Description:
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.
Title
- Brief Title: Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Official Title: An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Clinical Trial IDs
- ORG STUDY ID:
UCCI-HN-17-02
- SECONDARY ID:
EAR-17-12765
- NCT ID:
NCT03691714
Conditions
- Recurrent Head and Neck Cancer
- Head and Neck Cancer
- Head and Neck Neoplasms
- Metastatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Durvalumab and Cetuximab |
Cetuximab | | Durvalumab and Cetuximab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Durvalumab and Cetuximab | Experimental | Durvalumab 1500mg IV every 4 weeks Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues for a maximum of 24 months while Cetuximab may continue as maintenance | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Imaging review using RECIST 1.1 |
Secondary Outcome Measures
Measure: | Adverse events |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Percentage of adverse events using CTCAE v 5.0 |
Measure: | Disease control rate |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Combined complete response, partial response, and stable disease |
Measure: | Progression-free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Imaging review using RECIST 1.1 |
Measure: | Overall survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Date of on treatment to date of death |
Measure: | Duration of response |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Date of initial response to progressive disease |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Shuchi Gulati |
Last Updated
March 4, 2021