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Clinical Trials/EUCTR2015-003589-10-GR
EUCTR2015-003589-10-GRActive, not recruitingPhase 1

A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients - KESTRE

AstraZeneca AB0 sites760 target enrollmentStarted: November 3, 2015Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
760
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 456
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 304

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

Investigators

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