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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the start of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My cancer is confirmed as metastatic melanoma or kidney cancer.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from the start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best brain metastasis response rate (BMRR)
Secondary outcome measures
Best overall objective response rate
Duration of brain metastasis response
Overall Survival (OS)
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,762 Total Patients Enrolled
15 Trials studying Melanoma
741 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,948 Total Patients Enrolled
120 Trials studying Melanoma
21,627 Patients Enrolled for Melanoma
Harriet Kluger, MDPrincipal InvestigatorProfessor of Medicine
5 Previous Clinical Trials
152 Total Patients Enrolled
5 Trials studying Melanoma
152 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.I have symptoms from melanoma or kidney cancer that has spread to my brain.You had a positive pregnancy test within 3 days before the study starts.I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.My cancer has spread to the lining of my brain and spinal cord.I am currently on medication for an infection.I haven't had serious heart problems in the last 6 months.Your heart's electrical activity takes longer than normal to restart after each beat.I haven't taken any cancer treatment or experimental drugs in the last 14 days.Tests show that the cancer has invaded major blood vessels.I have received at least 2 doses of a drug targeting PD-1/PD-L1 in my treatment for melanoma or kidney cancer.You have mental health or drug problems that would make it hard for you to follow the trial's rules.I am not using high doses of steroids for brain symptoms, or I've been on a low dose (≤10 mg prednisone or equivalent) without brain symptoms for over a week.My organs are functioning well.I have bleeding from brain metastases.I have a severe fistula.I have had lung inflammation not caused by infection or radiation that didn't improve with steroids.I have a history of Hepatitis B or currently have Hepatitis C.I agree to follow the study's rules on using birth control and not donate sperm.I have an active autoimmune disease or a history of severe autoimmune disease.My blood pressure is under control.I am 18 or older with melanoma or kidney cancer that has spread to my brain and hasn't been treated.My brain metastasis fits certain size and symptom guidelines.I have not received a live vaccine in the last 30 days.I can provide a tissue sample from my surgery if I had one for cancer.I have an immune system disorder or I'm on long-term steroids.I have a bleeding disorder or a high risk of severe bleeding.I have a serious wound that is not healing.I had brain radiotherapy less than a week before starting the study treatment.I am not using or cannot use birth control.I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.I have a stomach or intestine condition that affects medication absorption.You cannot have an MRI scan.My high blood pressure is not under control.My cancer is confirmed as metastatic melanoma or kidney cancer.I have another cancer that is getting worse or needs treatment.I am fully active or can carry out light work.I have been diagnosed with HIV.You have more than 2 grams of protein in your urine over a 24-hour period.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Melanoma
- Group 2: Cohort 2: Renal Cell Carcinoma
Awards:
This trial has 1 awards, including:- 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.
Is recruitment for this clinical trial still available?
"This clinical trial is actively seeking participants. It was first launched on February 9th 2022, and the latest update was published on September 26th 2022."
Answered by AI
Has the Food and Drug Administration given a green light to Pembrolizumab?
"Pembrolizumab achieved a safety score of 2, as only preliminary data has been collected on its efficacy. Nonetheless, the available information indicates that it is safe to use."
Answered by AI
How many participants are currently enrolled in this experiment?
"Indeed, the records on clinicaltrials.gov signal that this scientific trial is actively recruiting individuals. This research project was first posted on February 9th 2022 and recently updated on September 26th 2022, with a target of 56 patients from one location."
Answered by AI
Could you explain what health conditions have been identified as responsive to pembrolizumab?
"Pembrolizumab is regularly used to ameliorate malignant neoplasms, and has shown effectiveness in treating unresectable melanoma, microsatellite instability high cases, as well as conditions that have developed after chemotherapy."
Answered by AI
What other research efforts have been made to explore the therapeutic applications of Pembrolizumab?
"Currently, there are 134 Phase 3 trials and 1032 total studies investigating the efficacy of Pembrolizumab. Notably, Sacramento, California is hosting several clinical trial sites but in totality 37065 locations across the world has opened their doors for these experiments."
Answered by AI
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