NCT02639026

Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers

Phase I Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine how best to combine hypofractionated radiotherapy, MEDI4736, and tremelimumab and to determine how safe and tolerable hypofractionated radiotherapy, MEDI4736, and tremelimumab are when given together in subjects with metastatic, melanoma, non small cell lung cancer (NSCLC), breast cancer, and pancreatic cancer.

Conditions

• Metastatic
• Melanoma
• Non Small Cell Lung Cancer (NSCLC)
• Breast Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	two schedules of radiotherapy (8 Gy x 3 fractions and 17 Gy x 1 fraction)
DRUG	MEDI4736	20 mg/kg MEDI4736 every 4 weeks for 4 doses, followed by 10 mg/kg MEDI4736 monotherapy every 2 weeks for 18 doses
DRUG	Tremelimumab	1 mg/kg every 4 weeks for 4 doses

Timeline

• Start date: 2016-01-26
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2015-12-24
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States