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: 18.1Level: 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-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-29
• Study Completion: 2020-07-06
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 823

Inclusion Criteria

1. Age > o = 18 years at the time of screening
2. Documented evidence of 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 chemotherapy for recurrent or metastatic disease
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. Received any systemic therapy for recurrent or metastatic SCCHN
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified