A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02262741
• Other study ID #: D4190C00011
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2014
• Last updated: October 20, 2017
• Start date: October 15, 2014
• Est. completion date: September 21, 2017

Study information

• Verified date: October 2017
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Biological:
• MEDI4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
• tremelimumab
Tremelimumab will be administered by IV infusion in combination with MEDI4736.

Locations

Country	Name	City	State
Canada	Research Site	London	Ontario
Canada	Research Site	Toronto	Ontario
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Chicago	Illinois
United States	Research Site	Detroit	Michigan
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fairway	Kansas
United States	Research Site	Greenville	South Carolina
United States	Research Site	La Jolla	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	New Haven	Connecticut
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Biomarkers	Evaluate biomarkers that may correlate with clinical activity of MEDI4736 monotherapy and in combination with tremelimumab	Screening through 3 months after the last patient receives the first dose of study medication
Other	Change from Baseline in Patient-Reported Outcomes		Screening through 5 years after the last patient receives the first dose of study medication
Primary	Number of subjects reporting adverse events		Screening through 3 months after the last dose of study medication
Primary	Number of subjects reporting serious adverse events		Screening through 3 months after the last dose of study medication
Primary	Number of subjects experiencing dose-limiting toxicities		First dose of study medications through 4 weeks after the first dose of study medication
Primary	Change from Baseline in laboratory evaluations		Screening through 3 months after the last dose of study medication
Primary	Change from Baseline in electrocardiograms		Screening through 3 months through last dose of study medication
Primary	Change from Baseline in vital signs		Screening through 3 months after the last dose of study medication
Secondary	Objective Response Rate		Screening through 5 years after the last subject receives the first dose of study medication
Secondary	Individual MEDI4736 concentrations		First dose of MEDI4736 through 3 months after the last dose of study medication
Secondary	Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736		First dose of MEDI4736 through 6 months after the last dose of study medication
Secondary	Disease Control Rate		Screening through 5 years after the last subject receives the first dose of study medication
Secondary	Duration of Response		Screening through 5 years after the last subject receives the first dose of study medication
Secondary	Progression Free Survival		Screening through 5 years after the last subject receives the first dose of study medication
Secondary	Overall Survival		Screening through 5 years after the last subject receives the first dose of study medication
Secondary	Individual tremelimumab concentrations		First dose of tremelimumab through 3 months after the last dose of study medication
Secondary	MEDI4736 area under the concentration-curve		First dose of MEDI4736 through 3 months after the last dose of study medication
Secondary	Tremelimumab area under the concentration-curve		First dose of tremelimumb through 3 months after the last dose of study medication
Secondary	Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab		First dose of tremelimumab through 6 months after the last dose of study medication