Squamous Cell Carcinoma of the Head and Neck
Conditions
Brief summary
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.
Interventions
DRUGpembrolizumab
DRUGAcalabrutinib
Sponsors
Merck Sharp & Dohme LLC
Acerta Pharma BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women ≥ 18 years of age * Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy * Presence of radiographically measurable disease as defined by RECIST 1.1 * ECOG performance status of 0 or 1
Exclusion criteria
* Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years * Known central nervous system metastases and/or carcinomatous meningitis * A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Response | 52 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mono Therapy Arm - Pembrolizumab Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). | 39 |
| Combo Therapy Arm - Acalabrutinib + Pembrolizumab Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). | 37 |
| Total | 76 |
Baseline characteristics
| Characteristic | Mono Therapy Arm - Pembrolizumab | Total | Combo Therapy Arm - Acalabrutinib + Pembrolizumab |
|---|---|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 10.45 | 61.8 Years STANDARD_DEVIATION 10.71 | 61.4 Years STANDARD_DEVIATION 11.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 70 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 66 Participants | 29 Participants |
| Region of Enrollment United States | 39 Participants | 76 Participants | 37 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 34 Participants | 69 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 26 / 39 | 23 / 37 |
| other Total, other adverse events | 39 / 39 | 37 / 37 |
| serious Total, serious adverse events | 12 / 39 | 25 / 37 |
Outcome results
Primary
Number of Participants With Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 52 weeks
Population: The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.~And some of the participants didn't make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mono Therapy Arm - Pembrolizumab | Number of Participants With Overall Response | 7 Participants |
| Combo Therapy Arm - Acalabrutinib and Pembrolizumab | Number of Participants With Overall Response | 5 Participants |