For Healthcare Professionals

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

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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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion criteria:


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

EXCLUSION CRITERIA

Exclusion criteria:


  1. Patients with simultaneous primary malignancies or bilateral tumors
  2. Active or prior documented autoimmune or inflammatory disorders
  3. Brain metastases or spinal cord compression
  4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
  5. Has a paraneoplastic syndrome (PNS) of autoimmune nature
  6. 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
  7. NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
  8. SCLC cohort: Extensive-stage SCLC

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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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