Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer (NCT07763496) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer
France63 participantsStarted 2026-10
Plain-language summary
This phase II study will evaluate the efficacy and safety of relacorilant in combination with nab-paclitaxel in participants with recurrent or metastatic cervical cancer who have previously received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, if eligible.
STELLA is a prospective, open-label, single-arm study. Approximately 63 participants will receive relacorilant orally in combination with intravenous nab-paclitaxel in 28-day treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
The primary objective of the study is to evaluate the objective response rate, defined as the proportion of participants with a complete or partial response as their best overall response according to RECIST version 1.1. Secondary objectives include evaluating duration of response, progression-free survival, overall survival, and the safety and tolerability of the combination.
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:
* Histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
* Recurrent or metastatic cervical cancer:
* Has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy, with or without bevacizumab. Prior chemoradiotherapy in the Locally Advanced Cervical Cancer (LACC) setting is not considered a line of treatment.
* Has received anti-PD-1/anti-PD-L1 therapy as part of a prior cervical cancer treatment regimen, if eligible.
* Has received no more than 3 prior systemic regimens for advanced disease, with no more than one line of single-agent chemotherapy, and/or no more than one antibody-drug conjugate (ADC) therapy.
* Has received no prior treatment with weekly paclitaxel, other than a front-line combination treatment as part of a platinum doublet regimen.
* Has measurable disease per RECIST v1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been demonstrated in such lesions.
* Has provided documented informed consent.
* Is assigned female sex at birth and is at least 18 years of age at the time of providing informed consent.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before inclusion.
* Has consented to provide available formalin-fixed paraffin-embedded (FFPE) tumor tissue from a core/excisional biopsy or surgical re…
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
1
Objective Response Rate (ORR) According to RECIST v1.1
Timeframe: From the date of first study treatment until documented disease progression, assessed up to 48 months.