with pembrolizumab in Black patients compared to past trials' results leading to FDA approval. It aims to see how well this combination works specifically in a demographic underrepresented in previous studies.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, nausea, kidney problems from lenvatinib; immune-related reactions like skin issues or colitis from pembrolizumab; plus common chemotherapy side effects such as hair loss or mild anemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have a tumor or lymph node large enough to be measured by CT or MRI.
Select...
My endometrial cancer is confirmed and has gotten worse.
Select...
My cancer is microsatellite stable.
Select...
I agree to use birth control during and for 4 months after my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days (plus or minus 15 days) following last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days (plus or minus 15 days) following last dose of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the objective response rate (ORR) at 24 weeks in Black patients with recurrent endometrial cancer treated with lenvatinib 20 mg orally daily in combination with pembrolizumab 200 mg IV every 3 weeks
Secondary outcome measures
Determine the median progression free survival (PFS)
Determine the number of patients who discontinue treatment due to treatment-related adverse events (AEs)
Determine the number of patients with treatment-related adverse events (AEs) in the study population
Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155465%
Diarrhoea
61%
Hypertension
52%
Weight decreased
51%
Decreased appetite
42%
Vomiting
41%
Fatigue
40%
Nausea
39%
Dysphonia
33%
Stomatitis
31%
Proteinuria
29%
Constipation
28%
Palmar-plantar erythrodysaesthesia syndrome
27%
Cough
25%
Asthenia
24%
Abdominal pain
22%
Headache
22%
Arthralgia
21%
Oedema peripheral
21%
Back pain
19%
Dyspnoea
18%
Dysphagia
18%
Dizziness
16%
Epistaxis
16%
Rash
16%
Musculoskeletal pain
14%
Hypoalbuminaemia
14%
Myalgia
14%
Pain in extremity
13%
Insomnia
13%
Dyspepsia
13%
Hypocalcaemia
13%
Dry mouth
13%
Muscle spasms
13%
Musculoskeletal chest pain
13%
Abdominal pain upper
12%
Dry skin
12%
Dysgeusia
12%
Pyrexia
11%
Electrocardiogram QT prolonged
11%
Alopecia
11%
Glossodynia
11%
Oropharyngeal pain
11%
Haemoptysis
9%
Hypotension
9%
Alanine aminotransferase increased
8%
Anaemia
8%
Ejection fraction decreased
8%
Thrombocytopenia
8%
Hypothyroidism
8%
Toothache
7%
Pneumonia
7%
General physical health deterioration
7%
Blood creatinine increased
7%
Hypomagnesaemia
7%
Aspartate aminotransferase increased
7%
Urinary tract infection
7%
Neck pain
7%
Haemorrhoids
7%
Haematuria
7%
Nasopharyngitis
7%
Sinusitis
6%
Hyperglycaemia
6%
Bronchitis
6%
Depression
6%
Muscular weakness
6%
Hyponatraemia
6%
Blood thyroid stimulating hormone increased
6%
Oral pain
6%
Cheilitis
6%
Anxiety
6%
Malaise
6%
Blood alkaline phosphatase increased
6%
Upper respiratory tract infection
6%
Decubitus ulcer
5%
Dermatitis acneiform
5%
Lipase increased
4%
Death
4%
Non-cardiac chest pain
4%
Flank pain
4%
Atrial fibrillation
4%
Cerebrovascular accident
4%
Malignant neoplasm progression
4%
Metastatic pain
4%
Flatulence
4%
Productive cough
2%
Joint swelling
2%
Paraesthesia
2%
Pathological fracture
2%
Respiratory failure
2%
Hyperhidrosis
2%
Hypertensive crisis
2%
Gastrooesophageal reflux disease
2%
Dehydration
2%
Diverticular perforation
2%
Respiratory distress
2%
Platelet count decreased
2%
Gingival pain
1%
Aneurysm ruptured
1%
Febrile neutropenia
1%
Appendicitis perforated
1%
Abscess intestinal
1%
Eschar
1%
Anal abscess
1%
Blood uric acid increased
1%
Osteomyelitis
1%
Pneumothorax
1%
Spinal cord ischaemia
1%
Hypercalcaemia
1%
Cholecystitis
1%
Intracranial tumour haemorrhage
1%
Intestinal perforation
1%
Pleuritic pain
1%
Sepsis
1%
Acute respiratory distress syndrome
1%
Implant site infection
1%
Mesenteric artery thrombosis
1%
Pneumonia staphylococcal
1%
Splenic rupture
1%
Pneumonia necrotising
1%
Respiratory depression
1%
Pain
1%
Osmotic demyelination syndrome
1%
Pancreatitis
1%
Facial paresis
1%
Diabetic encephalopathy
1%
Cardiac failure
1%
Dyspnoea exertional
1%
Fungal skin infection
1%
Syncope
1%
Retinal detachment
1%
Dental cyst
1%
Blood cholesterol increased
1%
Acute myocardial infarction
1%
Confusional state
1%
Postmenopausal haemorrhage
1%
Gastroenteritis viral
1%
Hyperaesthesia
1%
Sciatica
1%
Empyema
1%
Urinary incontinence
1%
Pulmonary haemorrhage
1%
Subarachnoid haemorrhage
1%
Anal fistula
1%
Angioedema
1%
Atrial flutter
1%
Cardiac arrest
1%
Cauda equina syndrome
1%
Cellulitis
1%
Chest pain
1%
Cholelithiasis
1%
Chronic obstructive pulmonary disease
1%
Colonic abscess
1%
Coma
1%
Device breakage
1%
Diverticulitis
1%
Appendicitis
1%
Tachycardia
1%
Gastroenteritis
1%
Hypovolaemia
1%
Inguinal hernia
1%
Laryngeal necrosis
1%
Laryngeal obstruction
1%
Laryngeal oedema
1%
Lung disorder
1%
Lung infection
1%
Malignant pleural effusion
1%
Metastases to bone
1%
Hypokalaemia
1%
Cancer pain
1%
Palpitations
1%
Hepatocellular injury
1%
Mobility decreased
1%
Metastatic pulmonary embolism
1%
Dermatitis contact
1%
Thrombophlebitis
1%
Skin fissures
1%
Pyelonephritis
1%
Ventricular tachycardia
1%
Soft tissue necrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 24 mg
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab & LenvatinibExperimental Treatment2 Interventions
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,895 Total Patients Enrolled
Leslie Randall, MDPrincipal InvestigatorMassey Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects how my body absorbs medication.I can swallow pills.I do not have active hepatitis B or C.My cancer is one of the specific types: carcinosarcoma, leiomyosarcoma, or stromal sarcoma.I have had 2 or fewer previous cancer treatments, not counting maintenance or hormonal therapies.I have a history of lung scarring or inflammation not caused by infections.I have not been treated with drugs targeting blood vessel growth or PD-1/L1/L2.I stopped a T-cell therapy due to severe side effects, but it wasn't for PD-1, PD-L1, or PD-L2.I do not have a severe, uncontrolled infection.My cancer in the treated area has grown significantly.I can take care of myself and am up and about more than half of my waking hours.I have not received a live vaccine in the last 30 days, except for COVID-19 vaccines.I haven't had serious heart problems or a stroke in the last year.I haven't needed strong medication for an autoimmune disease, except psoriasis, in the last 2 years.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have had more than one chemotherapy treatment for endometrial cancer, but no more than two platinum-based treatments.My endometrial cancer is confirmed and has gotten worse.I have brain metastases but have completed treatment for it and been stable and off steroids for at least 28 days.Side effects from my past cancer treatments are mild or gone, except for hair loss, mild anemia, or some nerve pain.I have a severe fistula.I have previously received immunotherapy for my condition.I have a tumor or lymph node large enough to be measured by CT or MRI.I haven't had cancer treatment in the last 28 days.I have had a solid organ or bone marrow transplant.My cancer is microsatellite stable.My cancer has spread to major blood vessels.My heart's pumping ability is below normal.My brain metastases are not stable.I had radiation therapy more than 21 days ago, except for bone lesion treatment.I am not postmenopausal or without a uterus and have a recent negative pregnancy test.I haven't had cancer, except for skin cancer or in situ cancer, in the last 2 years.I haven't taken steroids or immunosuppressants in the last 7 days, except for low-dose prednisone.I have either received, am not eligible for, or have declined platinum-based chemotherapy.I agree to use birth control during and for 4 months after my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab & Lenvatinib
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Does this trial currently have openings for participants?
"Affirmative. Per the information on clinicaltrials.gov, this medical trial is currently in search of prospective participants and was initially posted on April 1st 2022 before being renewed on April 5th 2022. A total of 100 patients are needed from a single location."
Answered by AI
Has the FDA sanctioned Lenvatinib for clinical use?
"Lenvatinib's safety ratings is 2; this score has been assigned as Phase 2 trials have provided some data to confirm the drug's safe usage, yet no evidence exists to suggest efficacy."
Answered by AI
What is the current enrollment count for this clinical experiment?
"Affirmative. According to the clinicaltrials.gov website, this medical trial is currently recruiting patients who first registered on April 1st 2022 and the project has recently been updated as of May 4th 2022. This experiment requires 100 participants and will take place at one site."
Answered by AI
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