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Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

NCT03509012

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

Interventions: Durvalumab, Tremelimumab, Cisplatin (dose level 4), Cisplatin (dose level 3), Carboplatin (dose level 1)

Countries: United States, Japan, South Korea, Spain, Taiwan

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

Eligibility overview

Sex: ALL

Age: 18 Years to 110 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* World Health Organization (WHO)/ECOG performance status of 0 or 1
* Body weight \>30 kg at enrollment and treatment assignment
* At least 1 measurable lesion, not previously irradiated
* No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
* For patients with oropharyngeal HNSCC HPV status has to be known

Exclusion criteria:

* Patients with simultaneous primary malignancies or bilateral tumors
* Active or prior documented autoimmune or inflammatory disorders
* Brain metastases or spinal cord compression
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
* Has a paraneoplastic syndrome (PNS) of autoimmune nature
* HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
* NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
* SCLC cohort: Extensive-stage SCLC
Locations (16)
  • Tucson, Arizona, United States
  • Aurora, Colorado, United States
  • Houston, Texas, United States
  • Kōtoku, Japan
  • Sunto-gun, Japan
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Badalona, Spain
  • Madrid, Spain
  • Málaga, Spain
  • Taichung, Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan
  • Taoyuan City, Taiwan