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Clinical Trials/EUCTR2017-000353-39-IT
EUCTR2017-000353-39-IT
Active, not recruiting
Phase 1

The CONFRONT Phase I – II Trial: ACtivatiON oF immune RespONse in paTients with R-M Head and Neck Cancer. Multimodality immunotherapy with Avelumab, short course radiotherapy and Cyclophosphamide in Head and Neck cancer. - CONFRONT

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 sites71 target enrollmentApril 6, 2018
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ConditionsR-M Head and Neck CancerMedDRA version: 20.0Level: PTClassification code 10034813Term: Pharyngeal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10055104Term: Pharyngeal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBAVENCIOENDOXAN

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
R-M Head and Neck Cancer
Sponsor
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
Enrollment
71
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2018
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

Eligibility Criteria

Inclusion Criteria

  • •1\.Be willing and able to provide written informed consent for the trial. The subject may also provide consent for the translational study.
  • •2\.Be \= 18 years of age on day of signing informed consent.
  • •3\.ECOG Performance Status 0\-2\.
  • •4\.Have histologically or cytologically\-confirmed recurrent or metastatic (disseminated) head and neck squamous cell carcinoma
  • •5\.Have a disease progression after treatment with at least one line of therapy including at least Cisplatin, Fluorouracil and Cetuximab for recurrent (disease not amenable to curative treatment)/metastatic disease.
  • •6\.Measurable disease by RECIST criteria.
  • •7\.At least one metastatic site suitable for irradiation
  • •8\.Life expectancy \> 3 months.
  • •9\.Adequate bone marrow function: neutrophils \= 1\.5 x 109/L, platelets \= 100 x 109/L, hemoglobin \=9 g/dL.
  • •10\.Adequate liver function: AST and ALT levels \= 2\.5 × ULN; bilirubin \= 1\.5 x ULN.

Exclusion Criteria

  • •1\.History of malignant disease (with the exception of non\-melanoma skin tumours and/or in situ cervical cancer) in the preceding five years.
  • •2\.Brain metastases.
  • •3\.Autoimmune disorders. Patients with diabetes type I, vitiligo, psoriasis, or hypo\- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
  • •4\.Allergic disorders.
  • •5\.Cyclophosphamide treatment contraindications:
  • •a.Cystitis.
  • •b.Urinary Obstruction.
  • •c.Inadequate bone marrow function: WBC \<2900 mm3 and/or HCT \<30% and/or platelets count \<90000 mm3\.
  • •d.Active infections.
  • •e.Pregnancy or breast feeding.

Outcomes

Primary Outcomes

Not specified

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