Lenvatinib for Recurrent Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Virginia Commonwealth University, Richmond, VARecurrent Endometrial Cancer+2 MoreLenvatinib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Recurrent Endometrial Cancer
  • Endometrial Cancer
  • Mismatch Repair Proficient

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Lenvatinib
1
Carboplatin
1
pembrolizumab

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 30 days (plus or minus 15 days) following last dose of study treatment

24 Weeks
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
Day 30
Determine the number of patients with treatment-related adverse events (AEs) in the study population
Day 90
Determine the median progression free survival (PFS)
Day 30
Determine the number of patients who discontinue treatment due to treatment-related adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Lenvatinib
2
Carboplatin
2
pembrolizumab

Side Effects for

Randomization Phase: Lenvatinib 24 mg
70%Diarrhoea
69%Hypertension
57%Decreased appetite
54%Weight decreased
49%Nausea
44%Fatigue
40%Headache
38%Proteinuria
38%Stomatitis
38%Vomiting
33%Arthralgia
33%Dysphonia
33%Palmar-plantar erythrodysaesthesia syndrome
32%Constipation
30%Cough
26%Asthenia
25%Oedema peripheral
21%Rash
20%Myalgia
20%Back pain
19%Abdominal pain
18%Pain in extremity
18%Dyspnoea
18%Abdominal pain upper
18%Dry mouth
18%Dysgeusia
18%Musculoskeletal pain
17%Dizziness
16%Hypokalaemia
16%Pyrexia
16%Oropharyngeal pain
15%Hypocalcaemia
15%Dyspepsia
14%Epistaxis
13%Alopecia
13%Dysphagia
12%Anaemia
12%Musculoskeletal chest pain
12%Dry skin
11%Nasopharyngitis
11%Urinary tract infection
10%Oral pain
10%Electrocardiogram QT prolonged
10%Thrombocytopenia
10%Hypoalbuminaemia
10%Blood creatinine increased
10%Upper respiratory tract infection
9%Dehydration
9%Neck pain
8%Muscle spasms
8%Muscular weakness
8%Lymphopenia
8%Influenza like illness
8%Hypomagnesaemia
8%Alanine aminotransferase increased
8%Depression
7%Blood thyroid stimulating hormone increased
7%Toothache
7%Bronchitis
7%Ejection fraction decreased
7%Blood alkaline phosphatase increased
7%Aspartate aminotransferase increased
7%Malaise
7%Glossodynia
7%Haematuria
7%Hyponatraemia
7%Pruritus
7%Platelet count decreased
7%Hyperkeratosis
6%Anxiety
6%Influenza
6%Hyperglycaemia
6%Flatulence
6%Leukopenia
6%Dysuria
5%Productive cough
5%Non-cardiac chest pain
5%White blood cell count decreased
5%Paraesthesia
5%Hypothyroidism
5%Pneumonia
5%Haemoptysis
3%General physical health deterioration
2%Lung infection
2%Lower respiratory tract infection
2%Sepsis
2%Spinal cord compression
2%Malignant pleural effusion
2%Cholecystitis
2%Hypotension
2%Pulmonary embolism
2%seizure
2%Acute kidney injury
2%Atrial fibrillation
2%Acute myocardial infarction
1%Coronary artery stenosis
1%Colitis
1%Wound infection
1%Transient ischaemic attack
1%Nephrotic syndrome
1%Respiratory failure
1%Pneumatosis intestinalis
1%Cerebrovascular accident
1%Intracranial tumour haemorrhage
1%Syncope
1%Vocal cord paralysis
1%Uterine prolapse
1%Acute coronary syndrome
1%Gastroenteritis
1%Bone pain
1%Diverticulitis
1%Perineal abscess
1%Hypercalcaemia
1%Acute respiratory failure
1%Malignant neoplasm progression
1%Osteoarthritis
1%Cancer pain
1%Pancreatitis
1%Blood uric acid increased
1%Confusional state
1%Death
1%Hepatic failure
1%Liver injury
1%Appendicitis
1%Bacteraemia
1%Small intestinal obstruction
1%Atrial flutter
1%Intestinal obstruction
1%Cardio-respiratory arrest
1%Monoparesis
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT01321554) in the Randomization Phase: Lenvatinib 24 mg ARM group. Side effects include: Diarrhoea with 70%, Hypertension with 69%, Decreased appetite with 57%, Weight decreased with 54%, Nausea with 49%.

Trial Design

1 Treatment Group

Pembrolizumab & Lenvatinib
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Lenvatinib · No Placebo Group · Phase 2

Pembrolizumab & LenvatinibExperimental Group · 2 Interventions: Lenvatinib, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 3
~3590
Pembrolizumab
2017
Completed Phase 3
~2200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days (plus or minus 15 days) following last dose of study treatment

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
630 Previous Clinical Trials
367,377 Total Patients Enrolled
Leslie Randall, MDPrincipal InvestigatorMassey Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You identify as being mostly Black, including Black, African-American, Black Hispanic (Afro-Latinx), African, or Afro-Caribbean ancestry.
If the area to be treated with radiation has grown significantly since your last scan, it will be considered a target for this study.
You are able to swallow pills or capsules.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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