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HNSCCPhase 2NCT03480672

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

A Phase 2 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] and adjuvant radiochemotherapy in people with HNSCC, run by University of Leipzig at 16 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HNSCC
What is being tested?
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] and adjuvant radiochemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
16 sitesGermany
Study dates
6 Aug 2018to 30 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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.
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  • 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
  • Application of a live vaccine within one month of enrolment.
  • Hypersensitivity to cisplatin or any of its excipients
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK

    Berlin

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

    Berlin

  • Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin

    Bielefeld

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

    Bonn

  • Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie

    Düsseldorf

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

    Erfurt

  • Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie

    Essen

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

    Hamburg

  • Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde

    Jena

  • Department of Head Medicine and Oral Health, University of Leipzig

    Leipzig, 04103

  • UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik

    Mannheim

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

    Potsdam

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

    Regensburg

  • Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie

    Stuttgart

  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie

    Würzburg

Other trials in Germany

About this study

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

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
Being tested
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA], adjuvant radiochemotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Drug

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

  • adjuvant radiochemotherapyOther

    adjuvant radiochemotherapy with cisplatin

Study groups in NCT03480672
Study groupRoleWhat they receive
Pembrolizumab + aRCHExperimentalApplication of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)
Receives: Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]; Other: adjuvant radiochemotherapy
aRCHActive comparatoradjuvant radio-chemotherapy (aRCH)
Receives: Other: adjuvant radiochemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 months

Secondary outcomes (1)

  1. Overall survival (OS)

    time from randomization to death from any cause

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start6 Aug 2018
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480672
Sponsor's protocol ID
ADRISK
Status last verified
Apr 2025
First submitted
21 Mar 2018
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37025596

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] and adjuvant radiochemotherapy in people with HNSCC, run by University of Leipzig at 16 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (EFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480672, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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