WithdrawnPhase 1/2

AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer

Stopped: Molecule not available from the laboratory

0Started 2025-10-15

Plain-language summary

The aim of this study is to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of bemarituzimab given in combination with a fixed dose of bevacizumab and to assess the clinical activity of the proposed combination bemarituzumab and bevacizumab in 3 parallel and independent cohorts of gynecological cancer (endometrium, ovary and cervix).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: I1. Female patients ≥ 18 years of age at time of ICF signature. I2. Patients must have histologically or cytologically confirmed locally advanced or metastatic gynaecological cancer including * Cohort I - all endometrial carcinoma (endometroid, serous, carcinosarcoma and undifferentiated or clear cell carcinoma). Uterine neuroendocrine carcinoma and uterine sarcoma are not eligible. * Cohort II - high grade ovarian cancer patients (endometrioid, serous, clear cell, carcinosarcoma), platinum resistant. Note 1: Patients who have only had 1 prior line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission \[CR\] or partial response/remission \[PR\]) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum; patients who have received 2 or 3 prior lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum; patients allergic to platinum and unable to reintroduce platinum despite a desensitisation technique are eligible. Beyond 3 prior lines, no specific requirements about PD on platinum. Note 2: Platinum-Resistant Ovarian Cancer (PROC) with high folate receptor-alpha expression should have received mirvetuximab soravtansine if reimbursed before to be included. * Cohort III - squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix. I3. Previously treated by at least…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose escalation part : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Timeframe: 6 weeks

Extension part : Progression free rate (PFR)

Timeframe: 12 weeks

Trial details

NCT IDNCT07146919

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10-15

View on ClinicalTrials.gov More Endometrial Carcinoma trials