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

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ClinicalTrials.gov Identifier: NCT02262741
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: MEDI4736 Biological: tremelimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2014
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: MEDI4736 + tremelimumab Biological: MEDI4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.

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




Primary Outcome Measures :
  1. Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  2. Number of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  3. Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  4. Change from Baseline in laboratory evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  5. Change from Baseline in electrocardiograms [ Time Frame: Screening through 3 months through last dose of study medication ]
  6. Change from Baseline in vital signs [ Time Frame: Screening through 3 months after the last dose of study medication ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  2. Individual MEDI4736 concentrations [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  3. 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 ]
  4. Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  5. Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  6. Progression Free Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  7. Overall Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  8. Individual tremelimumab concentrations [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  9. MEDI4736 area under the concentration-curve [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  10. Tremelimumab area under the concentration-curve [ Time Frame: First dose of tremelimumb through 3 months after the last dose of study medication ]
  11. 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 ]

Other Outcome Measures:
  1. Changes in Biomarkers [ Time Frame: Screening through 3 months after the last patient receives the first dose of study medication ]
    Evaluate biomarkers that may correlate with clinical activity of MEDI4736 monotherapy and in combination with tremelimumab

  2. Change from Baseline in Patient-Reported Outcomes [ Time Frame: Screening through 5 years after the last patient receives the first dose of study medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262741


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Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC MedImmune LLC

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02262741     History of Changes
Other Study ID Numbers: D4190C00011
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs