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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Pancreatic Cancer
Phase 1
Waitlist Available
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 up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
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.
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.
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
3,066 Previous Clinical Trials
1,802,231 Total Patients Enrolled
STRATEGIC ALLIANCE: MerckUNKNOWN
Brandon Smaglo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
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.
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