Squamous Cell Carcinoma of Head and NeckPhase 2PIONEERNCT04939480
Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab in Local SCCHN
A Phase 2 study testing Atezolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Targeting the PD-L1 pathway with atezolizumab has demonstrated objective responses across a broad range of malignancies including head and neck squamous cell carcinoma (SCCHN). MO39839 is a window of opportunity study investigating the feasibility, safety and postoperative complication rates of preoperative short time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 6 Oct 2021to 14 Mar 2024
- 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
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Written informed consent has to be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient. However, all screening examinations and laboratory results must have been obtained within 14 days before first study drug administration (initial tumor imaging: within 28 days before first study drug administration).
- Only patients for whom sufficient tumor material to be judged by the local investigator and which is of adequate quality can be included into the trial. Please refer to section 6.5 for further details on quantity and quality of tumor samples.
- Histologically or cytologically proven SCCHN (cT1-4a, cN0-3, cM0) that is amenable to surgical resection with curative intent based on the decision of the local multidisciplinary tumor board.
- Patients with relapse after primary radio(chemo)-therapy are allowed if a salvage surgery is possible (maximum 20%). Patients should have recovered from the effects of radiation: AE/sequelae should resolves to ≤ grade 2 (no minimum recovery period required).
- Male or female, 18 years of age or older on day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
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- Life expectancy >12 weeks
- Adequate hematologic and end-organ function, defined by laboratory test results, obtained within 14 days prior to initiation of study treatment
- Women of childbearing potential: Should have a negative urine or serum pregnancy test within 14 days prior to receiving the first dose of study medication. Agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after last study drug administration
Who cannot join
- Evidence of metastatic disease (M1)
- cT4b Stage
- Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 4 weeks prior to initiation of study treatment
- Bilateral pleural effusion
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- Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to Day 1, Cycle 1. Note: The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) is allowed
- Treatment with a live-attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study, and for 5 months after the last dose of atezolizumab
- Treatment with systemic immuno-stimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
- Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry
- Pregnant and lactating women
- Acute toxicities from previous therapy that have not resolved to Grade ≤ 1, except for alopecia
- Infections
- Positive human immunodeficiency virus (HIV): Known HIV+ patients may be included but must have:
- A stable regimen of highly active anti-retroviral therapy (HAART) No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
- Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening followed by a negative HBV DNA test, are eligible for the study. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening.
- The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 12.1 for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible provided that they meet the following conditions: Rash must cover less than 10% of the body surface area, disease is well controlled at baseline and only requires low potency topical steroids, and there are no acute exacerbations of underlying condition within the last 12 months (e.g. not requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency, or oral steroids)
- Adverse events (AE) related to any previous radiotherapy, chemotherapy, targeted therapy or surgical procedure that have not resolved to Grade ≤1, except alopecia (any grade) and Grade 2 neuropathy
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computer tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Active malignancy or a prior malignancy within the past 3 years. Patients with completely resected basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and patients with isolated elevation in prostate-specific antigen in the absence of radiographic evidence of metastatic prostate cancer are eligible for the study.
- Any Grade 3 or higher hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
- Increased corrected QT (QTc) interval (QTc > 470 ms)
- Family history of long QT syndrome or other risk factors for torsades de pointes
- History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
- Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 6 months prior to Cycle 1 Day 1, severe cardiac arrhythmia requiring medication or severe conduction abnormalities, unstable arrhythmias, acute coronary syndromes (including unstable angina), or history of coronary angioplasty/stenting/bypass grafting within past 6 months.
- Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded
- patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
- Participation in another clinical study within the last 3 months prior to inclusion or simultaneous participation in other clinical studies with an exception of studies evaluating radiological imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab (Tecentriq®) in Local Head and Neck Squamous Cell Carcinoma (the PIONEER Trial)
Targeting the PD-L1 pathway with atezolizumab has demonstrated objective responses across a broad range of malignancies including head and neck squamous cell carcinoma (SCCHN). MO39839 is a window of opportunity study investigating the feasibility, safety and postoperative complication rates of preoperative short time immunotherapy with atezolizumab in patients with local SCCHN. In the scope of MO39839 a comprehensive translational research program will be conducted to assess the potential effect of atezolizumab on dynamics in tumor immunity, and to identify and validate potential predictive and prognostic biomarkers.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Atezolizumab
- 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.
AtezolizumabDrug
Atezolizumab 1200 mg intravenous solution
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | Pre-operative administration of atezolizumab 1200 mg followed by definitive resection of the tumor, followed by standard of care radiotherapy or radio-chemotherapy. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of atezolizumab on tumor-infiltrating immune cells in resectable SCCHN
Percentage of patients with at least 2-fold increase of GzmB+/CD8+ T cells by immunohistochemistry (IHC) after 1 administration of atezolizumab between pre-treatment biopsy specimens and post-treatment resection specimens
Measured: 4 weeks
Feasibility of preoperative short time immunotherapy
Number of patients with completion of pre-operative immunotherapy and resection of SCCHN
Measured: 3 weeks
Secondary outcomes (7)
Safety of preoperative short time immunotherapy
Number and grade of AEs (CTC AE v5.0)
Measured: 58 days
Assessment of postoperative complication rates
Number and grade of AEs within 30 days postoperative (CTC AE v5.0)
Measured: 30 days
To assess dynamics in tumor immunity
Changes (measured as the relative frequency within total tumor infiltrating leukocytes determined by CD45 marker) in tumor infiltrating CD66b, CD68, CD3, CD19, CD56 positive immune cells between day 1 (biopsy) and day 21 (surgery specimen). Frequency will be determined by immunofluorescence and software-based image analysis.
Measured: 21 days
Characterization of changes in frequency of circulating immune cells
Changes (measured as the relative frequency within total circulating leukocytes determined by CD45 marker) in circulating CD66b, CD68, CD3, CD19, CD56 positive immune cells between day 1 and day 58. Frequency will be determined by flow cytometry.
Measured: 58 days
Resectability after immunotherapy
Number of patients with R0 or R1 resection
Measured: 4 weeks
Influence of immunotherapy on histo-morphological assessment
Changes of tumor-stroma ratio and total density of tumor infiltrating leukocytes between day 1 (biopsy) and day 21 (surgical specimen). Parameters will be assessed and quantified using immunofluorescence markers (EpCAM, cytokeratin, vimentin, CD45, DAPI) and digital pathology tools.
Measured: 21 days
(optional) set up of a registry for follow up of patients and subsequent documentation of relapse free survival (RFS) rate and overall survival (OS) rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start6 Oct 2021
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Kasper-Virchow, Prof. Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939480
- Sponsor's protocol ID
- MO39839
- Acronym
- PIONEER
- Status last verified
- Aug 2023
- First submitted
- 28 May 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kasper S, Winkel H, Hoing B, Bruderek K, Pogorzelski M, Deuss E, Grunewald I, Doreth C, Wang X, Theurer S, Arakawa-Hoyt J, Maitra S, Guberina M, Virchow I, Schuler M, Spitzer MH, Lang S, Kurten CH, Brandau S. Pre-existing systemic immune state and dynamic myeloid remodeling shape response to neoadjuvant PD-L1 blockade. J Immunother Cancer. 2026 Aug 26;14(8):e015762. doi: 10.1136/jitc-2026-015762.
PubMed 42648751
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab (Tecentriq®) in Local Head and Neck Squamous Cell Carcinoma (the PIONEER Trial)
- ClinicalTrials.gov ID
- NCT04939480
- Acronym / sponsor ID
- PIONEER / MO39839
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Targeting the PD-L1 pathway with atezolizumab has demonstrated objective responses across a broad range of malignancies including head and neck squamous cell carcinoma (SCCHN). MO39839 is a window of opportunity study investigating the feasibility, safety and postoperative complication rates of preoperative short time immunotherapy with atezolizumab in patients with local SCCHN. In the scope of MO39839 a comprehensive translational research program will be conducted to assess the potential effect of atezolizumab on dynamics in tumor immunity, and to identify and validate potential predictive and prognostic biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab | Experimental | Drug: AtezolizumabPre-operative administration of atezolizumab 1200 mg followed by definitive resection of the tumor, followed by standard of care radiotherapy or radio-chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Written informed consent has to be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient. However, all screening examinations and laboratory results must have been obtained within 14 days before first study drug administration (initial tumor imaging: within 28 days before first study drug administration).
- Only patients for whom sufficient tumor material to be judged by the local investigator and which is of adequate quality can be included into the trial. Please refer to section 6.5 for further details on quantity and quality of tumor samples.
- Histologically or cytologically proven SCCHN (cT1-4a, cN0-3, cM0) that is amenable to surgical resection with curative intent based on the decision of the local multidisciplinary tumor board.
- Patients with relapse after primary radio(chemo)-therapy are allowed if a salvage surgery is possible (maximum 20%). Patients should have recovered from the effects of radiation: AE/sequelae should resolves to ≤ grade 2 (no minimum recovery period required).
- Male or female, 18 years of age or older on day of signing informed consent
Key exclusion criteria (43 listed)
- Evidence of metastatic disease (M1)
- cT4b Stage
- Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 4 weeks prior to initiation of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab 1200 mg intravenous solution | Drug | Atezolizumab |
Primary outcome
Effect of atezolizumab on tumor-infiltrating immune cells in resectable SCCHN
Time frame: 4 weeks
Percentage of patients with at least 2-fold increase of GzmB+/CD8+ T cells by immunohistochemistry (IHC) after 1 administration of atezolizumab between pre-treatment biopsy specimens and post-treatment resection specimens
Feasibility of preoperative short time immunotherapy
Time frame: 3 weeks
Number of patients with completion of pre-operative immunotherapy and resection of SCCHN
7 secondary outcomes
Safety of preoperative short time immunotherapy
Time frame: 58 days
Assessment of postoperative complication rates
Time frame: 30 days
To assess dynamics in tumor immunity
Time frame: 21 days
Characterization of changes in frequency of circulating immune cells
Time frame: 58 days
Resectability after immunotherapy
Time frame: 4 weeks
Influence of immunotherapy on histo-morphological assessment
Time frame: 21 days
(optional) set up of a registry for follow up of patients and subsequent documentation of relapse free survival (RFS) rate and overall survival (OS) rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 42648751Kasper S, Winkel H, Hoing B, Bruderek K, Pogorzelski M, Deuss E, Grunewald I, Doreth C, Wang X, Theurer S, Arakawa-Hoyt J, Maitra S, Guberina M, Virchow I, Schuler M, Spitzer MH, Lang S, Kurten CH, Brandau S. Pre-existing systemic immune state and dynamic myeloid remodeling shape response to neoadjuvant PD-L1 blockade. J Immunother Cancer. 2026 Aug 26;14(8):e015762. doi: 10.1136/jitc-2026-015762.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Kasper-Virchow, Prof. Dr. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by University Hospital, Essen at 1 site 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 9 inclusion and 43 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Effect of atezolizumab on tumor-infiltrating immune cells in resectable SCCHN (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT04939480, which also lists 1 linked publication.
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 25 Apr 2024.