Squamous Cell Carcinoma of Head and NeckPhase 2ICINGNCT04428047
Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing bintrafusp alfa in people with Squamous Cell Carcinoma of Head and Neck, run by UNICANCER at 8 sites in France.
Trial summary
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial. This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity… 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?
- bintrafusp alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesFrance
- Study dates
- 4 Feb 2021to 7 Jan 2022
- 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
- Age ≥18 years
- Patients must have signed a written informed consent form prior to any trial specific procedures
- Histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of HNSCC of occult primary could not be enrolled.
- In order to avoid repeated biopsies procedures under general anesthesia, patients with clinically highly suspected squamous cell carcinoma could be registered before the histological or cytological proof. In these cases, the diagnosis will be confirmed rapidly after the endoscopy, either by using frozen sections or by reporting the results obtained on formalin-fixed paraffin-embedded (FFPE) within no more than 5 working days.
- Absence of distant metastases determined by CT-scan or PET-CT that must be performed within 35 days prior to endoscopy.
- According to the 7th edition American Joint Committee on Cancer (AJCC) eligible stages are as follow:
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- T2N1, T2N2, T2N3 T3 or T4 (any N)
- Baseline radiology studies evaluating primary tumor (MRI or CT-scan) must be performed within 28 days prior to endoscopy.
- Patients must have at least 1 lesion superior to 2 cm in larger axis
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate organ and marrow function as defined by the following laboratory results obtained within 28 days prior to the baseline endoscopy:
- Hemoglobin (Hb) ≥9,0 g/dL;
- Absolute neutrophil count (ANC) ≥1,500/mm³;
- Platelet count ≥100,000/mm³;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × institutional upper limit of normal (ULN);
- Total bilirubin ≤1.5 × ULN;
- Creatinine clearance >30 mL/min as determined by the Cockcroft-Gault equation (Cockcroft and Gault, 1976)
- Negative serology for hepatitis B and C
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Willing and able to provide tumor specimen and blood samples for translational research.
- Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment.
- Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 2 months after last dose of study drugs.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Patients must be affiliated to the social security system or equivalent
Who cannot join
- Primary site of head and neck carcinoma in nasopharynx, sinuses, or skin
- Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other gonadotropin releasing hormone (GnRH) agonists) or other investigational agent within 6 months prior to the first dose of study drug and while on study treatment.
- Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 6 months prior to the first dose of study drug and while on study treatment.
- Previous or concurrent cancer within 2 years prior to study inclusion including symptomatic, untreated, or actively progressing central nervous system (CNS) metastases, with the exception of the following cancer types: in situ carcinomas of any location; skin basal cell carcinoma stage T1N0M0 or T2N0M0
- Any previous treatment with a PD-1, PD-L1 agent
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses.
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- Current or prior use of immunosuppressive medication within 28 days before the first dose of bintrafusp alfa, with the exceptions of intranasal, intraocular and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
- Receipt of live attenuated vaccination within 28 days prior to the first administration of bintrafusp alfa.
- History of (non-infectious) pneumonitis that required steroids within 28 days prior to the first administration of bintrafusp alfa or current pneumonitis.
- Major surgery within 28 days prior to the first administration of bintrafusp alfa and not recovered adequately from the toxicities and/or complications.
- Serious, non-healing or dehiscing, wound, active ulcer, or ongoing bone fracture.
- Active or prior documented autoimmune disease within the past 2 years. Note: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) can be enrolled
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency
- History of allogenic organ transplant that requires the use of immunosuppressive drugs
- Pregnant or breast-feeding women
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Known positive HIV status
- Participation in another clinical study with an investigational product during the last 28 days.
- Known hypersensitivity to the study drug, study drug classes, or study drug excipients.
- Patients under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g., psychiatric illness/social/familial/geographical condition) that would limit compliance with study requirement or compromise the ability of the patients to give written informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Bordeaux
Bordeaux
Centre Antoine Lacassagne
Cagnes-sur-Mer
Centre Léon Bérard
Lyon
CHU La Timone
Marseille
Institut Curie
Paris
Institut Claudius Régaud
Toulouse
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy
Gustave Roussy Cancer Campus
Villejuif
About this study
Official title: A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial.
This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.
Read the detailed description
The study plans to enrol up to 59 patients in total. Eligible patients who have provided their written informed consent for study participation will be assigned to one the 2 cohorts described below:
Cohort A (43 patients): Non-oropharyngeal HNSCC, or Oropharyngeal squamous cell carcinoma (SCC) that are human papillomavirus (HPV) negative, or Oropharyngeal SCC that are HPV positive and smoker ≥20 pack year (PY).
A Minimax two-stage Simon design will be used with an unacceptable rate of pathological response of 30% or less and a hypothesized actual pathological response rate of 50% or more.
In the first stage, 28 patients will be accrued. If the observed number of patients with a pathological response is 7 or less, then the study for the cohort A will conclude to inefficacy and patient recruitment in this cohort will be stopped.
Cohort B (16 patients): Oropharyngeal SCC that are HPV positive and non-smoker or smoker <20 PY (former or active).
The design for this cohort will be a single-stage design.
All trial-related interventions will be strictly similar for these 2 cohorts.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- bintrafusp alfa
- Keywords
- PDL1 blockade, TGFb trap, PathR, window-of-opportunity preoperative trial
- 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.
bintrafusp alfaDrug
Also called M7824
bintrafusp alfa will be administered by intravenous infusion over 60 minutes at a dose of 1200 mg on Day1 and Day15
| Study group | Role | What they receive |
|---|---|---|
| bintrafusp alfa | Experimental | bintrafusp alfa will be administered by intravenous infusion over 60 minutes at a dose of 1200 mg on Day1 and Day15 Receives: Drug: bintrafusp alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response (PathR)
Pathological tumor response will be evaluated as the percentage of the tumor area showing evidence of anti-tumor activity, such as tumor cell necrosis and/or giant cell/histolytic reaction to keratinous debris
Measured: From inclusion to 1 month after surgery
Secondary outcomes (10)
Pathological response using a threshold of 50% (PathR50), 70% (PathR70) and 90% (PathR90)
Will be considered as responders, the patients presenting 50% or more, 70% or more, and 90% or more, respectively, of tumor cell death.
Measured: From inclusion to 1 month after surgery
Response rate, using primary endpoint criteria, by PD-L1 status
The response rate using primary endpoint criteria, by PD-L1 status using Combined Positive Score (CPS) thresholds of 1 and 20. CPS is the number of PD-L1 staining cells (tumor cells and immune cells) divided by the total number of viable tumor cells, multiplied by 100.
Measured: 3 years
Response rate, using primary endpoint criteria, by HPV status in cohort A
The response rate, using primary endpoint criteria, by HPV status determined by p16 staining in cohort A. Two categories will be defined: HPV- and HPV+ (smokers ≥20 PY). HPV+ non-smoker or smoker <20 PY will be included in cohort B.
Measured: 2 years
Clinical response
Efficacy of bintrafusp alfa by clinical response will be evaluated by measuring changes in tumor size in response to treatment; measured by Magnetic resonance Imaging (MRI) or positron emission tomography (PET) scan and assessed by RECIST v1.1
Measured: From inclusion to post-treatment imaging visit, an average of 21 days
Disease-free survival (DFS)
DFS defined as the delay between the date of the surgery and the occurrence of a loco-regional recurrence and/or a distant metastasis due to the cancer or death whatever the cause for which the patient was included, whichever comes first.
Measured: 12, 18, 24, and 36 months after surgery
Overall survival (OS)
OS defined as the delay between the date of the surgery and the occurrence of death, whatever the cause.
Measured: 12, 18, 24, and 36 months after surgery
Loco-regional disease-free survival (LR-DFS)
LR-DFS defined as the delay between the date of the surgery and the first occurrence of a loco-regional recurrence due to the cancer or death whatever the cause for which the patient was included.
Measured: 12, 18, 24, and 36 months after surgery
Distant disease-free survival (D-DFS)
D-DFS defined as the delay between the date of the surgery and the first occurrence of a distant metastasis due to the cancer or death whatever the cause for which the patient was included.
Measured: 12, 18, 24, and 36 months after surgery
Treatment-Emergent Adverse Events (Safety and Tolerability) profile of bintrafusp alfa
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.
Measured: From inclusion to 12 weeks after the last administration of the investigational product
Evaluation of the impact of inking the tumor margins during baseline endoscopy to avoid surgical plan changes putatively induced by tumor shrinking under therapy
Just before the beginning of the surgery, surgeons will answer a question (4-level: Yes, No, Not evaluable, Unknown) to indicate if their surgical plan would have been different in the absence of ink labelling.
Measured: From inclusion to surgery, an average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start4 Feb 2021
- Primary completion4 Sep 2021
- Study completion7 Jan 2022
Why it stopped: Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies
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 Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Caroline Hoffmann, MD, PhD, Principal investigator, Institut CurieChristophe Letrouneau, MD, PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428047
- Sponsor's protocol ID
- UC-HNG/1909
- Other IDs
- 2019-004052-11, 2019
- Acronym
- ICING
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Publications
Hoffmann C, Werle JT, Sirven P, Andrianteranagna M, Gal J, Lassoued W, Klijanienko J, Mesple J, Demaille B, Abbas A, Gauthier V, Borgman KJ, Puisieux I, Janho Dit Hreich S, Choussy O, Marret G, Lameiras S, Badois N, Dubray-Vautrin A, Dolivet G, Geoffrois L, Leclere R, Zeitouni W, Robil N, Merlevede J, Zhubanchaliyev A, Kamal M, Bieche I, Monard L, Simon C, Louis D, Allen CT, Rajan A, Gulley JL, Guillot-Delost M, Le Tourneau C, Salmon H. Neoadjuvant PD-L1/TGF-beta blockade can rapidly disrupt the tumor stroma in head and neck cancer patients. J Clin Invest. 2026 Nov 2;136(21):e198718. doi: 10.1172/JCI198718. eCollection 2026 Nov 2.
PubMed 42969228Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730.
PubMed 33720067
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04428047
- Acronym / sponsor ID
- ICING / UC-HNG/1909
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- PDL1 blockade, TGFb trap, PathR, window-of-opportunity preoperative trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies
- Enrolment
- 7 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 11 Jun 2020 (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.
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial.
This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.
Detailed description
The study plans to enrol up to 59 patients in total. Eligible patients who have provided their written informed consent for study participation will be assigned to one the 2 cohorts described below:
Cohort A (43 patients): Non-oropharyngeal HNSCC, or Oropharyngeal squamous cell carcinoma (SCC) that are human papillomavirus (HPV) negative, or Oropharyngeal SCC that are HPV positive and smoker ≥20 pack year (PY).
A Minimax two-stage Simon design will be used with an unacceptable rate of pathological response of 30% or less and a hypothesized actual pathological response rate of 50% or more.
In the first stage, 28 patients will be accrued. If the observed number of patients with a pathological response is 7 or less, then the study for the cohort A will conclude to inefficacy and patient recruitment in this cohort will be stopped.
Cohort B (16 patients): Oropharyngeal SCC that are HPV positive and non-smoker or smoker <20 PY (former or active).
The design for this cohort will be a single-stage design.
All trial-related interventions will be strictly similar for these 2 cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bintrafusp alfa | Experimental | Drug: bintrafusp alfabintrafusp alfa will be administered by intravenous infusion over 60 minutes at a dose of 1200 mg on Day1 and Day15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥18 years
- Patients must have signed a written informed consent form prior to any trial specific procedures
- Histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of HNSCC of occult primary could not be enrolled.
- In order to avoid repeated biopsies procedures under general anesthesia, patients with clinically highly suspected squamous cell carcinoma could be registered before the histological or cytological proof. In these cases, the diagnosis will be confirmed rapidly after the endoscopy, either by using frozen sections or by reporting the results obtained on formalin-fixed paraffin-embedded (FFPE) within no more than 5 working days.
- Absence of distant metastases determined by CT-scan or PET-CT that must be performed within 35 days prior to endoscopy.
Key exclusion criteria (21 listed)
- Primary site of head and neck carcinoma in nasopharynx, sinuses, or skin
- Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other gonadotropin releasing hormone (GnRH) agonists) or other investigational agent within 6 months prior to the first dose of study drug and while on study treatment.
- Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 6 months prior to the first dose of study drug and while on study treatment.
- Previous or concurrent cancer within 2 years prior to study inclusion including symptomatic, untreated, or actively progressing central nervous system (CNS) metastases, with the exception of the following cancer types: in situ carcinomas of any location; skin basal cell carcinoma stage T1N0M0 or T2N0M0
- Any previous treatment with a PD-1, PD-L1 agent
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 |
|---|---|---|
| bintrafusp alfaAlso: M7824bintrafusp alfa will be administered by intravenous infusion over 60 minutes at a dose of 1200 mg on Day1 and Day15 | Drug | bintrafusp alfa |
Primary outcome
Pathological response (PathR)
Time frame: From inclusion to 1 month after surgery
Pathological tumor response will be evaluated as the percentage of the tumor area showing evidence of anti-tumor activity, such as tumor cell necrosis and/or giant cell/histolytic reaction to keratinous debris
10 secondary outcomes
Pathological response using a threshold of 50% (PathR50), 70% (PathR70) and 90% (PathR90)
Time frame: From inclusion to 1 month after surgery
Response rate, using primary endpoint criteria, by PD-L1 status
Time frame: 3 years
Response rate, using primary endpoint criteria, by HPV status in cohort A
Time frame: 2 years
Clinical response
Time frame: From inclusion to post-treatment imaging visit, an average of 21 days
Disease-free survival (DFS)
Time frame: 12, 18, 24, and 36 months after surgery
Overall survival (OS)
Time frame: 12, 18, 24, and 36 months after surgery
Loco-regional disease-free survival (LR-DFS)
Time frame: 12, 18, 24, and 36 months after surgery
Distant disease-free survival (D-DFS)
Time frame: 12, 18, 24, and 36 months after surgery
Treatment-Emergent Adverse Events (Safety and Tolerability) profile of bintrafusp alfa
Time frame: From inclusion to 12 weeks after the last administration of the investigational product
Evaluation of the impact of inking the tumor margins during baseline endoscopy to avoid surgical plan changes putatively induced by tumor shrinking under therapy
Time frame: From inclusion to surgery, an average of 21 days
Results and safety
The study was stopped early (reason given: Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 42969228Hoffmann C, Werle JT, Sirven P, Andrianteranagna M, Gal J, Lassoued W, Klijanienko J, Mesple J, Demaille B, Abbas A, Gauthier V, Borgman KJ, Puisieux I, Janho Dit Hreich S, Choussy O, Marret G, Lameiras S, Badois N, Dubray-Vautrin A, Dolivet G, Geoffrois L, Leclere R, Zeitouni W, Robil N, Merlevede J, Zhubanchaliyev A, Kamal M, Bieche I, Monard L, Simon C, Louis D, Allen CT, Rajan A, Gulley JL, Guillot-Delost M, Le Tourneau C, Salmon H. Neoadjuvant PD-L1/TGF-beta blockade can rapidly disrupt the tumor stroma in head and neck cancer patients. J Clin Invest. 2026 Nov 2;136(21):e198718. doi: 10.1172/JCI198718. eCollection 2026 Nov 2.
- Derived from this study: PubMed 33720067Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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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.
Caroline Hoffmann, MD, PhD principal investigator
Institut Curie
Christophe Letrouneau, MD, PhD principal investigator
Institut Curie
8 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 bintrafusp alfa in people with Squamous Cell Carcinoma of Head and Neck, run by UNICANCER at 8 sites in France.
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 24 inclusion and 21 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: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 was stopped early (reason given: Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies). Results are not available in the source record.
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?
Pathological response (PathR) (time frame: From inclusion to 1 month after surgery). 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 NCT04428047, 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 6 Apr 2022.