Phase 2
N=35
Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Cancer · Head and Neck Cancer · Head and Neck Neoplasms · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03691714 ↗Enrolled (actual)
35
Serious AEs
68.6%
Results posted
Jun 2026
Primary outcome: Primary: Objective Response Rate — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Durvalumab (Drug); Cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trisha Wise-Draper
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
13 | — |
| SECONDARY Treatment Related Adverse Events |
9 | — |
| SECONDARY Disease Control Rate |
20 | — |
| SECONDARY Progression-free Survival |
5.8 | — |
| SECONDARY Overall Survival |
9.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03691714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.