A Phase 2 interventional study of Telisotuzumab Adizutecan and Pembrolizumab in Head and Neck Squamous Cell Carcinoma, sponsored by AbbVie. Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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Among 14 studies in Squamous Cell Carcinoma of Head and Neck by AbbVie — 5 open to participants now, 7 under way, none of them phase 3. Squamous Cell Carcinoma of Head and Neck · AbbVie.
Among the 14 studies in Squamous Cell Carcinoma of Head and Neck by AbbVie, this one is the 6th largest by planned enrollment, is one of 2 that started in 2026, is the only one in phase 2, and was the 13th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →5 of the 14 studies in Squamous Cell Carcinoma of Head and Neck by AbbVie are open now, in 9 countries. Recruiting first, the newest first:
AbbVie · Sites in United States
Ages 18+
AbbVie · Sites in United States, Canada, Israel and 1 more country
Ages 18+
AbbVie · Sites in United States, Australia, Israel and 5 more countries
Ages 18+
AbbVie · Sites in United States, Canada, Israel and 3 more countries
Ages 18+
By country, each count listing its studies:
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 116 across the 14 interventional studies. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
AbbVie is the lead sponsor of 977 studies on the registry; 136 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 215 (60%) have results posted.
3 of the studies in Squamous Cell Carcinoma of Head and Neck by AbbVie that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03821935AbbVieStudy to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors | 2027-06 |
| NCT05005403AbbVieStudy to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan | 2027-07 |
| NCT06084481AbbVieStudy to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 14 studies in Squamous Cell Carcinoma of Head and Neck by AbbVie, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide.
Participants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 67 weeks study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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.
Exclusion Criteria:
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 67 weeks study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 67 weeks study duration.
Drug: Pembrolizumab · Drug: Carboplatin · Drug: Cisplatin · Drug: Fluorouracil
Intravenous (IV)
IV
IV
IV
IV
Number of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 67 weeks
Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to Approximately 67 weeks
Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: Up to Approximately 67 weeks
Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
DoR is defined as the time from the first objective response (complete response or partial response) to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: Up to Approximately 67 weeks
Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
DC is defined as subjects achieving a best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on BICR assessment per RECIST v1.1.
Time frame: Up to Approximately 67 weeks
OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
OR based on investigator assessment is defined as participants achieving a best overall response of confirmed CR or confirmed PR based on investigator assessment.
Time frame: Up to Approximately 67 weeks
PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS is defined as the time from date of randomization to the first documentation of radiographic progressive disease (PD) based on investigator assessment or death from any cause, whichever occurs first.
Time frame: Up to Approximately 67 weeks
DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
DoR based on investigator assessment is defined as the time from the initial response of confirmed CR or confirmed PR based on investigator assessment to radiographic PD based on investigator assessment, or death of any cause, whichever occurs first.
Time frame: Up to Approximately 67 weeks
DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
DC based on investigator assessment is defined as subjects achieving a best overall response of confirmed CR or confirmed PR, or SD based on investigator assessment.
Time frame: Up to Approximately 67 weeks
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to Approximately 67 weeks
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Oct 2029, 37 months after the start.
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 planned 37 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Telisotuzumab adizutecan
Squamous Cell Carcinoma of Head and Neck →