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Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer

NCT07763496 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-08-13

No results posted yet for this study

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

Interventions

DRUG

Relacorilant

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.

DRUG

Nab-paclitaxel

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

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Antoine ANGELERGUES, MD · Groupe Hospitalier Diaconesses Croix Saint-Simon

  • Isabelle RAY-COQUARD, MD, PhD · Centre Leon Berard

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763496 on ClinicalTrials.gov