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OncoMatch/Clinical Trials/NCT05797831

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Is NCT05797831 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Navtemadlin for endometrial cancer.

Phase 2/3RecruitingKartos Therapeutics, Inc.NCT05797831Data as of May 2026

Treatment: NavtemadlinThis 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.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Biomarker criteria

Required: TP53 wild-type

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

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 →

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