Status:
COMPLETED
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
Lead Sponsor:
MedImmune LLC
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combinati...
Eligibility Criteria
Inclusion
- Male and female subjects
- 18 years and older
- Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
- Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
- Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.
Exclusion
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
- Concurrent or prior use of immunosuppressive medication within 14 days
- Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02262741
Start Date
October 15 2014
End Date
September 21 2017
Last Update
October 23 2017
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Scottsdale, Arizona, United States, 85258
2
Research Site
La Jolla, California, United States, 92093
3
Research Site
Los Angeles, California, United States, 90025
4
Research Site
Los Angeles, California, United States, 90095