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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab + Radiation for Endometrial Cancer
Phase 1
Recruiting
Led By Matthew Schlumbrecht, MD, MPH
Research Sponsored by Aaron Wolfson
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 1 year
Awards & highlights
Study Summary
This trial tests combining drugs and radiation to stop cancer from spreading.
Who is the study for?
This trial is for women aged 18 or older with recurrent or unresectable endometrial carcinoma that's not mismatch repair deficient. They must have a specific performance status, normal organ and marrow function, no recent investigational drug use, and agree to contraception if of childbearing potential. Exclusions include certain prior treatments, uncontrolled conditions like hypertension or infections (HIV/HBV/HCV), active CNS metastases, other progressing cancers, major surgery recovery, and immunosuppressive therapy within 21 days before the study.Check my eligibility
What is being tested?
The trial tests combining pembrolizumab (an immune checkpoint inhibitor) with lenvatinib (a targeted therapy) alongside a shortened course of pelvic radiation therapy in patients with endometrial cancer. The goal is to determine if this combination can prevent cancer cells from multiplying and spreading.See study design
What are the potential side effects?
Potential side effects may include high blood pressure due to lenvatinib; fatigue, skin reactions, or autoimmune-like symptoms from pembrolizumab; and typical radiation-associated discomfort such as localized skin irritation.
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
Number of Events of Treatment-Related Toxicity
Recommended Phase 2 Dose (RP2D) of Lenvatinib
Secondary outcome measures
Number of Reported Adverse Events
Overall Response Rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) GroupExperimental Treatment3 Interventions
Participants in this group will receive a combination treatment of Lenvatinib, Pembrolizumab, and Hypofx Pelvic EBRT over a period of approximately 10 to 12 weeks.
Lenvatinib - administered in a 3 plus 3 escalation/de-escalation design. Participants will receive 1 of 4 of the following dose levels:
Dose level 1- 4 mg Dose level 2- 8 mg Dose level 3 (Starting dose) - 12 mg Dose level 4- 16 mg
Pembrolizumab- 200 mg IV will be administered on Day 1, 22 and 43
HypoFx whole pelvic EBRT begins on Day 22 and continues for a total of 16 fractions of radiation given at a dose of 2.5 Gy per fraction for a total dose of 40.0 Gy delivered to the pelvis. A pelvic boost HypoFx EBRT consisting of 7 fractions of radiation given at a dose of 2.5 Gy per fraction that will be delivered to site(s) of gross disease of at least 1.0 cm in size. An additional boost total dose of 17.5 Gy administered will be administered over a period of 1.5 to 2.0 weeks.
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?
Aaron WolfsonLead Sponsor
Matthew SchlumbrechtLead Sponsor
Matthew Schlumbrecht, MD, MPHPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is getting worse or needs treatment.My blood tests for organ and bone marrow function are normal.I am scheduled for internal radiation therapy as part of my pelvic treatment.I am still recovering from a major surgery.I am a woman aged 18 or older.I do not have any serious, uncontrolled medical conditions.My endometrial cancer is mismatch repair deficient.I have not received a live vaccine in the last 30 days.My uterine cancer is mismatch repair deficient.I have active brain metastases or carcinomatous meningitis.I haven't taken steroids or immunosuppressants in the last 21 days.My cancer is one of the specified types, confirmed by a biopsy.I am currently receiving another type of biological therapy.I have an active tuberculosis infection.My tumor is of the pMMR subtype.I have a lung condition not caused by an infection.I am unable to make my own medical decisions.I do not have uncontrolled HIV, hepatitis B, or active hepatitis C.My endometrial cancer has returned or can't be removed by surgery, and radiation is considered suitable for me.I have a tumor in my pelvis or vagina that is at least 1 cm large, with no cancer spread outside the pelvis.I am mostly active and can care for myself despite my illness.I am using two birth control methods, am surgically sterile, or not having heterosexual sex.I have previously been treated with drugs like lenvatinib or immunotherapies.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) Group
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.
Has the government sanctioned Lenvatinib, Pembrolizumab and Hypofx EBRT as a feasible medical treatment?
"Due to the limited amount of data confirming efficacy and safety, our team has judged Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) Group on a 1-3 scale as a 1."
Answered by AI
Are there still enrollees being incorporated into this research project?
"Clinicaltrials.gov data indicates that this medical study, which was initially posted on February 1st 2023, is not currently seeking patients. Unfortunately, enrolment for the trial has been suspended; however 3467 other trials are still actively recruiting individuals."
Answered by AI
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