COL Immunotherapy Before Radiochimio + Ipilimumab

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT04256213
Status
Completed

Conditions

  • Cervix Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab and Ipilimumab — DRUG
    Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)

Study Details

This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy

Key Dates

Start date
Jul 2, 2020
Status verified
Dec 2024
Primary completion
Aug 30, 2021
Completion
Aug 4, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Nivolumab + Ipilimumab

Primary Outcome Measure

CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies [ Time Frame: Baseline, before RT-CT ]

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