Trials Sponsors Conditions Drugs Pricing

Conditions

Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases

Keywords

cervical cancerlymph node metastasesFIGO IIB

Outcome Measures

Primary Outcomes (2)

Progression free survival (PFS)
Tumor response assessed by MRI Pelvic according to resist
From Baseline to 2 years
The adverse events according to NCI-CTCAE v5.0
Safety and tolerability (according to NCI-CTCAE v5.0)
From the time of signed informed consent until 100 days after the last study drug administration

Study Arms (1)

Study medication

EXPERIMENTAL

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

Drug: Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)Drug: Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab)Procedure: Maintenance Treatment (Nivolumab/Ipilimumab)

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.

Study medication

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).

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Fully-informed written consent.
Females ≥ 18 years of age

Sponsors & Collaborators

ZKS Köln
Othercollaborator
Universitätsklinikum Köln
Otherlead

MeSH Terms

Conditions

Lymphatic MetastasisUterine Cervical Neoplasms

Interventions

NivolumabIpilimumab

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical Diseases

Study Officials

Simone Marnitz, Prof.
Department of Radiation Oncology, University Hospital of Cologne
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

August 17, 2022

Study Start

November 1, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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.
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.
Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
Subjects with a history of or current CNS metastases. A scan to confirm the absence of brain metastases is not required. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and/or MRI scans.
Pregnant or breast-feeding women.
Any positive test result for hepatitis B virus (e.g. surface antigen \[HBV sAg, Australia antigen\] positive) or hepatitis C virus (Hepatic C antibody \[anti-HCV\] positive, except if HCV-RNA negative.
Immunocompromised patients, e.g. patients with positive testing for HIV at screening visit or those under corticoid medication or immunosuppressive drugs (e.g. methotrexate).
Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the coordinating investigator be consulted prior to signing informed consent.
+6 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Study medication

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Study medication

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record