Overview

This trial is active, not recruiting.

Condition squamous cell carcinoma of the head and neck
Treatments medi4736, tremelimumab
Phase phase 1
Targets CTLA-4, PD-1
Sponsor MedImmune LLC
Start date October 2014
End date March 2017
Trial size 69 participants
Trial identifier NCT02262741, D4190C00011

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 combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
medi4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
tremelimumab
Tremelimumab will be administered by IV infusion in combination with MEDI4736.

Primary Outcomes

Measure
Number of subjects reporting adverse events
time frame: Screening through 3 months after the last dose of study medication
Number of subjects reporting serious adverse events
time frame: Screening through 3 months after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
time frame: First dose of study medications through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
time frame: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiograms
time frame: Screening through 3 months through last dose of study medication
Change from Baseline in vital signs
time frame: Screening through 3 months after the last dose of study medication

Secondary Outcomes

Measure
Objective Response Rate
time frame: Screening through 5 years after the last subject receives the first dose of study medication
Individual MEDI4736 concentrations
time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
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
Disease Control Rate
time frame: Screening through 5 years after the last subject receives the first dose of study medication
Duration of Response
time frame: Screening through 5 years after the last subject receives the first dose of study medication
Progression Free Survival
time frame: Screening through 5 years after the last subject receives the first dose of study medication
Overall Survival
time frame: Screening through 5 years after the last subject receives the first dose of study medication
Individual tremelimumab concentrations
time frame: First dose of tremelimumab through 3 months after the last dose of study medication
MEDI4736 area under the concentration-curve
time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Tremelimumab area under the concentration-curve
time frame: First dose of tremelimumb through 3 months after the last dose of study medication
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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.