Study of First Line MEDI4736 with or without Tremelimumab Versus standard of care chemotherapy in Recurrent or Metastatic Head and Neck cancer

Phase 1

Conditions: Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have not received prior systemic chemotherapy.
MedDRA version: 19.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003589-10-PT

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 628

Inclusion Criteria

1. Age =18 years at the time of screening
2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) ).
3. A fresh tumor biopsy for the purpose of screening or an available archival
tumor sample.
4. No prior systemic therapy for recurrent/metastatic disease. Systemic therapy given as part of multimodality treatment for locally advanced or locally recurrent disease is allowed.
5. World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 376
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 252

Exclusion Criteria

1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous
histologies (eg, nasopharynx or salivary gland)
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis