Postoperative adjuvant radiochemotherapy (aRCH) with Cisplatin (C) versus aRCH with C and Pembrolizumab (P) in locally advanced head and neck squamous cell carcinoma (HNSCC); multicenter randomized Phase II study within the German interdisciplinary study group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk - ADRISK

niversity Leipzig0 sites240 target enrollmentMarch 1, 2018

ConditionsAdvanced primary resectable stage III, IVA/B head and neck squamous cell carcinoma (HNSCC)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced primary resectable stage III, IVA/B head and neck squamous cell carcinoma (HNSCC)
Sponsor: niversity Leipzig
Enrollment: 240
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 1, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Leipzig

Eligibility Criteria

Inclusion Criteria

•1\.Macroscopically complete resection of newly diagnosed advanced squamous\-cell carcinoma arising in the oral cavity, oropharynx, larynx, or hypopharynx
•2\. Advanced stage III, IVA/B HNSCC according to the TNM classification version 7th edition (Note! The 8th edition will not be used, please adhere to the national cancer institute guidelines)
•3\.Eastern Cooperative Oncology Group performance status of 0 to 1
•4\.Had either intermediate or high\-risk characteristics, i.e. any or all of the following:
•histologic evidence of invasion of two or more regional lymph nodes
•extracapsular extension of nodal disease,
•microscopically involved mucosal margins of resection (R1\) or margins of resection \<\= 5mm (R0\)
•5\.Had pathological histologic assessment of p16 (only oropharyngeal carcinoma)
•6\.Be \>\= 18 years
•7\.Written informed consent

Exclusion Criteria

•1\.Concurrent participation in any other interventional clinical trial or participation in any other interventional trial within one month before enrolment into this trial.
•2\.Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrolment into this trial.
•3\.Known history of active TB (Bacillus Tuberculosis)
•4\.Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its excipients.
•5\.Prior anti\-cancer monoclonal antibody (mAb) therapy within one month before enrolment into this trial or who has not recovered (i.e., \= Grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to agents administered more than one month earlier.
•6\.Prior chemotherapy, targeted small molecule therapy, or radiation therapy within one month before enrolment into this trial or who has not recovered (i.e., \= grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to a previously administered agent.
•a.Note: Subjects with \= Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study.
•b.Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•7\.Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•8\.Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrolment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.