NCT05504642

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

Nivolumab and Ipilimumab for Chemo-radio-immunotherapy Followed by Maintenance Therapy With Nivolumab and Ipilimumab for Primary Treatment in Locally Advanced Cervical Cancer Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Universitätsklinikum Köln · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a Pre-Chemo-radio-immunotherapy Treatment with Nivolumab and Ipilimumab for 2 weeks. In the following week 1-7, concurrent Chemo-radio-Immunotherapy will consist of standard administration of concurrent Cisplatin mono during radiotherapy, with simultaneous application of Nivolumab and Ipilimumab according to trial protocol. This is followed by Maintenance Treatment for 6 months with Nivolumab and Ipilimumab according to trial protocol.

Conditions

• Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases

Interventions

Type	Name	Description
DRUG	Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)	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.
DRUG	Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab)	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).
PROCEDURE	Maintenance Treatment (Nivolumab/Ipilimumab)	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).

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2022-08-17
• Last updated: 2023-04-18