Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT03426657
Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC
A Phase 2 study testing Durvalumab + Tremelimumab + RT in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by University of Erlangen-Nürnberg Medical School at 7 sites in Germany.
Trial summary
First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Durvalumab + Tremelimumab + RT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesGermany
- Study dates
- 20 Sep 2018to 29 Feb 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening Evaluations.
- Age > 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
- Locally advanced HNSCC, UICC stage III-IVB (oral cavity, oropharynx, hypopharynx, supraglottic larynx)
- Histological confirmation of HNSCC (regardless if p16 positive or negative)
- Measureable CD8 density in provided archival tumor tissue
Show all 15Show fewer
- Body weight >30kg
- Adequate normal organ and marrow function as defined: Haemoglobin ≥ 9.0 g/dL; White blood cells (WBC) ≥ 3,000 per mm3; Platelet count >100,000 per mm3
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
- Creatinine Clearance >40ml/min (calculated from serum creatinine or cystatin C, alternatively 24h urine possible)
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Participation in another clinical study with an investigational product during the last 4 weeks
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Distant metastases
- Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced HNSCC
- Any other concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment, except the induction chemotherapy in the protocol. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Show all 36Show fewer
- Prior radiotherapy of HNSCC
- Radiotherapy to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- Major surgical procedure of the current locally advanced HNSCC (as defined by the Investigator). Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia areata
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab + tremelimumab combination therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
- Known allergy or hypersensitivity to durvalumab, tremelimumab, cisplatin/carboplatin, docetaxel or any excipient
- Cisplatin/carboplatin induced polyneuropathy or hearing disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinik Chemnitz gGmbH
Chemnitz, 09116
Dresden, Onkologische Gemeinschaftspraxis
Dresden, 01307
Düsseldorf, Universitätsklinikum, Klinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf, 40225
Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, 91054
Frankfurt, Universitätsklinikum, Klinik für Strahlentherapie und Onkologie
Frankfurt, 60590
Universitätsklinikum Regensburg
Regensburg, 93042
Universitätsklinikum Ulm
Ulm, 89075
About this study
Official title: First-line Treatment of Locally Advanced HNSCC With Double Checkpoint Blockade and Radiotherapy Dependent on Intratumoral CD8+ T Cell Infiltration (CheckRad-CD8, EudraCT NUMBER: 2017-003226-33)
First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.
Read the detailed description
This is a single arm, open-label, prospective, non-randomized Phase II clinical trial of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.
All patients will initially be treated with the PD-L1 inhibitor Durvalumab (1500 mg q4w) and the CTLA-4 Inhibitor Tremelimumab (75 mg q4w / since Amendment 3 (01.04.2020): 300 mg absolute dose d5) and one cycle with Cisplatin (30mg/m² d1-3) and Docetaxel (75mg/m² d1). Treatment response will be evaluated clinically by endoscopy with biopsy. Changes of the CD8+ T cell density in the second biopsy compared to the first one before therapy will be used for patient selection. Patients with a stable or decreased CD8+ tumor infiltrating immune cell density or clinical progressive disease will receive standard CRT outside the trial. For these patients toxicity will be monitored until the first dose of the subsequent standard CRT. Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w). The primary endpoint is feasibility. Feasibility criteria are receiving the protocol treatment until cycle 6 of antibody treatment and absence of any of the DLT defined in the protocol. A feasibility rate of ≥80% is expected. The efficacy of radioimmunotherapy and predictive character of changes of CD8+ tumor infiltrating immune cells after induction chemo-immunotherapy are further endpoints. The follow up period will be two years after the completion of radiotherapy.
- Being tested
- Durvalumab + Tremelimumab + RT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab + Tremelimumab + RTCombination product
Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w).
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + Tremelimumab + RT | Experimental | Durvalumab (1500 mg,q4W) + Tremelimumab (75 mg, q4W / since Amendment 3: 300 mg absolute dose d5) for up to a maximum of 4 doses/cycles combined with radiotherapy (35 x 2.0/1.8/1.6 Gy) followed by durvalumab monotherapy 1500mg via IV infusion q4W, starting 4 weeks after the last infusion of the combination, for up to a maximum of 8 additional durvalumab doses. Receives: Combination Product: Durvalumab + Tremelimumab + RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the number of participants receiving the protocol treatment until cycle 6 of antibody treatment
Feasibility means the number of participants receiving the protocol treatment
Measured: At the end of cycle 6 of antibody treatment (each cycle is 4 weeks)
Assessment of the predictive character of changes of CD8+ tumor infiltrating immune cells after induction chemo-immunotherapy
Changes of the CD8+ T cell density in the second biopsy compared to the first one before therapy will be used for patient selection.
Measured: At Baseline and week 4
Assessment of the absence of any dose-limiting toxicities
Feasibility means the number of dose-limiting toxicities of Grade 3 or higher toxicity that occurs during the trial
Measured: At the time of cycle 1 (week 2) to the last cycle 5-12 (up to 2 years)
Secondary outcomes (3)
Progression free survival
All patients will receive tumor imaging (CT or MRI) 12 weeks after completion of radiotherapy and panendoscopy with biopsy.
Measured: 12 weeks after completion of radiotherapy
Pathologically confirmed response
All patients will receive tumor imaging (CT or MRI) 12 weeks after completion of radiotherapy and panendoscopy with biopsy.
Measured: 12 weeks after completion of radiotherapy
Overall survival
All patients will receive tumor imaging (CT or MRI) 12 weeks after completion of radiotherapy and panendoscopy with biopsy.
Measured: 12 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start20 Sep 2018
- Primary completion16 Sep 2021
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Model description
- Prospective, Open-Label, Non-Randomized
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, Prof., Study chair, Universitätsklinikum Erlangen, StrahlenklinikWilfried Budach, Prof., Study chair, University DüsseldorfClaus Rödel, Prof., Study chair, Johann Wolfgang Goethe University HospitalMarkus Hecht, M.D., Principal investigator, University of Erlangen-NürnbergUdo Gaipl, Prof., Study chair, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426657
- Sponsor's protocol ID
- CheckRad-CD8
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beck M, Hartwich J, Eckstein M, Schmidt D, Gostian AO, Muller S, Rutzner S, Gaipl US, von der Grun J, Illmer T, Hautmann MG, Klautke G, Doscher J, Brunner T, Tamaskovics B, Hartmann A, Iro H, Kuwert T, Fietkau R, Hecht M, Semrau S. F18-FDG PET/CT imaging early predicts pathologic complete response to induction chemoimmunotherapy of locally advanced head and neck cancer: preliminary single-center analysis of the checkrad-cd8 trial. Ann Nucl Med. 2022 Jul;36(7):623-633. doi: 10.1007/s12149-022-01744-6. Epub 2022 May 10.
PubMed 35534690Hecht M, Eckstein M, Rutzner S, von der Grun J, Illmer T, Klautke G, Laban S, Hautmann MG, Brunner TB, Tamaskovics B, Hinke A, Zhou JG, Frey B, Donaubauer AJ, Becker I, Semrau S, Hartmann A, Balermpas P, Budach W, Gaipl US, Iro H, Gostian AO, Fietkau R. Induction chemoimmunotherapy followed by CD8+ immune cell-based patient selection for chemotherapy-free radioimmunotherapy in locally advanced head and neck cancer. J Immunother Cancer. 2022 Jan;10(1):e003747. doi: 10.1136/jitc-2021-003747.
PubMed 35078923
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Treatment of Locally Advanced HNSCC With Double Checkpoint Blockade and Radiotherapy Dependent on Intratumoral CD8+ T Cell Infiltration (CheckRad-CD8, EudraCT NUMBER: 2017-003226-33)
- ClinicalTrials.gov ID
- NCT03426657
- Acronym / sponsor ID
- CheckRad-CD8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 8 Feb 2018 (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.
First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.
Detailed description
This is a single arm, open-label, prospective, non-randomized Phase II clinical trial of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.
All patients will initially be treated with the PD-L1 inhibitor Durvalumab (1500 mg q4w) and the CTLA-4 Inhibitor Tremelimumab (75 mg q4w / since Amendment 3 (01.04.2020): 300 mg absolute dose d5) and one cycle with Cisplatin (30mg/m² d1-3) and Docetaxel (75mg/m² d1). Treatment response will be evaluated clinically by endoscopy with biopsy. Changes of the CD8+ T cell density in the second biopsy compared to the first one before therapy will be used for patient selection. Patients with a stable or decreased CD8+ tumor infiltrating immune cell density or clinical progressive disease will receive standard CRT outside the trial. For these patients toxicity will be monitored until the first dose of the subsequent standard CRT. Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w). The primary endpoint is feasibility. Feasibility criteria are receiving the protocol treatment until cycle 6 of antibody treatment and absence of any of the DLT defined in the protocol. A feasibility rate of ≥80% is expected. The efficacy of radioimmunotherapy and predictive character of changes of CD8+ tumor infiltrating immune cells after induction chemo-immunotherapy are further endpoints. The follow up period will be two years after the completion of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Open-Label, Non-Randomized
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + Tremelimumab + RT | Experimental | Combination Product: Durvalumab + Tremelimumab + RTDurvalumab (1500 mg,q4W) + Tremelimumab (75 mg, q4W / since Amendment 3: 300 mg absolute dose d5) for up to a maximum of 4 doses/cycles combined with radiotherapy (35 x 2.0/1.8/1.6 Gy) followed by durvalumab monotherapy 1500mg via IV infusion q4W, starting 4 weeks after the last infusion of the combination, for up to a maximum of 8 additional durvalumab doses. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening Evaluations.
- Age > 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)
- Locally advanced HNSCC, UICC stage III-IVB (oral cavity, oropharynx, hypopharynx, supraglottic larynx)
- Histological confirmation of HNSCC (regardless if p16 positive or negative)
Key exclusion criteria (36 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Participation in another clinical study with an investigational product during the last 4 weeks
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Distant metastases
- Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced HNSCC
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 |
|---|---|---|
| Durvalumab + Tremelimumab + RTPatients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w). | Combination product | Durvalumab + Tremelimumab + RT |
Primary outcome
Assessment of the number of participants receiving the protocol treatment until cycle 6 of antibody treatment
Time frame: At the end of cycle 6 of antibody treatment (each cycle is 4 weeks)
Feasibility means the number of participants receiving the protocol treatment
Assessment of the predictive character of changes of CD8+ tumor infiltrating immune cells after induction chemo-immunotherapy
Time frame: At Baseline and week 4
Changes of the CD8+ T cell density in the second biopsy compared to the first one before therapy will be used for patient selection.
Assessment of the absence of any dose-limiting toxicities
Time frame: At the time of cycle 1 (week 2) to the last cycle 5-12 (up to 2 years)
Feasibility means the number of dose-limiting toxicities of Grade 3 or higher toxicity that occurs during the trial
3 secondary outcomes
Progression free survival
Time frame: 12 weeks after completion of radiotherapy
Pathologically confirmed response
Time frame: 12 weeks after completion of radiotherapy
Overall survival
Time frame: 12 weeks after completion of radiotherapy
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 11 Apr 2024.
- Derived from this study: PubMed 35534690Beck M, Hartwich J, Eckstein M, Schmidt D, Gostian AO, Muller S, Rutzner S, Gaipl US, von der Grun J, Illmer T, Hautmann MG, Klautke G, Doscher J, Brunner T, Tamaskovics B, Hartmann A, Iro H, Kuwert T, Fietkau R, Hecht M, Semrau S. F18-FDG PET/CT imaging early predicts pathologic complete response to induction chemoimmunotherapy of locally advanced head and neck cancer: preliminary single-center analysis of the checkrad-cd8 trial. Ann Nucl Med. 2022 Jul;36(7):623-633. doi: 10.1007/s12149-022-01744-6. Epub 2022 May 10.
- Derived from this study: PubMed 35078923Hecht M, Eckstein M, Rutzner S, von der Grun J, Illmer T, Klautke G, Laban S, Hautmann MG, Brunner TB, Tamaskovics B, Hinke A, Zhou JG, Frey B, Donaubauer AJ, Becker I, Semrau S, Hartmann A, Balermpas P, Budach W, Gaipl US, Iro H, Gostian AO, Fietkau R. Induction chemoimmunotherapy followed by CD8+ immune cell-based patient selection for chemotherapy-free radioimmunotherapy in locally advanced head and neck cancer. J Immunother Cancer. 2022 Jan;10(1):e003747. doi: 10.1136/jitc-2021-003747.
- 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.
Rainer Fietkau, Prof. study chair
Universitätsklinikum Erlangen, Strahlenklinik
Wilfried Budach, Prof. study chair
University Düsseldorf
Claus Rödel, Prof. study chair
Johann Wolfgang Goethe University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab + Tremelimumab + RT in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by University of Erlangen-Nürnberg Medical School at 7 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 15 inclusion and 36 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 11 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 7 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?
Assessment of the number of participants receiving the protocol treatment until cycle 6 of antibody treatment (time frame: At the end of cycle 6 of antibody treatment (each cycle is 4 weeks)). The study lists 3 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 NCT03426657, 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 11 Apr 2024.