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NOT YET RECRUITING
NCT07763496
PHASE2

Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer

Sponsor: ARCAGY/ GINECO GROUP

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-10

Completion Date

2030-12

Last Updated

2026-08-13

Healthy Volunteers

No

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.

Locations (2)

Centre Léon Bérard

Lyon, France

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, France