Relacorilant and Nab-Paclitaxel in Recurrent 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
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
Treatments tested in this trial
- Relacorilant
- Nab-paclitaxel
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov