NCT03509012

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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

Detailed description

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).

Conditions

• Carcinoma, Squamous Cell of Head and Neck
• Carcinoma, Non-Small-Cell Lung
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	IV (intravenous)
DRUG	Tremelimumab	IV
DRUG	Cisplatin (dose level 4)	IV
DRUG	Cisplatin (dose level 3)	IV
DRUG	Carboplatin (dose level 1)	IV
DRUG	Carboplatin (dose level 2)	IV
DRUG	Etoposide (dose level 1)	IV
DRUG	Etoposide (dose level 2)	IV
DRUG	Paclitaxel	IV
DRUG	Pemetrexed	IV
RADIATION	External beam radiation (dose level 1)	radiation therapy
RADIATION	External beam radiation (dose level 2)	radiation therapy
RADIATION	External beam radiation (hyperfractionated)	radiation therapy
DRUG	Cisplatin (dose level 1)	IV
DRUG	Cisplatin (dose level 2)	IV
RADIATION	External beam radiation (standard)	radiation therapy

Timeline

• Start date: 2018-05-02
• Primary completion: 2020-12-31
• Completion: 2025-01-08
• First posted: 2018-04-26
• Last updated: 2025-01-14

Locations

16 sites across 5 countries: United States, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study