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Checkpoint Inhibitor
Lenvatinib + Pembrolizumab for Pancreatic Cancer
Phase 2
Recruiting
Led By Vincent Chung
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Age: >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with advanced pancreatic cancer that cannot be removed by surgery. Lenvatinib blocks some of the enzymes needed for cell growth and pembrolizumab helps the body's immune system attack the cancer.
Who is the study for?
Adults with advanced, inoperable pancreatic cancer who've had at least 16 weeks of prior therapy without disease progression. They must have proper liver and kidney function, controlled blood pressure, no recent immunosuppressive treatments or active infections, and not be pregnant or breastfeeding. Participants should agree to use contraception and provide samples for research.Check my eligibility
What is being tested?
The trial is testing the combination of lenvatinib (an enzyme inhibitor) and pembrolizumab (an immunotherapy drug) as maintenance therapy for patients with advanced pancreatic cancer to see if it can stop tumor growth by blocking cell growth enzymes and boosting the immune system's attack on cancer cells.See study design
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, loss of appetite, thyroid issues from lenvatinib; pembrolizumab may cause immune-related reactions affecting organs like lungs or intestines, skin rash, infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
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I am 18 years old or older.
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My diagnosis is advanced pancreatic cancer that cannot be surgically removed.
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I am a woman who can have children and my pregnancy test is negative.
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I have not received treatments targeting immune checkpoints.
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My cancer can be measured or evaluated by specific criteria.
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My hemoglobin level is above 9.0 g/dL without recent blood transfusions.
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My kidney function, measured by creatinine levels, is within the required range.
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I've had initial cancer treatment for over 16 weeks and my disease hasn't worsened.
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My liver enzyme (ALT) levels are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, lenvatinib mesylate)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and lenvatinib mesylate PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,632 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,373 Total Patients Enrolled
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
381 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all pre-disease activities without restriction.You have been diagnosed with HIV in the past.I am 18 years old or older.My diagnosis is advanced pancreatic cancer that cannot be surgically removed.My blood clotting time is normal or managed with medication.My blood pressure is not controlled even with medication.I am not using, nor plan to use, drugs that strongly affect liver enzyme CYP3A4.I have had or currently have lung inflammation treated with steroids.I have an active tuberculosis infection.I don't have active brain metastases and haven't needed steroids for them in the last 14 days.My urine protein levels are low based on a 24-hour test.My last chemotherapy was less than 30 days ago.Your platelet count is at least 100,000 per cubic millimeter within 14 days before the start of the study.I am not taking any dietary or herbal supplements, except for CBD.My blood clotting time is normal or managed if I'm on blood thinners.I am currently being treated for an infection.Your body has enough infection-fighting white blood cells.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I am a woman who can have children and my pregnancy test is negative.I do not have serious heart problems like recent heart attacks or severe heart failure.I have not received treatments targeting immune checkpoints.Your liver function test result must be within a certain range, and if you have cancer that has spread to your liver, the range is a bit higher.I have received an organ or tissue transplant from another person.I have not received a live vaccine in the last 30 days.I am not taking any medications known to affect heart rhythm.I haven't had radiotherapy in the last 2 weeks and have no side effects from it.I am not pregnant or breastfeeding and either cannot become pregnant or will use birth control during the study.I have recovered from side effects of previous treatments, except for mild neuropathy.I have no cancer history except for certain skin cancers, early-stage cancers, or any cancer I've been free from for 2+ years.I have trouble taking pills due to swallowing issues or constant nausea.My cancer has not significantly invaded major blood vessels.Your body's salt and mineral levels are not normal and have not been fixed.My cancer can be measured or evaluated by specific criteria.I agree to use contraception and not donate sperm for 90 days after my last treatment dose.My hemoglobin level is above 9.0 g/dL without recent blood transfusions.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am not taking strong drugs that affect liver enzymes.Your bilirubin levels in your blood need to be within a certain range.My kidney function, measured by creatinine levels, is within the required range.I have a known history of hepatitis B or active hepatitis C.I've had initial cancer treatment for over 16 weeks and my disease hasn't worsened.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My liver enzyme (ALT) levels are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, lenvatinib mesylate)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Has the FDA sanctioned Pembrolizumab for therapeutic use?
"While there is some clinical data supporting the safety of Pembrolizumab, it remains unproven in terms of efficacy. Therefore, it received a score of 2."
Answered by AI
Are participants being sought for this research project?
"The trial, which as of October 7th 2022 is still recruiting patients, was first posted on July 21st 2021."
Answered by AI
What are some of the more common reasons that doctors will prescribe Pembrolizumab?
"Pembrolizumab can be used to fight cancerous growths, unresectable melanomas, and microsatellite instability high."
Answered by AI
How many volunteers are needed for this clinical trial?
"The listing on clinicaltrials.gov does show that the trial is open for recruitment and has been since 7/21/2021. As of 10/7/2022, they are still recruiting the 28 patients needed from 1 location."
Answered by AI
Are there any other Pembrolizumab trials that we can compare this one to?
"Pembrolizumab is being trialed in 1076 active clinical studies, 134 of which have reached Phase 3. The high number of trial locations (37371) reflects Pembrolizumab's widespread use. However, many of these trials are based in Sacramento, California."
Answered by AI
Who else is applying?
What state do they live in?
Idaho
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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