Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
In brief
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
Key facts
- Study ID
- NCT03509012
- Run by
- AstraZeneca
- People needed
- 105
- Starts
- 2018-05-02
- Expected to finish
- 2025-01-08
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Tucson, Arizona, United States
- Research Site — Aurora, Colorado, United States
- Research Site — Houston, Texas, United States
- Research Site — Kōtoku, Japan
- Research Site — Sunto-gun, Japan
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Badalona, Spain
- Research Site — Madrid, Spain
- Research Site — Málaga, Spain
- Research Site — Taichung, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taoyuan City, Taiwan
Full record on ClinicalTrials.gov
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