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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Pancreatic Cancer
Phase 1
Recruiting
Led By Brandon Smaglo, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will study if a combination of two drugs can help control pancreatic cancer.
Who is the study for?
This trial is for adults with advanced pancreatic ductal adenocarcinoma who've had one prior treatment for metastatic disease. They must be able to consent, have controlled blood pressure, a life expectancy over 3 months, adequate organ function, and can swallow pills. Excluded are those with certain serious health issues like fluid accumulation needing drainage or active infections, brain metastases, recent major surgery or therapy that could affect the trial's outcome.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with lenvatinib in controlling advanced pancreatic cancer after first-line treatment failure. Participants will provide tissue samples from their tumors and undergo imaging based on RECIST 1.1 criteria to measure the effects of these drugs.See study design
What are the potential side effects?
Potential side effects include high blood pressure managed by medication; however specific side effects of pembrolizumab and lenvatinib aren't listed but may involve immune-related reactions due to pembrolizumab's nature as an immunotherapy drug and various common drug-related adverse events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To obtain a preliminary estimate of the ORR* of the combination of pembrolizumab and lenvatinib in patients with advanced pancreatic ductal adenocarcinoma
Side 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: PembrolizumabExperimental Treatment2 Interventions
by vein over about 30 minutes on Day 1 of each cycle.
Group II: LenvatinibExperimental Treatment2 Interventions
2 lenvatinib capsules at the same time by mouth every day while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,306 Total Patients Enrolled
92 Trials studying Adenocarcinoma
10,353 Patients Enrolled for Adenocarcinoma
STRATEGIC ALLIANCE: MerckUNKNOWN
Brandon Smaglo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Adenocarcinoma
15 Patients Enrolled for Adenocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 2 weeks or still have side effects.I have had significant coughing up of blood or tumor bleeding in the last 2 weeks.My blood pressure is ≤150/90 mm Hg and stable for the last week.I have had or currently have lung inflammation treated with steroids.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My pancreatic tumor is not adenocarcinoma.My pancreatic cancer diagnosis is confirmed by lab tests.I have a history of HIV, hepatitis B, or hepatitis C.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I have previously been treated with specific medications.I have not received a live vaccine within the last 30 days.I have had an organ or bone marrow transplant.I have a stomach or intestine condition that affects how my body absorbs medication.I am currently being treated for an infection.I have fluid buildup needing drainage or medication in the last 2 weeks.I was diagnosed with another cancer besides the one being treated in this study within the last year.I don't have any health issues that could affect this study's results.My cancer has spread to my brain or spinal cord.My organ functions are within the required range for the study.I am a man and agree to use contraception if I am taking lenvatinib.I am using birth control as required if I can have children.My cancer can be measured and has grown in areas previously treated with radiation.I had a blood clot in an artery in the last year.I agree to provide a recent or archived tumor tissue sample for the study.I have had serious heart problems in the last year.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has worsened after my first treatment.I have had at least one treatment for my cancer after it spread.I am at least 18 years old.My scans show cancer has grown into or around a major blood vessel.I have a preexisting abnormal connection between two body parts.I have an autoimmune disease treated with medication in the last 2 years.I can swallow and keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib
- Group 2: Pembrolizumab
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
Are there any available openings for this research initiative at the moment?
"Clinicaltrials.gov suggests that this clinical trial is actively seeking candidates, with the initial posting date being August 31st 2022 and most recent update on October 13th 2022."
Answered by AI
What is the enrolment rate for this trial?
"Indeed, the records stored on clinicaltrials.gov demonstrate that this research project is presently enrolling participants. It was originally posted on August 31st 2022 and subsequently altered October 13th of the same year. This medical trial seeks to engage 15 patients at a solitary location."
Answered by AI
Has Pembrolizumab attained regulatory clearance from the FDA?
"Due to the early stage of development, there is only limited data confirming Pembrolizumab's safety and efficacy. As such, it earned a score of 1 on our rating scale."
Answered by AI
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