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New treatment option for Recurrent Endometrial Carcinoma
Official title Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma
ClinicalTrials.gov ID: NCT05603910
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent endometrial carcinoma.
Also referred to as Lenvima.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other body sites.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Biopsy-proven recurrent pMMR EC following surgery alone or de novo unresectable pMMR EC for whom External beam radiation therapy (EBRT) has been...
- Measurable disease of at least 1.0 cm in size defined by RECIST 1.1 on imaging studies with at least one (1) site located in the pelvis and/or vagina...
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky score ≥50).
- Patients must have pMMR tumor subtype(s).
- Patients must have normal organ and marrow function as defined below:
You likely can't join if
- Patients who are currently in or have participated in a study of an investigational agent or used an investigational device within 4 weeks of the...
- Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
- Patients with dMMR and uterine carcinosarcomas.
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. EXCEPTION: Patients with previously treated brain...
- Patients with a known additional malignancy that is progressing or requires active treatment. EXCEPTIONS include basal cell carcinoma of the skin...
- Prior treatment with lenvatinib, anti-programmed cell death-1(PD)-1, anti-PD-L1, or any other antibody or drug specifically targeting T-cell...
See the full eligibility criteria
Who can join
- Biopsy-proven recurrent pMMR EC following surgery alone or de novo unresectable pMMR EC for whom External beam radiation therapy (EBRT) has been determined as an appropriate therapeutic approach. Eligible tumor...
- Measurable disease of at least 1.0 cm in size defined by RECIST 1.1 on imaging studies with at least one (1) site located in the pelvis and/or vagina without any foci of extra-pelvic disease (including the para-aortic...
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky score ≥50).
- Patients must have pMMR tumor subtype(s).
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1,500 cells/mm³
- Platelets ≥100,000 cells/mm³
- Hemoglobin ≥9.0 g/dL
- Serum creatinine or Measured or calculated a creatinine clearance glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl) ≤ 1.5 x upper limit of normal (ULN) or CrCl ≥ 40...
- Serum total bilirubin \<1.0 ULN
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) Aminotransferase (AST and ALT) ≤ 2.5 x ULN or 5 X ULN for...
- Albumin ≥2.5 mg/dL CrCl should be calculated per institutional standard.
- Female participants of childbearing potential (those who have not been surgically sterilized or have not been without menses for \>1 year) should be willing to use 2 methods of birth control at the same time or be...
- Ability to understand and the willingness to sign a written informed consent document.
- Women age ≥18 years old.
What rules you out
- Patients who are currently in or have participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study treatment.
- Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
- Patients with dMMR and uterine carcinosarcomas.
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. EXCEPTION: Patients with previously treated brain metastases, including receiving prior brain irradiation, may...
- Patients with a known additional malignancy that is progressing or requires active treatment. EXCEPTIONS include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has...
- Prior treatment with lenvatinib, anti-programmed cell death-1(PD)-1, anti-PD-L1, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Patients who are planned to receive vaginal brachytherapy as their pelvic boost course of radiation as determined by their treating physician(s).
- No prior radiation therapy to the vagina, pelvis, or abdomen will be allowed.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other serious medical condition or social situations that in the...
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of study treatment. Note: Patients with active autoimmune disease that has required systemic...
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Evidence of uncontrolled hypertension as documented in the patient's medical record.
- Known psychiatric illness/condition or substance abuse disorders that in the judgement of the Investigator(s) would interfere with cooperation with requirements of the study.
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.
- Patients with uncontrolled human immunodeficiency virus (HIV) infection, which is defined as follows:
- Antiviral therapy treatment for \<4 weeks AND
- Have an HIV viral load ≥400 copies/mL prior to enrollment.
- Patients with uncontrolled hepatitis B virus (HBV) infection or who are chronic carriers of hepatitis B infection, which is defined as:
- Hepatitis B surface antigen reactive (HbsAg-positive), undetectable or low HBV DNA, and with normal ALT levels who are not on HBV therapy
- Individuals who have serologic evidence of a resolved prior HBV infection (ie, HBSAg-negative and anti-core hepatitis B antibody positive (anti-Hepatitis B core -positive)
- Patients with active, untreated hepatitis C virus (HCV) infection or who have not completed their HCV antiviral regimen. Patients with a history of HCV infection may participate in this study if their HCV ribonucleic...
- Received live vaccine within 30 days prior to the first dose of study treatment.
- Patient has active Mycobacterium tuberculosis infection (tuberculosis or TB).
- A QT interval corrected for heart rate using Bazett's formula (QTcB) ≥ 480msec.
- Patient receiving concurrent additional biologic therapy.
- Patients with impaired decision-making capacity.
- Patients who have not recovered from major surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.