We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480672
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Andreas Dietz, University of Leipzig

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This trial evaluates the addition of pembrolizumab to standard postoperative adjuvant radiochemotherapy in the treatment of patients with locally advanced intermediate and high risk head and neck squamous cell carcinoma (HNSCC).

Condition or disease Intervention/treatment Phase
HNSCC Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] Other: adjuvant radiochemotherapy Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Pembrolizumab + aRCH
Application of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)
 Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
intravenous application, 12 months, in 3-week cycle (q3w) 200 mg

Other: adjuvant radiochemotherapy
adjuvant radiochemotherapy with cisplatin
Active Comparator: aRCH
adjuvant radio-chemotherapy (aRCH)
 Other: adjuvant radiochemotherapy
adjuvant radiochemotherapy with cisplatin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 24 months ]
    time from randomization to the first event (i.e. locoregional or distant recurrence, initiation of a new anti-cancer treatment death from any cause)


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 24 months ]
    time from randomization to death from any cause


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Macroscopically complete resection of newly diagnosed (not recurrent, not secondary primary) 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 (ECOG) performance status of 0 to 1; performance status allows adjuvant chemo radiation with cisplatin.

  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 of age
  7. Written informed consent
  8. Demonstrate adequate organ function
  9. Female subject of childbearing potential should have a negative pregnancy test within 3 days prior to receiving the first dose of study medication.
  10. Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication.
  11. Reproductive male subjects must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy

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.

    1. Note: Subjects with ≤ Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study.
    2. 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.
  9. Evidence of interstitial lung disease or history of (non-infectious) pneumonitis that required steroids within the last 6 months before enrolment into this trial, or current pneumonitis.
  10. Active infection requiring systemic therapy.
  11. Suspected lack of compliance
  12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the baseline visit through 120 days after the last dose of trial treatment.
  13. HIV, HBV or HCV infection
  14. Application of a live vaccine within one month of enrolment.
  15. Hypersensitivity to cisplatin or any of its excipients
  16. Any potential relationship to the investigator/his deputy or to medical staff of the study team, to the coordinating investigator or is an employee of the study sit
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480672


Contacts
Layout table for location contacts
Contact: Andreas Dietz, Prof. Dr. 0049 34197 ext 21700 andreas.dietz@medizin.uni-leipzig.de
Contact: Anett Schmiedeknecht, Dr. 0049 34197 ext 16256 anett.schmiedeknecht@zks.uni-leipzig.de

Locations
Layout table for location information
Germany
Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK Recruiting
Berlin, Germany
Contact: Marcus Beck, Dr.         
Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde Recruiting
Berlin, Germany
Contact: Steffen Dommerich, Dr.         
Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin Recruiting
Bielefeld, Germany
Contact: Martin Görner, Dr.         
Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie Recruiting
Bonn, Germany
Contact: Peter Brossart, Prof. Dr.         
Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie Recruiting
Düsseldorf, Germany
Contact: Balint Tamaskovics, Dr.         
Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde Recruiting
Erfurt, Germany
Contact: Holger Kaftan, Prof. Dr.         
Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie Recruiting
Essen, Germany
Contact: Christoph Gauler, Dr.         
Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie Recruiting
Hamburg, Germany
Contact: Gunnar Hapke, Dr.         
Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde Recruiting
Jena, Germany
Contact: Orlando Guntinas-Lichius, Prof. Dr.         
Department of Head Medicine and Oral Health, University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Andreas Dietz, Prof. Dr.         
UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany
Contact: Ursula Schröder, Dr.         
Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik Recruiting
Mannheim, Germany
Contact: Nicole Rotter, Prof. Dr.         
Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und Recruiting
Potsdam, Germany
Contact: Matthias Paland, Dr.         
Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie Recruiting
Regensburg, Germany
Contact: Matthias Hautmann, Dr.         
Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie Recruiting
Stuttgart, Germany
Contact: Marc Münter, Prof. Dr.         
Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie Recruiting
Würzburg, Germany
Contact: Victor Lewitzki, Dr.         
Sponsors and Collaborators
University of Leipzig
Investigators
Layout table for investigator information
Principal Investigator: Andreas Dietz, Prof. Dr. University Leipzig
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Andreas Dietz, Prof. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT03480672    
Other Study ID Numbers: ADRISK
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action