Chemo-radio-immunotherapy With Nivolumab and Ipilimumab Treatment in Locally Advanced Cervical Cancer Patients

Conditions

• Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab) — DRUG
  Two weeks before start of Chemo-radio-immunotherapy one administration of Nivolumab 3 mg/kg and Ipilimumab 1 mg/kg IV over 30 minutes, with a 30 minute break between Nivolumab and Ipilimumab.
• Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab) — DRUG
  In week 1-7, standard administration of concurrent Cisplatin mono 40mg/m2 body surface area d1, 8, 15, 22, 29 (Monday of each treatment week) during radiotherapy. Simultaneous application of Nivolumab 3mg/kg week 1, 3, 5, 7 (on Thursday) and Ipilimumab 1mg/kg in week 5 (on Thursday).
• Maintenance Treatment (Nivolumab/Ipilimumab) — PROCEDURE
  For six months after Chemo-radio-immunotherapy, Nivolumab 3mg/kg every two weeks x12 (week +2, +4, +6, +8, +10, +12, +14, +16, +18, +20, +22, +24 (twelve applications), each application over 30 minutes and Ipilimumab every six weeks x4 (week +6,+12, +18, +24).

Study Details

The purpose of this study is to use Chemo-radio-immunotherapy and maintenance therapy with Nivolumab and Ipilimumab in order to achieve improved outcome in patients with locally advanced cervical cancer.

Key Dates

Start date

Nov 1, 2023

Status verified

Apr 2023

Primary completion

Jun 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Study medication
  All eligible patients will receive study medication: * Pre-Chemo-radio-immunotherapy Treatment for two weeks before start of Chemo-radio-immunotherapy * Concurrent Chemo-radio-immunotherapy (week 1-7) * Maintenance Treatment (six months) after Chemo-radio-immunotherapy

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From Baseline to 2 years ]