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Navtemadlin as Maintenance Therapy for Endometrial Cancer

This study is testing an experimental oral drug called navtemadlin as a maintenance treatment for advanced or recurrent endometrial cancer. You may be able to join if you are a woman aged 18 or older, have endometrial cancer that is TP53WT (a specific genetic marker), and have completed chemotherapy with a good response (complete or partial response). The study aims to see if navtemadlin can help prevent the cancer from growing or returning for a longer time compared to a placebo (an inactive pill that looks the same). The study is currently unclear on its recruitment status and plans to enroll 268 participants.

Study design
This interventional study has two parts. Part 1 will compare two doses of navtemadlin to an observational control, and Part 2 will compare the chosen navtemadlin dose to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants live without their cancer progressing for up to 50 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05797831

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Kartos Therapeutics, Inc.
~268 participants
Updated 2024-05-02 on ClinicalTrials.gov
What's tested:NavtemadlinNavtemadlin Placebo

At a glance

Recruiting sites
83 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: To determine the navtemadlin Phase 3 dose
Measured over 12 months
+1 more outcome measured

Conditions

Endometrial Cancer

Explore related trials

Endometrial Carcinoma

Where it's being run

83 sites across 29 states
Italy13
Poland9
Spain9
Romania7
Georgia5
Texas3
Austria3
Israel3

Who to contact

John Mei
[email protected]
650-542-0136
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
Indwelling surgical drains
Grade 2 or higher QTc prolongation
History of major organ transplant
History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

What this trial measures

  • Part 1: To determine the navtemadlin Phase 3 dose12 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 placebo50 months

    PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first