Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers
NCT02639026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2025-11-25
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
- 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
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Mark H. O'Hara, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-26
- Primary Completion
- 2023-06-27
- Completion
- 2023-06-27
Countries
- United States
Study Locations
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