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Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer

ConditionRecurrent or Metastatic Cervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorARCAGY/ GINECO GROUP

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Nab-paclitaxel

    Drug

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

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: Relacorilant and Nab-PaclitaxelExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARCAGY/ GINECO GROUP

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: