Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT05492123
Phase
PHASE2
Status
Recruiting
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Conditions

  • Uterine Cervical Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 40 mg in 4 ml Injection — DRUG
    Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
  • Ipilimumab 200 MG in 40 ML Injection — DRUG
    Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
  • Chemoradiation — RADIATION
    Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w

Study Details

A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.

Key Dates

Start date
Aug 30, 2022
Status verified
Jan 2023
Primary completion
Dec 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Chemoradiation
    Traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week
  • Experimental: Immunotherapy
    4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks.

Primary Outcome Measure

3-year progression-free survival [ Time Frame: 3 years ]

Central Contacts

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