Head and Neck Cancer, Squamous Cell Cancer
Conditions
Brief summary
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Interventions
DRUGZalutumumab
Individual dose titration weekly i.v. doses
Sponsors
Genmab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females age ≥ 18 years 2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. Failure to at least one course of standard platinum-based chemotherapy
Exclusion criteria
1. Three or more prior chemotherapy regimens 2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors 3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization until death, assessed up to 21 months | OS was defined as time from start of treatment until date of death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | During treatment and two weeks after end of treatment, assessed up to 21 months | PFS is defined as the time from start of treatment until disease progression or death. |
| Objective Tumour Response | During treatment and two weeks after end of treatment, assessed up to 21 months. | Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions. |
| Duration of Response | During treatment and two weeks after end of treatment, assessed up to 21 months | DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier. |
Countries
Austria, Chile, Colombia, Czechia, Germany, Israel, Italy, Peru, Portugal, Slovakia, United States
Participant flow
Pre-assignment details
All participants attending Visit 2 were included in the FAS irrespective of their compliance with the planned course of zalutumumab.
Participants by arm
| Arm | Count |
|---|---|
| Zalutumumab 4-16 mg/kg Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Zalutumumab 4-16 mg/kg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 59.1 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Austria | 3 participants |
| Region of Enrollment Chile | 8 participants |
| Region of Enrollment Colombia | 1 participants |
| Region of Enrollment Czech Republic | 6 participants |
| Region of Enrollment Germany | 11 participants |
| Region of Enrollment Israel | 12 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment Peru | 4 participants |
| Region of Enrollment Portugal | 10 participants |
| Region of Enrollment Slovakia | 4 participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 90 / 90 |
| serious Total, serious adverse events | 83 / 90 |
Outcome results
Primary
Overall Survival (OS)
OS was defined as time from start of treatment until date of death of any cause.
Time frame: From randomization until death, assessed up to 21 months
Population: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zalutumumab 4-16 mg/kg | Overall Survival (OS) | 5.3 months |
Secondary
Duration of Response
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
Population: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are the number of participants with a response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zalutumumab 4-16 mg/kg | Duration of Response | NA days |
Secondary
Objective Tumour Response
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months.
Population: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are number of participants with data available for analysis of best response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zalutumumab 4-16 mg/kg | Objective Tumour Response | Complete response | 1 participants |
| Zalutumumab 4-16 mg/kg | Objective Tumour Response | Partial response | 4 participants |
| Zalutumumab 4-16 mg/kg | Objective Tumour Response | Stable response | 30 participants |
| Zalutumumab 4-16 mg/kg | Objective Tumour Response | Progressive disease | 33 participants |
| Zalutumumab 4-16 mg/kg | Objective Tumour Response | Not evaluable | 20 participants |
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from start of treatment until disease progression or death.
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
Population: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zalutumumab 4-16 mg/kg | Progression Free Survival (PFS) | 8.6 months |