Recurrent or Metastatic Cervical CancerPhase 2STELLANCT07763496
Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing Relacorilant and Nab-paclitaxel in people with Recurrent or Metastatic Cervical Cancer, run by ARCAGY/ GINECO GROUP at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent or Metastatic Cervical Cancer
- What is being tested?
- Relacorilant and Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 29Show fewer
- 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 resection specimen. If unavailable, the most representative FFPE tumor block of the disease should be provided.
- Adverse events due to previous anticancer therapies must have recovered to Grade ≤1 or baseline, except alopecia or vitiligo. Participants with endocrine-related adverse events who are adequately treated with hormone replacement therapy are eligible.
- Participants with HIV infection must have well-controlled HIV on antiretroviral therapy (ART), defined as:
- CD4+ T-cell count ≥350 cells/mm³ at screening.
- Confirmed HIV RNA below 50 copies/mL or below the lower limit of quantification for at least 12 weeks before screening.
- No AIDS-defining opportunistic infection within the previous 12 months.
- Stable ART regimen without changes in drugs or dose modification for at least 4 weeks before inclusion, with agreement to continue ART throughout the study. The ART regimen must not contain strong CYP3A4 inducers or CYP3A substrates that cannot be dose-adjusted when coadministered with strong CYP3A inhibitors.
- Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to inclusion.
- Has adequate organ function:
- Absolute neutrophil count ≥1,500 cells/mm³ without G-CSF support within 2 weeks before screening laboratory sample collection.
- Platelet count ≥100,000/mm³ without transfusion within 2 weeks before screening laboratory sample collection.
- Hemoglobin ≥9 g/dL without transfusion within 2 weeks before screening laboratory sample collection.
- AST and ALT ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in the presence of liver metastases.
- Total bilirubin ≤1.5 × ULN, or ≤3 × ULN for participants with Gilbert's syndrome.
- Albumin ≥2.5 g/dL.
- Calculated creatinine clearance ≥30 mL/min, with full recovery from any episode of acute renal failure.
- Participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception; hormonal contraceptives are not allowed.
- Is affiliated with a social insurance regimen.
- Is willing and able to comply with the protocol for the duration of the study, including treatment, scheduled visits, examinations, and follow-up.
Who cannot join
- Grade ≥2 peripheral neuropathy.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Clinically relevant and reversible toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to Grade ≤1 before enrollment, except alopecia, hearing loss, vitiligo, and endocrinopathy managed with replacement therapy.
- Surgery within 4 weeks prior to enrollment or anticipated requirement for a surgical procedure during the study. Participants must have adequately recovered from toxicity and/or complications of prior major surgery.
- Has received any of the following before enrollment:
- Chemotherapy, immunotherapy, investigational agent, or other treatment for the disease under study within 5 half-lives of the prior therapy, or 28 days if 5 half-lives is longer than 28 days, before the first dose of study treatment.
Show all 30Show fewer
- Radiotherapy not completed at least 2 weeks before the first dose of study treatment.
- Systemic, inhaled, or prescription-strength topical corticosteroids within a period equivalent to 5 half-lives of the corticosteroid before the first dose.
- Wide-field radiation therapy to more than 25% of marrow-bearing areas.
- Requires chronic or frequently used systemic corticosteroids for medical conditions or illnesses.
- History of severe hypersensitivity or severe reaction to any study treatment.
- Has received prior treatment with mifepristone or another glucocorticoid receptor modulator as part of a treatment regimen for cervical cancer.
- Is pregnant, breastfeeding, or planning to conceive during the projected duration of the study through at least 6 months after the last dose of study treatment.
- Has clinically significant uncontrolled condition(s) that, in the investigator's opinion, may confound study results or interfere with participant safety or participation, including but not limited to:
- Unstable angina.
- Myocardial infarction within 6 months before the first dose.
- New York Heart Association Class II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication or prolongation of QTcF.
- Severe or advancing cirrhosis.
- Active infectious disease requiring intravenous therapy within 2 weeks before the first dose.
- Gastric-outlet obstruction.
- Acute renal failure that has not recovered to baseline renal function.
- Known psychiatric disorder that would interfere with study compliance.
- Current uncontrolled chronic or acute infection with HIV, hepatitis C virus, or hepatitis B virus.
- Untreated, symptomatic, or corticosteroid-dependent central nervous system metastases.
- History of another malignancy within 3 years before enrollment, except tumors with negligible risk of metastasis or death, such as adequately controlled basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast.
- Is taking a prohibited concomitant medication specified in the protocol.
- Is receiving concurrent treatment in another investigational treatment study for cervical cancer.
- Has received a live vaccine within 30 days before study treatment. Injectable seasonal influenza vaccines are generally inactivated and are permitted; intranasal live attenuated influenza vaccines are prohibited.
- Is deprived of liberty, under guardianship or curatorship, or otherwise meets the legal definition of a vulnerable person under Regulation (EU) No. 536/2014.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Léon Bérard
Lyon
Isabelle RAY-COQUARD, MD, PhD
Isabelle RAY-COQUARD, MD,PhD
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris
Antoine Angelergues, MD
Antoine Angelergues, MD
About this study
Official title: Second Line Therapy and Beyond With Relacorilant and Nab-Paclitaxel for Cervical Cancer With Loss of Benefit From Immune Checkpoint and Platinum Exposure
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.
Read the detailed description
Recurrent or metastatic cervical cancer remains associated with poor outcomes after progression following platinum-based chemotherapy and immune checkpoint inhibitor therapy. Available subsequent treatment options are limited and are generally associated with modest clinical benefit.
Glucocorticoid receptor signaling may contribute to tumor cell survival, immune evasion, and resistance to anticancer therapy. Relacorilant is a selective glucocorticoid receptor modulator that may enhance sensitivity to taxane-based chemotherapy. The combination of relacorilant and nab-paclitaxel has demonstrated antitumor activity in previous clinical studies in other tumor types.
STELLA is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate relacorilant in combination with nab-paclitaxel in participants with recurrent or metastatic cervical cancer previously exposed to platinum-based chemotherapy and immune checkpoint inhibition, if eligible. Approximately 63 participants are planned to be enrolled at approximately 22 sites.
Nab-paclitaxel will be administered intravenously at 80 mg/m² on Days 1, 8, and 15 of each 28-day cycle. Relacorilant will be administered orally at 150 mg once daily on the day before, the day of, and the day after each nab-paclitaxel administration, except that relacorilant will not be administered on the day before the first nab-paclitaxel dose at Cycle 1 Day 1.
The primary endpoint is objective response rate according to RECIST version 1.1, defined as the proportion of participants achieving a complete response or partial response as their best overall response during the study. The study will also assess duration of response, progression-free survival, overall survival, safety, and exploratory translational objectives.
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Being tested
- Relacorilant, Nab-paclitaxel
- Keywords
- Relacorilant, Nab-paclitaxel, Cervical cancer, Recurrent cervical cancer, Metastatic cervical cancer, Glucocorticoid receptor, Immune checkpoint inhibitor, Platinum-based chemotherapy
- Medical subject headings
- Recurrence, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelacorilantDrug
Relacorilant 150 mg will be administered orally once daily on the day before, the day of, and the day after each nab-paclitaxel administration. Relacorilant will not be administered on the day before the first nab-paclitaxel dose at Cycle 1 Day 1. Treatment is administered in 28-day cycles.
Nab-paclitaxelDrug
Nab-paclitaxel 80 mg/m² will be administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Relacorilant and Nab-Paclitaxel | Experimental | Participants will receive relacorilant 150 mg orally in combination with nab-paclitaxel 80 mg/m² administered intravenously on Days 1, 8, and 15 of each 28-day cycle. Relacorilant will be administered once daily on the day before, the day of, and the day after each nab-paclitaxel infusion, except that relacorilant will not be administered on the day before the first nab-paclitaxel infusion at Cycle 1 Day 1. Treatment will continue until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. Receives: Drug: Relacorilant; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to RECIST v1.1
Objective Response Rate (ORR) is defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as their best overall response according to RECIST version 1.1, based on investigator assessment. Participants with early death, clinical progression, or treatment discontinuation due to toxicity before any tumor assessment will be considered treatment failures. Tumor assessments performed after initiation of subsequent anticancer therapy will not contribute to the ORR assessment.
Measured: From the date of first study treatment until documented disease progression, assessed up to 48 months.
Secondary outcomes (4)
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of first documented Complete Response (CR) or Partial Response (PR) until the date of documented disease progression according to RECIST version 1.1, as assessed by the investigator, or death from any cause.
Measured: From the date of first documented CR or PR until documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of first study treatment until the date of documented disease progression according to RECIST version 1.1, as assessed by the investigator, or death from any cause.
Measured: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first study treatment until death from any cause.
Measured: From the date of first study treatment until death from any cause, assessed up to 48 months.
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events, classified by maximum grade, System Organ Class (SOC), and Preferred Term (PT), according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Measured: From the first dose of study treatment until 30 days after the last dose of study treatment or until initiation of alternative cancer therapy, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ANGELERGUES, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-SimonIsabelle RAY-COQUARD, MD, PhD, Study chair, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763496
- Sponsor's protocol ID
- GINECO-CE201b
- Other IDs
- 2026-527245-22-00
- Acronym
- STELLA
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line Therapy and Beyond With Relacorilant and Nab-Paclitaxel for Cervical Cancer With Loss of Benefit From Immune Checkpoint and Platinum Exposure
- ClinicalTrials.gov ID
- NCT07763496
- Acronym / sponsor ID
- STELLA / GINECO-CE201b
- Conditions
- Recurrent or Metastatic Cervical Cancer
- Keywords
- Relacorilant, Nab-paclitaxel, Cervical cancer, Recurrent cervical cancer, Metastatic cervical cancer, Glucocorticoid receptor, Immune checkpoint inhibitor, Platinum-based chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recurrent or metastatic cervical cancer remains associated with poor outcomes after progression following platinum-based chemotherapy and immune checkpoint inhibitor therapy. Available subsequent treatment options are limited and are generally associated with modest clinical benefit.
Glucocorticoid receptor signaling may contribute to tumor cell survival, immune evasion, and resistance to anticancer therapy. Relacorilant is a selective glucocorticoid receptor modulator that may enhance sensitivity to taxane-based chemotherapy. The combination of relacorilant and nab-paclitaxel has demonstrated antitumor activity in previous clinical studies in other tumor types.
STELLA is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate relacorilant in combination with nab-paclitaxel in participants with recurrent or metastatic cervical cancer previously exposed to platinum-based chemotherapy and immune checkpoint inhibition, if eligible. Approximately 63 participants are planned to be enrolled at approximately 22 sites.
Nab-paclitaxel will be administered intravenously at 80 mg/m² on Days 1, 8, and 15 of each 28-day cycle. Relacorilant will be administered orally at 150 mg once daily on the day before, the day of, and the day after each nab-paclitaxel administration, except that relacorilant will not be administered on the day before the first nab-paclitaxel dose at Cycle 1 Day 1.
The primary endpoint is objective response rate according to RECIST version 1.1, defined as the proportion of participants achieving a complete response or partial response as their best overall response during the study. The study will also assess duration of response, progression-free survival, overall survival, safety, and exploratory translational objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relacorilant and Nab-Paclitaxel | Experimental | Drug: Relacorilant, Drug: Nab-paclitaxelParticipants will receive relacorilant 150 mg orally in combination with nab-paclitaxel 80 mg/m² administered intravenously on Days 1, 8, and 15 of each 28-day cycle. Relacorilant will be administered once daily on the day before, the day of, and the day after each nab-paclitaxel infusion, except that relacorilant will not be administered on the day before the first nab-paclitaxel infusion at Cycle 1 Day 1. Treatment will continue until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (30 listed)
- Grade ≥2 peripheral neuropathy.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Clinically relevant and reversible toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to Grade ≤1 before enrollment, except alopecia, hearing loss, vitiligo, and endocrinopathy managed with replacement therapy.
- Surgery within 4 weeks prior to enrollment or anticipated requirement for a surgical procedure during the study. Participants must have adequately recovered from toxicity and/or complications of prior major surgery.
- Has received any of the following before enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelacorilantRelacorilant 150 mg will be administered orally once daily on the day before, the day of, and the day after each nab-paclitaxel administration. Relacorilant will not be administered on the day before the first nab-paclitaxel dose at Cycle 1 Day 1. Treatment is administered in 28-day cycles. | Drug | Relacorilant and Nab-Paclitaxel |
| Nab-paclitaxelNab-paclitaxel 80 mg/m² will be administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle. | Drug | Relacorilant and Nab-Paclitaxel |
Primary outcome
Objective Response Rate (ORR) According to RECIST v1.1
Time frame: From the date of first study treatment until documented disease progression, assessed up to 48 months.
Objective Response Rate (ORR) is defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as their best overall response according to RECIST version 1.1, based on investigator assessment. Participants with early death, clinical progression, or treatment discontinuation due to toxicity before any tumor assessment will be considered treatment failures. Tumor assessments performed after initiation of subsequent anticancer therapy will not contribute to the ORR assessment.
4 secondary outcomes
Duration of Response (DoR)
Time frame: From the date of first documented CR or PR until documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Progression-Free Survival (PFS)
Time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Overall Survival (OS)
Time frame: From the date of first study treatment until death from any cause, assessed up to 48 months.
Incidence and Severity of Adverse Events
Time frame: From the first dose of study treatment until 30 days after the last dose of study treatment or until initiation of alternative cancer therapy, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Recurrent or Metastatic Cervical Cancer
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine ANGELERGUES, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
Isabelle RAY-COQUARD, MD, PhD study chair
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relacorilant and Nab-paclitaxel in people with Recurrent or Metastatic Cervical Cancer, run by ARCAGY/ GINECO GROUP at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidonie ADAM (+33 1 84 85 20 18, sadam@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to RECIST v1.1 (time frame: From the date of first study treatment until documented disease progression, assessed up to 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.