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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Neuroendocrine Cancer
Phase 2
Recruiting
Led By Emily Bergsland, MD
Research Sponsored by University of California, San Francisco
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 27 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is researching a newly described class of tumors that can occur de novo or over time, and will use special imaging to measure their impact on the body.
Who is the study for?
This trial is for adults with well-differentiated grade 3 neuroendocrine tumors (WD G3 NET), including those in the pancreas, gastrointestinal tract, or lungs with specific characteristics. Participants must have a life expectancy over 3 months and at least one measurable lesion. They should be able to undergo MRI imaging if at UCSF, have good organ function, controlled blood pressure, and agree to use contraception.
What is being tested?
The study tests Lenvatinib combined with Pembrolizumab on patients with WD G3 NETs. It's a Phase II trial across multiple sites without selection based on biomarkers. The effects of treatment are monitored through blood samples, tumor biopsies, and Hyperpolarized 13C-Pyruvate MRI scans that measure changes in the tumor environment.
What are the potential side effects?
Possible side effects include allergic reactions to Lenvatinib or Pembrolizumab; risks of bleeding; high blood pressure; wound healing complications; increased risk of infections due to immunosuppression; potential psychiatric disturbances from medication interactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Median Progression-Free Survival
Median Progression-Free Survival at 18 weeks
Median duration of response
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lenvatinib Plus PembrolizumabExperimental Treatment3 Interventions
Participants will receive 20 mg once daily of lenvatinib plus 400 mg of pembrolizumab every 6 weeks for up to 18 doses. Eligible participants may also receive a Hyperpolarized 13C-pyruvate (HP 13C) magnetic resonance imaging (MRI) scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2017
Completed Phase 4
~2070
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,147 Total Patients Enrolled
4 Trials studying Neuroendocrine Tumors
653 Patients Enrolled for Neuroendocrine Tumors
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,304 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
2,163 Patients Enrolled for Neuroendocrine Tumors
Emily Bergsland, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
336 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
300 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had coughing up blood or tumor bleeding in the last 3 weeks.I don't have any health issues that could affect the study's results.My cancer progressed after treatment and my Ki67 score is below 30%.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.My cancer is a specific type of neuroendocrine tumor.I have an immune system disorder or am on long-term steroids.I have a history of hepatitis B or an active hepatitis C infection.I have an active tuberculosis infection.I have at least two tumors larger than 1 cm; one can be biopsied, and one can be imaged by MRI.My cancer has worsened in the last 6 months as shown by scans.I have had a serious heart condition in the last year.I have a severe fistula.My organs are working well.I am 18 years old or older.I am fully active or can carry out light work.I have had or currently have lung inflammation treated with steroids.I am currently being treated for an infection.I am not on any treatments or vaccinations banned in the study.I don't have conditions affecting my body's ability to absorb medication.I have been treated for an autoimmune disease in the last 2 years.I agree to have a biopsy of my cancer at the start of the study.I have active brain metastases or cancer in the lining of my brain.My cancer is advanced, cannot be surgically removed, and has a high growth rate.I have been diagnosed with HIV.My blood pressure is not well-controlled.I am allergic or have had a severe reaction to lenvatinib or pembrolizumab.I have a serious wound, ulcer, or bone fracture that is not healing.My scans show cancer has spread to major blood vessels.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib Plus Pembrolizumab
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.
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