Third Trial Seeks Head&Neck Cancer Patients - 06-22-2015 09:00 PM
Third Trial Seeks Head & Neck Cancer Patients
Descriptive Information
Brief Title:
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
Description:
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 as monotherapy and MEDI4736 + tremelimumab combination therapy versus Standard of Care (SoC) therapy in the target patient population.
Study Type:
Interventional
Condition:
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Intervention:
Drug: MEDI4736 Monotherapy
Drug: MEDI4736 + Tremelimumab combination therapy
Drug: Standard of Care
Countries:
United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine
Start Date: September 2015
Completion Date: June 2018
Recruitment Information
Recruitment Status: Recruiting
Estimated Enrollment: 720 patients
Gender: Both
Ages: 18 Years and older
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years
* Written informed consent obtained from the patient/legal representative
* Histologically confirmed recurrent or metastatic SCCHN
* Tumor progression or recurrence during or after treatment with 1 regimen for recurrent or metastatic disease that must have contained platinum or progression within 6 months from multimodality therapy containing platinum
* Confirmed PD-L1-positive or -negative SCCHN by a specified immunohistochemistry (IHC) assay
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least 1 lesion
* Not previously irradiated
* No prior exposure to immune-mediated therapy
* Adequate organ and marrow function
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
Exclusion Criteria:
* Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
* Received more than 1 regimen for recurrent or metastatic disease
* Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment
* Receipt of any investigational anticancer therapy within 28 days or 5 half-lives
* Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies (mAbs), etc.) within 21 days prior to the first dose of study treatment
* Major surgical procedure within 28 days prior to the first dose of Investigational Product
* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade greater than or equal to 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion
* Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness
* Patients with a history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
* Mean QT interval corrected for heart rate (QTc) greater than or equal to 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
* History of active primary immunodeficiency
* Known history of previous tuberculosis
* Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product
* Pregnant or breast-feeding female patients
* Known allergy or hypersensitivity to Investigational Product
For More Information
AstraZeneca Cancer Study Locator:
1-877-400-4656 or [email protected]
Clinical Trials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02369874
Additional Information
NCT Number: NCT02369874
Study ID Number: D4193C00002
Study Sponsor: AstraZeneca
Descriptive Information
Brief Title:
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
Description:
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 as monotherapy and MEDI4736 + tremelimumab combination therapy versus Standard of Care (SoC) therapy in the target patient population.
Study Type:
Interventional
Condition:
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Intervention:
Drug: MEDI4736 Monotherapy
Drug: MEDI4736 + Tremelimumab combination therapy
Drug: Standard of Care
Countries:
United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine
Start Date: September 2015
Completion Date: June 2018
Recruitment Information
Recruitment Status: Recruiting
Estimated Enrollment: 720 patients
Gender: Both
Ages: 18 Years and older
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years
* Written informed consent obtained from the patient/legal representative
* Histologically confirmed recurrent or metastatic SCCHN
* Tumor progression or recurrence during or after treatment with 1 regimen for recurrent or metastatic disease that must have contained platinum or progression within 6 months from multimodality therapy containing platinum
* Confirmed PD-L1-positive or -negative SCCHN by a specified immunohistochemistry (IHC) assay
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least 1 lesion
* Not previously irradiated
* No prior exposure to immune-mediated therapy
* Adequate organ and marrow function
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
Exclusion Criteria:
* Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
* Received more than 1 regimen for recurrent or metastatic disease
* Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment
* Receipt of any investigational anticancer therapy within 28 days or 5 half-lives
* Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies (mAbs), etc.) within 21 days prior to the first dose of study treatment
* Major surgical procedure within 28 days prior to the first dose of Investigational Product
* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade greater than or equal to 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion
* Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness
* Patients with a history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
* Mean QT interval corrected for heart rate (QTc) greater than or equal to 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
* History of active primary immunodeficiency
* Known history of previous tuberculosis
* Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product
* Pregnant or breast-feeding female patients
* Known allergy or hypersensitivity to Investigational Product
For More Information
AstraZeneca Cancer Study Locator:
1-877-400-4656 or [email protected]
Clinical Trials.gov: https:/
Additional Information
NCT Number: NCT02369874
Study ID Number: D4193C00002
Study Sponsor: AstraZeneca