Navtemadlin as Maintenance Treatment for Endometrial Cancer After Chemotherapy
Tests navtemadlin maintenance therapy in adults with advanced or recurrent endometrial cancer.
Plain-language title generated from the registry record
Registry title: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Key facts
- Where
- A Coruña, Barcelona, Galdakao, Jaén, Jerez de la Frontera, Las Palmas, León, Santiago de Compostela, and Seville, SpainSee the 9 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with advanced or recurrent endometrial cancer whose tumor is TP53WT and who responded to chemotherapy. Navtemadlin is tested as maintenance treatment after chemotherapy.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Advanced or recurrent endometrial cancer, confirmed by tissue or cell tests. ECOG 0-1.
- Earlier treatment
- Must have finished one line of up to 6 cycles of taxane-platinum chemotherapy with a complete or partial response per RECIST V1.1. Cannot have had immune therapy, cytokine therapy or any investigational therapy within 28 days.
- Biomarker or test result
- Tumor documented as TP53WT. Blood, liver and kidney function must be adequate (within 14 days).
Main reasons for not taking part
- Any sarcomas or small-cell carcinomas with neuroendocrine differentiation
- Indwelling surgical drains
- Grade 2 or higher QTc prolongation
- History of major organ transplant
- History of bleeding disorder, or major or intracranial bleeding within 24 weeks
Read by machine on 12 November 2026.
Where in Spain
- CHUAC (Hospital de Coruña)A Coruña, SpainContact: John MeiTaking people
- Hospital del MarBarcelona, SpainContact: John MeiTaking people
- Hospital Galdakao-UsansoloGaldakao, SpainContact: John MeiTaking people
- Hospital Universitario de JaénJaén, SpainContact: John MeiTaking people
- H.G.U. Jerez de la FronteraJerez de la Frontera, SpainContact: John MeiTaking people
- Hospital U Insular de GCLas Palmas, SpainContact: John MeiTaking people
- Hospital de LeónLeón, SpainContact: John MeiTaking people
- HCU Santiago de CompostelaSantiago de Compostela, SpainContact: John MeiTaking people
- Hospital Universitario de ValmeSeville, SpainContact: John MeiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kartos Therapeutics, Inc.
- Trial code
- NCT05797831
- Record updated
- 2 May 2024
- Original 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.Read full original descriptionShow less
A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
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.
Inclusion: ECOG 0-1; Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT; Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1; Adequate hematologic, hepatic and renal function (within 14 days).
Exclusion: Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days); Indwelling surgical drains; History of major organ transplant; History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks); Grade 2 or higher QTc prolongation; Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation.