CompletedPhase 1NCT03509012

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

StatusCompleted
PhasePhase 1
U.S. locations16
SponsorAstraZeneca
01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

View original record ↗