A Phase 2 interventional study of Tislelizumab and BGB-A425 in Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, sponsored by BeiGene. Completed at 73 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience.
Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals.
The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 160 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 55 completed or terminated interventional studies of FDA-regulated products, 32 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with or cytologically confirmed R/M HNSCC that is considered incurable by local therapies
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
Drug: Tislelizumab
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
Drug: Tislelizumab · Drug: BGB-A425
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
Drug: Tislelizumab · Drug: LBL-007
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
Drug: Tislelizumab · Drug: BGB-A425 · Drug: LBL-007
Administered intravenously
Also known as: BGB-A317
Administered intravenously
Also known as: Surzebiclimab
Administered intravenously
Also known as: Alcestobart
Objective Response Rate (ORR)
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.
Time frame: Up to 21.2 months
Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) assessed by the investigators per RECIST v1.1 or death, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.
Time frame: Up to 21.2 months
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurred first.
Time frame: Up to 21.2 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or durable stable disease (SD) (SD duration ≥ 24 weeks). SD is defined as neither sufficient decrease in size of target lesions to qualify for PR nor sufficient increase to qualify for PD, no progressive disease in nontarget lesions, and no new lesions.
Time frame: Up to 21.2 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD.
Time frame: Up to 21.2 months
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with adverse events (AEs), including laboratory values, vital signs, physical examinations, and electrocardiogram findings. AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being least severe and Grade 5 being most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was considered a significant medical AE by the investigator based on medical judgement.
Time frame: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to 21.2 months
Participants were enrolled at 57 centers in 13 countries globally. The main part of the study completed on 17 June 2025. At that time, participants who continued to receive clinical benefit were offered continued access to study treatment in the Extended Access Period. Results are reported up to the data cut-off date of 17 June 2025.
| Milestone | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Started | 40 | 40 | 40 | 40 |
| Received treatment | 40 | 39 | 40 | 40 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 40 | 40 | 40 | 40 |
| Withdrew: Death | 19 | 16 | 20 | 19 |
| Withdrew: Main study closed by sponsor | 3 | 7 | 5 | 6 |
| Withdrew: Lost to follow-up | 1 | 3 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 1 |
| Withdrew: Participant not eligible | 0 | 1 | 1 | 0 |
| Withdrew: Remaining on study | 16 | 11 | 13 | 13 |
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.
| Percentage of Participants | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Objective Response Rate (ORR) | 27.5 (14.6 to 43.9) | 27.5 (14.6 to 43.9) | 25.0 (12.7 to 41.2) | 27.5 (14.6 to 43.9) |
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) assessed by the investigators per RECIST v1.1 or death, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.
| months | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Progression-free Survival (PFS) | 2.6 (1.4 to 6.4) | 5.4 (2.8 to 6.9) | 3.4 (1.6 to 5.8) | 4.1 (3.0 to 5.6) |
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurred first.
| months | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Duration of Response (DOR) | 8.2 (3.9 to NA) | NA (2.6 to NA) | NA (8.4 to NA) | NA (3.4 to NA) |
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or durable stable disease (SD) (SD duration ≥ 24 weeks). SD is defined as neither sufficient decrease in size of target lesions to qualify for PR nor sufficient increase to qualify for PD, no progressive disease in nontarget lesions, and no new lesions.
| Percentage of Participants | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Clinical Benefit Rate (CBR) | 32.5 (18.6 to 49.1) | 37.5 (22.7 to 54.2) | 35.0 (20.6 to 51.7) | 37.5 (22.7 to 54.2) |
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD.
| Percentage of Participants | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Disease Control Rate (DCR) | 55.0 (38.5 to 70.7) | 67.5 (50.9 to 81.4) | 62.5 (45.8 to 77.3) | 65.0 (48.3 to 79.4) |
Number of participants with adverse events (AEs), including laboratory values, vital signs, physical examinations, and electrocardiogram findings. AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being least severe and Grade 5 being most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was considered a significant medical AE by the investigator based on medical judgement.
| Participants | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Participants with any Treatment-Emergent Adverse Event (TEAE) | 37 | 34 | 39 | 40 |
| Participants with a TEAE of Grade 3 or Higher | 21 | 15 | 14 | 23 |
| Participants with a Serious TEAE | 17 | 14 | 11 | 16 |
OS is defined as the time from the date of randomization to the date of death due to any cause.
| Months | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| Overall Survival (OS) | NA (6.6 to NA) | 18.3 (10.5 to NA) | 14.9 (9.9 to NA) | 14.4 (7.7 to NA) |
Collected over AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tislelizumab | 19/40 (47.5%) | 17/40 (42.5%) | 36/40 (90%) |
| Tislelizumab + Surzebiclimab | 16/40 (40%) | 14/39 (35.9%) | 32/39 (82.1%) |
| Tislelizumab + Alcestobart | 20/40 (50%) | 11/40 (27.5%) | 37/40 (92.5%) |
| Tislelizumab + Surzebiclimab + Alcestobart | 19/40 (47.5%) | 16/40 (40%) | 39/40 (97.5%) |
| Event | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 3/40 | 4/39 | 3/40 | 2/40 |
| Mouth haemorrhageGastrointestinal disorders | 3/40 | 0/39 | 0/40 | 0/40 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/40 | 2/39 | 0/40 | 1/40 |
| Pneumonia aspirationInfections and infestations | 0/40 | 0/39 | 2/40 | 1/40 |
| Alanine aminotransferase increasedInvestigations | 0/40 | 0/39 | 0/40 | 2/40 |
| Aspartate aminotransferase increasedInvestigations | 0/40 | 0/39 | 0/40 | 2/40 |
| GlossodyniaGastrointestinal disorders | 0/40 | 1/39 | 0/40 | 0/40 |
| Mouth swellingGastrointestinal disorders | 0/40 | 1/39 | 0/40 | 0/40 |
| Sudden deathGeneral disorders | 0/40 | 1/39 | 0/40 | 0/40 |
| Lower respiratory tract infectionInfections and infestations | 0/40 | 1/39 | 0/40 | 0/40 |
| Event | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 8/40 | 8/39 | 6/40 | 15/40 |
| HypothyroidismEndocrine disorders | 2/40 | 6/39 | 13/40 | 8/40 |
| PruritusSkin and subcutaneous tissue disorders | 4/40 | 3/39 | 9/40 | 6/40 |
| FatigueGeneral disorders | 5/40 | 4/39 | 3/40 | 8/40 |
| ConstipationGastrointestinal disorders | 5/40 | 4/39 | 7/40 | 3/40 |
| DiarrhoeaGastrointestinal disorders | 5/40 | 5/39 | 3/40 | 7/40 |
| Decreased appetiteMetabolism and nutrition disorders | 7/40 | 4/39 | 1/40 | 6/40 |
| Aspartate aminotransferase increasedInvestigations | 6/40 | 6/39 | 5/40 | 5/40 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 2/40 | 6/39 | 3/40 | 4/40 |
| HyponatraemiaMetabolism and nutrition disorders | 2/40 | 6/39 | 4/40 | 4/40 |
| Age, Categorical(Participants) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 25 | 18 | 18 | 85 |
| >=65 years | 16 | 15 | 22 | 22 | 75 |
| Age, Continuous(years) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| Mean | 61.5 ± 10.49 | 62.7 ± 10.42 | 63.2 ± 12.31 | 63.8 ± 11.20 | 62.8 ± 11.06 |
| Sex: Female, Male(Participants) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| Female | 7 | 5 | 6 | 7 | 25 |
| Male | 33 | 35 | 34 | 33 | 135 |
| Race/Ethnicity, Customized(Participants) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| Race — Asian | 23 | 31 | 28 | 31 | 113 |
| Race — White | 16 | 9 | 12 | 8 | 45 |
| Race — Not Reported | 0 | 0 | 0 | 1 | 1 |
| Race — Missing | 1 | 0 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| Ethnicity — Not Hispanic or Latino | 36 | 39 | 39 | 37 | 151 |
| Ethnicity — Hispanic or Latino | 2 | 0 | 1 | 0 | 3 |
| Ethnicity — Not Reported | 1 | 0 | 0 | 2 | 3 |
| Ethnicity — Unknown | 0 | 1 | 0 | 1 | 2 |
| Ethnicity — Missing | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Tislelizumab | Tislelizumab + Surzebiclimab | Tislelizumab + Alcestobart | Tislelizumab + Surzebiclimab + Alcestobart | Total |
|---|---|---|---|---|---|
| China | 8 | 12 | 14 | 12 | 46 |
| South Korea | 5 | 10 | 6 | 5 | 26 |
| Taiwan | 4 | 7 | 6 | 7 | 24 |
| Thailand | 6 | 2 | 2 | 5 | 15 |
| United States | 1 | 3 | 1 | 4 | 9 |
| Australia | 3 | 1 | 3 | 1 | 8 |
| Georgia | 2 | 4 | 2 | 0 | 8 |
| Italy | 3 | 0 | 2 | 2 | 7 |
| Spain | 3 | 0 | 3 | 1 | 7 |
| France | 2 | 0 | 1 | 2 | 5 |
| United Kingdom | 2 | 1 | 0 | 0 | 3 |
| Canada | 0 | 0 | 0 | 1 | 1 |
| Turkey (Türkiye) | 1 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beigene.com
Ran from Aug 2023 to primary completion in Jun 2025, 22 months.
Results were first posted in Jul 2026, 1 year after primary completion.
Of 68 industry-sponsored phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 60. This study's 22 months is below that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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