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

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ClinicalTrials.gov Identifier: NCT03480672
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Andreas Dietz, University of Leipzig

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE August 6, 2018
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
Overall survival (OS) [ Time Frame: 24 months ]
time from randomization to death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HNSCC
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Pembrolizumab + aRCH
    Application of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)
    Interventions:
    • Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
    • Other: adjuvant radiochemotherapy
  • Active Comparator: aRCH
    adjuvant radio-chemotherapy (aRCH)
    Intervention: Other: adjuvant radiochemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480672
Other Study ID Numbers  ICMJE ADRISK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andreas Dietz, University of Leipzig
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Dietz, Prof. Dr. University Leipzig
PRS Account University of Leipzig
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP