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

Conditions

• LOCALLY ADVANCED CERVICAL CANCERS

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• combination of relatlimab and nivolumab wich are two immunotherapy treatments — COMBINATION_PRODUCT
  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
• Nivolumab alone — OTHER
  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

Study Details

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

Key Dates

Start date

Dec 11, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

77 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Nivolumab and relatlimab
• Other: Arm B: Nivolumab only

Primary Outcome Measure

Primary outcome [ Time Frame: From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days ]