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

Condition(s) studied

Investigational drug(s) / intervention(s)

Navtemadlin: Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

Navtemadlin Placebo: Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Study summary

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.

Eligibility

Primary outcome measure(s)

• Part 1: To determine the navtemadlin Phase 3 dose — 12 months
  Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
• Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo — 50 months
  PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first

Trial sites (83)

+ 43 more sites — see the full list on the official registry below.

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