Description:
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 combination with tremelimumab in subjects with recurrent/metastatic squamous cell
carcinoma of the head and neck.
Title
- Brief Title: A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
- Official Title: A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Clinical Trial IDs
- ORG STUDY ID:
D4190C00011
- NCT ID:
NCT02262741
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
Drug | Synonyms | Arms |
---|
MEDI4736 | | MEDI4736 + tremelimumab |
tremelimumab | | MEDI4736 + tremelimumab |
Purpose
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 combination with tremelimumab in subjects with recurrent/metastatic squamous cell
carcinoma of the head and neck.
Trial Arms
Name | Type | Description | Interventions |
---|
MEDI4736 + tremelimumab | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects
2. 18 years and older
3. 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.
4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1
required) in the recurrent/metastatic setting.
5. Subject eligibility will be based on PD-L1 expression as determined by a specified IHC
assay.
Exclusion Criteria:
1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
treatment, receipt of last dose of an approved anticancer therapy within 21 days
2. Concurrent or prior use of immunosuppressive medication within 14 days
3. Active or prior documented autoimmune or inflammatory disease within 3 years with some
exceptions.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of subjects reporting adverse events |
Time Frame: | Screening through 3 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective Response Rate |
Time Frame: | Screening through 5 years after the last subject receives the first dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Individual MEDI4736 concentrations |
Time Frame: | First dose of MEDI4736 through 3 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736 |
Time Frame: | First dose of MEDI4736 through 6 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Disease Control Rate |
Time Frame: | Screening through 5 years after the last subject receives the first dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Duration of Response |
Time Frame: | Screening through 5 years after the last subject receives the first dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival |
Time Frame: | Screening through 5 years after the last subject receives the first dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | Screening through 5 years after the last subject receives the first dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Individual tremelimumab concentrations |
Time Frame: | First dose of tremelimumab through 3 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Measure: | MEDI4736 area under the concentration-curve |
Time Frame: | First dose of MEDI4736 through 3 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Tremelimumab area under the concentration-curve |
Time Frame: | First dose of tremelimumb through 3 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Measure: | Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab |
Time Frame: | First dose of tremelimumab through 6 months after the last dose of study medication |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | MedImmune LLC |
Last Updated
October 23, 2017