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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Skin and Kidney Cancers with Brain Metastases

Phase 2
Recruiting
Led By Harriet Kluger, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment for melanoma or RCC cohorts must include at least 2 doses of an anti-PD-1/PD-L1 drug at some point in their treatment course
Male/female participants who are at least 18 years of age with histologically confirmed diagnosis of melanoma or RCC and untreated metastatic brain disease
Must not have
Symptomatic melanoma or RCC brain metastases at the time of therapy initiation
New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the start of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is for cancer patients with brain metastases who have not yet been treated for them. There are two groups of patients, those with melanoma and those with renal cell carcinoma.

Who is the study for?
Adults with melanoma or renal cell carcinoma (RCC) and untreated brain metastases who've had at least two doses of anti-PD-1/PD-L1 drugs. They must not be pregnant, agree to contraception, have a life expectancy over 3 months, stable blood pressure, good organ function, and an ECOG status of 0-1. Exclusions include symptomatic brain metastases, recent cancer treatments or vaccines, serious infections or bleeding risks.
What is being tested?
The trial is testing Pembrolizumab combined with Lenvatinib in patients who have previously received PD-1/PD-L1 inhibitors but now have untreated brain metastases from either melanoma or RCC. It's a phase 2 study designed to evaluate the effectiveness and safety of this combination therapy.
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs like the liver or lungs, high blood pressure due to Lenvatinib, fatigue from Pembrolizumab; both drugs can also increase the risk of infection and cause digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received at least 2 doses of a drug targeting PD-1/PD-L1 in my treatment for melanoma or kidney cancer.
Select...
I am 18 or older with melanoma or kidney cancer that has spread to my brain and hasn't been treated.
Select...
I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.
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My cancer is confirmed as metastatic melanoma or kidney cancer.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have symptoms from melanoma or kidney cancer that has spread to my brain.
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I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.
Select...
My cancer has spread to the lining of my brain and spinal cord.
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I am currently on medication for an infection.
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I have bleeding from brain metastases.
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I have a severe fistula.
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I have had lung inflammation not caused by infection or radiation that didn't improve with steroids.
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I have a history of Hepatitis B or currently have Hepatitis C.
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I have an active autoimmune disease or a history of severe autoimmune disease.
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I have an immune system disorder or I'm on long-term steroids.
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I have a bleeding disorder or a high risk of severe bleeding.
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I have a serious wound that is not healing.
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I had brain radiotherapy less than a week before starting the study treatment.
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I am not using or cannot use birth control.
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I have a stomach or intestine condition that affects medication absorption.
Select...
My high blood pressure is not under control.
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I have another cancer that is getting worse or needs treatment.
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I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best brain metastasis response rate (BMRR)
Secondary study objectives
Best overall objective response rate
Duration of brain metastasis response
Overall Survival (OS)
+1 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.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Renal Cell CarcinomaExperimental Treatment2 Interventions
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Group II: Cohort 1: MelanomaExperimental Treatment2 Interventions
Participants who are melanoma (PD-1/PD-L1-experienced)
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?

Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,040,349 Total Patients Enrolled
15 Trials studying Melanoma
720 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,185,344 Total Patients Enrolled
123 Trials studying Melanoma
22,106 Patients Enrolled for Melanoma
Harriet Kluger, MDPrincipal InvestigatorProfessor of Medicine
6 Previous Clinical Trials
238 Total Patients Enrolled
5 Trials studying Melanoma
142 Patients Enrolled for Melanoma

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04955743 — Phase 2
Melanoma Research Study Groups: Cohort 1: Melanoma, Cohort 2: Renal Cell Carcinoma
Melanoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04955743 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04955743 — Phase 2
~25 spots leftby Jan 2027
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