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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

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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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
Lenvatinib
2020
Completed Phase 4
~2650
Pembrolizumab
2017
Completed Phase 2
~2010

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway to help the immune system recognize and attack cancer cells. Lenvatinib, a tyrosine kinase inhibitor, targets receptors involved in tumor growth and angiogenesis, inhibiting cancer cell proliferation and spread. Pelvic External Beam Radiation Therapy causes DNA damage in cancer cells, leading to cell death and preventing further growth. Understanding these mechanisms helps endometrial cancer patients make informed treatment decisions and comprehend how these therapies target their cancer.
Lenvatinib in Management of Solid Tumors.Second-line lenvatinib in patients with recurrent endometrial cancer.

Find a Location

Who is running the clinical trial?

Aaron WolfsonLead Sponsor
Matthew SchlumbrechtLead Sponsor
Matthew Schlumbrecht, MD, MPHPrincipal InvestigatorUniversity of Miami

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05603910 — Phase 1
Endometrial Cancer Research Study Groups: Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) Group
Endometrial Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT05603910 — Phase 1
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603910 — Phase 1
~6 spots leftby Apr 2025