Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer, Recurrent Head and Neck Cancer
Conditions
Brief summary
The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.
Detailed description
This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.
Interventions
DRUGDurvalumab
Two hour infusion
DRUGCetuximab
Two hour infusion for loading dose followed by weekly one hour infusion
Sponsors
University of Cincinnati
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body weight \> 30 kg * Histologically or cytologically confirmed recurrent or metastatic HNSCC * Not considered a candidate for other curative therapy (i.e. surgery/RT) * Documented progression of disease after receiving platinum based regimen * ECOG performance status 0-2
Exclusion criteria
* Nasopharyngeal and salivary gland tumors * Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Related Adverse Events | From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months. | Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab). |
| Disease Control Rate | 6 months | Combined complete response, partial response, and stable disease |
| Progression-free Survival | 24 months | Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Overall Survival | 24 months | Date of on treatment to date of death |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrisha Wise-Draper, MD
University of Cincinnati
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 years |
| ECOG Status 0 = Fully active; no restrictions | 6 Participants |
| ECOG Status 1 = Restricted in strenuous activity but ambulatory | 22 Participants |
| ECOG Status 2 = Ambulatory, capable of self-care, unable to work | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 35 |
| other Total, other adverse events | 35 / 35 |
| serious Total, serious adverse events | 24 / 35 |
Outcome results
None listed