D4193C00002: “A PHASE III RANDOMIZED, OPEN-LABEL, MULTI-CENTER, GLOBAL STUDY OF MEDI4736 MONOTHERAPY AND MEDI4736 IN COMBINATION WITH TREMELIMUMAB VERSUS STANDARD OF CARE THERAPY IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)”

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-043-15
• Date of registration: 07/12/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB,
• Public title: D4193C00002: “A PHASE III RANDOMIZED, OPEN-LABEL, MULTI-CENTER, GLOBAL STUDY OF MEDI4736 MONOTHERAPY AND MEDI4736 IN COMBINATION WITH TREMELIMUMAB VERSUS STANDARD OF CARE THERAPY IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)”
• Scientific title: D4193C00002: “A PHASE III RANDOMIZED, OPEN-LABEL, MULTI-CENTER, GLOBAL STUDY OF MEDI4736 MONOTHERAPY AND MEDI4736 IN COMBINATION WITH TREMELIMUMAB VERSUS STANDARD OF CARE THERAPY IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)”
• Date of first enrolment: 06/01/2016
• Target sample size: 22
• Recruitment status: Pending
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=043-15
• Study type: Interventional
• Study design: This is a randomized, open-label, multi-center, global Phase III study to determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination; therapy versus SoC therapy in the treatment of patients with recurrent or metastatic SCCHN who have progressed during or after treatment with a single regimen for recurrent or metastatic disease that contains platinum or who have progressed within 6 months from multimodality therapy containing platinum (ie, those who are refractory to prior platinum therapy). A schematic diagram of the overall study design is shown in Figure 1, a flow chart for the IMT treatment groups (MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy) is presented in Figure 2, and a flow chart for the SoC group is presented in Figure 3.
• Phase: III

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Haiti, Hungary, Israel, Italy, Japan, Korea South, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States

Contacts

• Name: Gino Silva Mejia
• Affiliation: PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC

• Name: Maria Mercedes Noya
• Affiliation: PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age ≥18 years at the time of screening
2. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. (For patients aged <20 years and enrolling in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.)
3. Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Patients who refuse radical resection are eligible.
4. 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 (for either locally
advanced disease or recurrent/metastatic disease).
THERE ARE OTHER CRITERIA
PLEASE REFERR TO PROTOCOL

Exclusion criteria:
1. Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck not specified in the inclusion criteria, patients with SCCHN of unknown primary, and non-squamous histologies (eg, nasopharynx or salivary gland)
2. Received more than 1 regimen for recurrent or metastatic disease
3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions for palliative intent is acceptable (eg, local surgery or radiotherapy).
4. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment. Receipt of last dose of an approved (marketed) anticancer therapy chemotherapy, targeted therapy, biologic therapy, mAbs, etc.) within 21 days prior to the first dose of study treatment. If sufficient washout time has not occurred due to the schedule or PK properties of an agent, a longer washout period will be required, as agreed upon by AstraZeneca and the Investigator.
THERE ARE OTHER CRITERIA
PLEASE REFERR TO PROTOCOL


Age minimum: 18
Age maximum: 99
Gender: Both

Health Condition(s) or Problem(s) studied

C14

-C50 Malignant neoplasm of breast -C14 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Malignant neoplasm of breast

Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

Malignant neoplasm of breast

C50

Intervention(s)

MEDI4736 monotherapy
 10 mg/kg via intravenous (IV) infusion every 2 weeks (q2w) for up to 12 months
(26 doses)
MEDI4736 + tremelimumab combination therapy
MEDI4736: 20 mg/kg via IV infusion every 4 weeks (q4w) for 4 doses then 10 mg/kg via IV
infusion q2w beginning 4 weeks after the last combination dose is administered for a total of
12 months of therapy (18 additional doses) AND
 Tremelimumab: 1 mg/kg via IV infusion q4w for 4 doses (4 doses total)

Source(s) of Monetary Support

Industria Farmaceutica

Ethics review

Status: Approved
Approval date: 11/06/2015
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 11/11/2015
Contact:

[e-mail]

Instituto Regional de Oftalmologia - Trujillo

044-249066

[e-mail]