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

NCT03480672 | Completed Phase 2 DMC

• 1 other identifier: ADRISK
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• Event Free Survival (EFS)

  time from randomization to the first event (i.e. locoregional or distant recurrence, initiation of a new anti-cancer treatment death from any cause)

  24 months

Secondary Outcomes (1)

• Overall survival (OS)

  24 months

Study Arms (2)

Pembrolizumab + aRCH

EXPERIMENTAL

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]; Other: adjuvant radiochemotherapy

aRCH

ACTIVE COMPARATOR

adjuvant radio-chemotherapy (aRCH)

Other: adjuvant radiochemotherapy

Interventions

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] DRUG

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

Pembrolizumab + aRCH

adjuvant radiochemotherapy OTHER

adjuvant radiochemotherapy with cisplatin

Pembrolizumab + aRCH; aRCH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Macroscopically complete resection of newly diagnosed (not recurrent, not secondary primary) advanced squamous-cell carcinoma arising in the oral cavity, oropharynx, larynx, or hypopharynx
• 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)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; performance status allows adjuvant chemo radiation with cisplatin.
• 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)
• Had pathological histologic assessment of p16 (only oropharyngeal carcinoma)
• Be \> 18 years of age
• Written informed consent
• Demonstrate adequate organ function
• Female subject of childbearing potential should have a negative pregnancy test within 3 days prior to receiving the first dose of study medication.
• 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.
• 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

You may not qualify if:

• Concurrent participation in any other interventional clinical trial or participation in any other interventional trial within one month before enrolment into this trial.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrolment into this trial.
• Known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its excipients.
• 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.
• 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.
• Note: Subjects with ≤ Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• 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.
• 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.
• 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.
• Active infection requiring systemic therapy.
• Suspected lack of compliance
• 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.
• HIV, HBV or HCV infection

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (16)

Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK

Berlin, Germany

Location

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

Berlin, Germany

Location

Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin

Bielefeld, Germany

Location

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

Bonn, Germany

Location

Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie

Düsseldorf, Germany

Location

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

Erfurt, Germany

Location

Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie

Essen, Germany

Location

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

Hamburg, Germany

Location

Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde

Jena, Germany

Location

Department of Head Medicine and Oral Health, University of Leipzig

Leipzig, 04103, Germany

Location

UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Location

Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik

Mannheim, Germany

Location

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

Potsdam, Germany

Location

Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

Regensburg, Germany

Location

Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie

Stuttgart, Germany

Location

Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie

Würzburg, Germany

Location

Related Publications (2)

• Wiegand S, Wichmann G, Vogt J, Vogel K, Franke A, Kuhnt T, Lordick F, Scheuble AM, Hambsch P, Brossart P, Bauernfeind FG, Kaftan H, Maschmeyer G, Paland M, Munter M, Lewitzki V, Rotter N, Stromberger C, Beck M, Dommerich S, Gauler TC, Hapke G, Guntinas-Lichius O, Schroder U, Gorner M, Hautmann MG, Steger F, Tamaskovics B, Schmiedeknecht A, Dietz A. Postoperative adjuvant radiochemotherapy with cisplatin versus adjuvant radiochemotherapy with cisplatin and pembrolizumab in locally advanced head and neck squamous cell carcinoma- the study protocol of the Adrisk trial. Front Oncol. 2023 Mar 21;13:1128176. doi: 10.3389/fonc.2023.1128176. eCollection 2023.

  PMID: 37025596 BACKGROUND

• A. Dietz, S. Wiegand, J. Vogt, K. Vogel, A. Schmiedeknecht, A. Schrock, T. Kuhnt, P. Hambsch, N. Nicolay, F. Lordick, A.M. Scheuble, P. Brossart, F.-G. Bauernfeind, G. Feldmann, S. Parade, H. Kaftan, S. Wohlfarth, M. Jungehülsing, M. Paland, G. Maschmeyer, G. Hapke, P. Ebeling, N. Rotter, A. Affolter, M. Muenter, F. Zangos, D. Hahn, V. Lewitzki, U. Müller-Richter, S. Hackenberg, C. Stromberger, M. Heiland, S. Dommerich, M. Beck, T.C. Gauler, S. Lang, B.F. Tamaskovics, W. Budach, U. Schroeder, D. Rades, M. Görner, M. Hautmann, F. Steger, O. Guntinas-Lichius, K. Pietschmann, M. Pirlich, T. Wald, A. Franke, G. Wichmann 1320O Postoperative adjuvant radiochemotherapy with cisplatin (aRCH) vs. aRCH plus pembrolizumab in locally advanced head and neck squamous cell carcinoma (HNSCC): First data of the ADRISK trial Annals of Oncology Volume 36, Supplement 2, September 2025, Page S769

  RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab; Chemoradiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chemoradiotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Andreas Dietz, Prof. Dr.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: August 6, 2018
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-04

Locations

DE (16)