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

Universitätsklinikum Köln0 sitesNovember 1, 2023

ConditionsCervical Cancer ≥ FIGO IIB and or Lymph Node Metastases

InterventionsPre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab)Maintenance Treatment (Nivolumab/Ipilimumab)

DrugsPre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab)

Overview

Phase: Phase 2
Intervention: Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)
Conditions: Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases
Sponsor: Universitätsklinikum Köln
Primary Endpoint: Progression free survival (PFS)
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2023

End Date

July 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Universitätsklinikum Köln

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fully-informed written consent.
•Females ≥ 18 years of age
•Histologically confirmed squamous cell, adeno- adenosquamous carcinoma of the cervix uteri. Surgical staging prior to treatement is optional.
•FIGO stage ≥ IIB and/or histologically confirmed pelvic lymph node metastases.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•Adequate bone marrow, hepatic and renal function including the following:
•Haemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1,500 /µL, platelets ≥100,000 /µL;
•Total bilirubin ≤ 1.5 x upper normal limit; (except subjects with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL);
•AST (SGOT), ALT (SGPT) ≤ 3 x upper normal limit;
•International normalized ratio (INR) ≤ 1.25;

Exclusion Criteria

•Previous systemic therapy in the first-line setting.
•Patients with neuroendocrine (small cell or large cell) tumors or mixed neuroendocrine histology.
•Patients with histologically confirmed para-aortic lymph node metastases.
•Prior organ allograft or allogeneic bone marrow transplantation.
•Local therapies ongoing or completed \<4 weeks prior to the baseline scan.
•Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
•Prior, systemic anti-cancer chemotherapy, radiotherapy administered \<4 weeks prior to study entry, endocrine- or immunotherapy or use of other investigational agents.
•Major surgery within 4 weeks of starting the study. Patients must have recovered from effects of major surgery.
•Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS rate \>90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
•Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.

Arms & Interventions

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

Intervention: Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)