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

NCT ID: NCT03480672

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2025-01-30

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).

Conditions

HNSCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab + aRCH

Application of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)

Group Type: EXPERIMENTAL

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Intervention Type: DRUG

intravenous application, 12 months, in 3-week cycle (q3w) 200 mg

adjuvant radiochemotherapy

Intervention Type: OTHER

adjuvant radiochemotherapy with cisplatin

aRCH

adjuvant radio-chemotherapy (aRCH)

Group Type: ACTIVE_COMPARATOR

adjuvant radiochemotherapy

Intervention Type: OTHER

adjuvant radiochemotherapy with cisplatin

Interventions

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

intravenous application, 12 months, in 3-week cycle (q3w) 200 mg

Intervention Type: DRUG

adjuvant radiochemotherapy

adjuvant radiochemotherapy with cisplatin

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Andreas Dietz

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Dietz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Leipzig

Locations

Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK

Berlin, , Germany

Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde

Berlin, , Germany

Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin

Bielefeld, , Germany

Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie

Bonn, , Germany

Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie

Düsseldorf, , Germany

Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde

Erfurt, , Germany

Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie

Essen, , Germany

Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie

Hamburg, , Germany

Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde

Jena, , Germany

Department of Head Medicine and Oral Health, University of Leipzig

Leipzig, , Germany

UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik

Mannheim, , Germany

Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und

Potsdam, , Germany

Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

Regensburg, , Germany

Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie

Stuttgart, , Germany

Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie

Würzburg, , Germany

Countries

Germany

Other Identifiers

ADRISK

Identifier Type: -

Identifier Source: org_study_id