OncoMatch/Clinical Trials/NCT05797831
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Is NCT05797831 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies Navtemadlin for endometrial cancer.
Treatment: Navtemadlin — This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Endometrial Cancer
Biomarker criteria
Required: TP53 wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: taxane-platinum based chemotherapy — first-line
completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
Cannot have received: immune therapy
Prior immune therapy (within 28 days)
Cannot have received: cytokine therapy
Prior cytokine therapy (within 28 days)
Cannot have received: investigational therapy
Prior investigational therapy (within 28 days)
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Kaiser Permanente Center · Vallejo, California
- Northside Hospital · Atlanta, Georgia
- St. Joseph · Savannah, Georgia
- Dr. Sudarshan K. Sharma, Ltd. · Hinsdale, Illinois
- Parkview Research Center · Fort Wayne, Indiana
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05797831 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune therapy, cytokine therapy, investigational therapy disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
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