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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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-paclitaxel 80 mg/m² will be administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle.
Centre Léon Bérard
Lyon, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
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.
Time frame: From the date of first study treatment until documented disease progression, assessed up to 48 months.
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.
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)
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.
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)
Overall Survival (OS) is defined as the time from the date of first study treatment until death from any cause.
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
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.
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.
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