OncoMatch/Clinical Trials/NCT05603910
Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma
Is NCT05603910 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Lenvatinib and Pembrolizumab for recurrent endometrial carcinoma.
Treatment: Lenvatinib · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Endometrial Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Patients must have pMMR tumor subtype(s).
Excluded: MLH1 loss
Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
Excluded: MSH2 loss
Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
Excluded: MSH6 loss
Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
Excluded: PMS2 loss
Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
Excluded: MLH1 loss
Patients with dMMR and uterine carcinosarcomas.
Excluded: MSH2 loss
Patients with dMMR and uterine carcinosarcomas.
Excluded: MSH6 loss
Patients with dMMR and uterine carcinosarcomas.
Excluded: PMS2 loss
Patients with dMMR and uterine carcinosarcomas.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: external beam radiation therapy to the vagina, pelvis, and/or abdomen
Lab requirements
Blood counts
ANC ≥1,500 cells/mm³; Platelets ≥100,000 cells/mm³; Hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min or measured/calculated GFR per institutional standard
Liver function
Serum total bilirubin <1.0 ULN; AST and ALT ≤ 2.5 x ULN or 5 X ULN for patients with liver metastases; Albumin ≥2.5 mg/dL
Patients must have normal organ and marrow function as defined below: 1. Absolute neutrophil count (ANC) ≥1,500 cells/mm³ 2. Platelets ≥100,000 cells/mm³ 3. Hemoglobin ≥9.0 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatine clearance (CrCl) ≥ 40 mL/min or Measured or calculated a creatinine clearance glomerular filtration rate (GFR) can also be used in place of creatinine 5. Serum total bilirubin <1.0 ULN 6. 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 patients with liver metastases 7. Albumin ≥2.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05603910 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior external beam radiation therapy to the vagina, pelvis, and/or abdomen disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
Are patients with MLH1 alterations eligible?
No. MLH1 loss is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 loss is an exclusion criterion.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages