Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
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
Checked against the public recordLast updated Jan 14, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: Durvalumab; Drug: Tremelimumab; Drug: Cisplatin (dose level 4); Drug: Cisplatin (dose level 3); Drug: Carboplatin (dose level 1); Drug: Carboplatin (dose level 2); Drug: Etoposide (dose level 1); Drug: Etoposide (dose level 2); Drug: Paclitaxel; Drug: Pemetrexed; Radiation: External beam radiation (dose level 1); Radiation: External beam radiation (dose level 2); Radiation: External beam radiation (hyperfractionated); Drug: Cisplatin (dose level 1); Drug: Cisplatin (dose level 2); Radiation: External beam radiation (standard)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteTucson, Arizona
- Research SiteAurora, Colorado
- Research SiteHouston, Texas
- Research SiteKōtoku
- Research SiteSunto-gun
- Research SiteSeoul
- Research SiteSeoul
- Research SiteSeoul
- Research SiteSeoul
- Research SiteBadalona
- Research SiteMadrid
- Research SiteMálaga
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 14, 2025. Always confirm current availability with the study team.