NCT06715241

A MULTICENTER, SEEKING SIGNAL, RANDOMISED, OPEN-LABEL PHASE II OF RELATLIMAB AND NIVOLUMAB VS NIVOLUMAB ALONE IN LOCALLY ADVANCED CERVICAL CANCERS

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, randomized, seeking signal (non-comparative), Phase II aiming to assess the clinical activity of the combination relatlimab + nivolumab in locally advanced cervical cancer eligible to standard CCRT

Detailed description

Primary Objective \* To evaluate the clinical activity of relatlimab and nivolumab induction treatment before standard CCRT in locally advanced cervical cancer Secondary Objectives * To further document the clinical activity of relatlimab and nivolumab * To document the safety of the proposed combination in the target population Exploratory Objectives * To identify candidate biomarkers that may correlate with likelihood of clinical benefit/response using serial blood and tumor sample collection. * To explore the factors (including biomarkers) that may influence response (where response is defined broadly to comprise efficacy, tolerability or safety) or to explore mechanisms of resistance to study treatment.

Conditions

• LOCALLY ADVANCED CERVICAL CANCERS

Interventions

Type	Name	Description
COMBINATION_PRODUCT	combination of relatlimab and nivolumab wich are two immunotherapy treatments	Induction: Nivolumab 360 mg/relatlimab 360 mg fixed dose combination, IV, 6 weeks Off treatment period: 4 to 6 weeks Maintenance: Nivolumab 480 mg/relatlimab 480 mg fixed dose combination, IV 13 cycles (Q4W): 52 weeks
OTHER	Nivolumab alone	Induction: Nivolumab alone 360 mg, IV2 cycles (Q3W): 6 weeks Off treatment period: 4 to 6 weeks Maintenance: Nivolumab alone 480 mg, IV, 13 cycles (Q4W): 52 weeks

Timeline

• Start date: 2024-12-11
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2024-12-04
• Last updated: 2026-01-22

Locations

30 sites across 1 country: France