Status:
Recruiting
Disease Site:
Endometrial
Phase:
Official Title:
GOG-3089 (KRT-232-118) A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53 WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
NCT ID:
NCT#05797831
Link to Full Details:
Description:
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:
Female – 18 years and older
Inclusion Criteria:
- Advanced or Recurrent disease (FIRST RELAPSE) must have completed a single line of up to 6 cycles of taxane-platinum chemo (NOT including adjuvant/neoadjuvant chemo) and achieved a CR/PR per RECIST 1.1
- Primary Stage IV Disease:
- Had a primary or later debulking surgery during first-line platinum tx with RO resection OR
- Had a primary or later debulking surgery during first-line taxane-platinum tx with R1 resection OR
- Had no surgery
- Subjects at First Relapse (relapse after primary therapy including surgery and/or chemo with/without immunotherapy for Stage I-IV disease):
- Has Stage I-III disease at diagnosis and received adjuvant chemo with/without immunotherapy at initial diagnosis and relapsed later OR
- Has Stage I-III disease at diagnosis and did not received adjuvant chemo with/without immunotherapy at initial diagnosis and relapsed later OR
- Had Stage IV disease at diagnosis and initially received immunotherapy or endocrine therapy with/without surgery and relapsed later
- Must be able to initiate study treatment within 6 weeks after completion of their final dose of chemo