Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Carcinoma, Squamous Cell of Head and Neck,Carcinoma, Non-Small-Cell Lung,Small Cell Lung Carcinoma
Age (in years)
18 - 110
Phase
Phase 1
Participants needed
105
Est. Completion Date
Dec 29, 2023
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03509012
Study number
D933BC00001
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