Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Etoposide; Etoposide phosphate; Paclitaxel; Pemetrexed; Tremelimumab

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:

• 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