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

Phase 1

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Biological: MEDI4736; Biological: tremelimumab

• Registration Number: NCT02262741
• Lead Sponsor: MedImmune LLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-13
• Study Start: 2014-10-15
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEDI4736 + tremelimumab	MEDI4736	-
MEDI4736 + tremelimumab	tremelimumab	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Toronto, Ontario, Canada