NCT03212469

A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

A Phase I/II Study Evaluating the Safety and Clinical Activity of Anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) Antibodies Administrated in Combination With Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic Squamous Cell Carcinoma of Head and Neck, Lung, Oesophageus, Cervix, Vagina,Vulva or Anus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Lung Cancer
• Oesophageal Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses Safety run of the triple combination: Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses, Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses
DRUG	Tremelimumab	Preliminary steps : Safety Runs Safety run of the triple combination: Tremelimumab at 75mg/Q4W for up to 4 doses Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses
RADIATION	SBRT	Preliminary steps : Safety Runs Safety run of the dual combination: SBRT at C1D15. Safety run of the triple combination: SBRT at C1D15. Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses

Timeline

• Start date: 2017-06-20
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2017-07-11
• Last updated: 2025-05-08

Locations

1 site across 1 country: France