Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer

NCT07763496 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: GINECO-CE201b2026-527245-22-00
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From the date of first study treatment until documented disease progression, assessed up to 48 months.

Secondary Outcomes (4)

• Duration of Response (DoR)

  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)

  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)

  From the date of first study treatment until death from any cause, assessed up to 48 months.

• Incidence and Severity of Adverse Events

  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.

Study Arms (1)

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.

Drug: Relacorilant; Drug: Nab-paclitaxel

Interventions

Relacorilant DRUG

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.

Relacorilant and Nab-Paclitaxel

Nab-paclitaxel DRUG

Nab-paclitaxel 80 mg/m² will be administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle.

Relacorilant and Nab-Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (2)

Centre Léon Bérard

Lyon, France

Location

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, France

Location

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Interventions

relacorilant; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antoine ANGELERGUES, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

• Isabelle RAY-COQUARD, MD, PhD

  Centre Leon Berard

  STUDY CHAIR

Central Study Contacts

Sidonie ADAM

CONTACT

+33 1 84 85 20 18; sadam@arcagy.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

FR (2)