Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 110
Updated:3/14/2019
Start Date:May 2, 2018
End Date:April 4, 2022
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER)

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

This study will initially treat up to approximately 300 patients with advanced solid tumors
at approximately 30 sites, worldwide. The study will be composed of a dose-limiting toxicity
(DLT) assessment phase (Part A) and an expansion phase (Part B).

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
We found this trial at
6
sites
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Aurora, CO
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