NCT02318771

Radiation Therapy and MK-3475 for Patients With Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma, and Lung Cancer

An Exploratory Study to Investigate the Immunomodulatory Activity of Radiation Therapy (RT) in Combination With MK-3475 in Patients With Recurrent/Metastatic Head and Neck, Renal Cell Cancer, Melanoma and Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial studies radiation therapy and MK-3475 in treating patients with head and neck cancer, kidney cancer, melanoma, or lung cancer that has returned, has spread to other parts of the body, or cannot be removed by surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as MK-3475, may block tumor growth by targeting certain cells and causing the immune system to attack the tumor. Studying the effects of MK-3475 with radiation therapy on the body may help doctors learn whether it may be an effective treatment for these solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To investigate the immunomodulatory activity of radiation therapy (RT) or RT in combination with anti-programmed cell death 1 (PD)-1 antibody (MK-3475) in patients with recurrent/metastatic head and neck cancer, renal cell cancer, melanoma and lung cancer. SECONDARY OBJECTIVES: I. To explore whether programmed cell death ligand 1 (PD-L1) expression is associated with treatment response to the combination of RT and PD-1 blockade in renal cell cancer (RCC), head and neck cancer (HNC), lung cancer and melanoma. II. To explore whether circulating tumor cells can be used to determine PD-L1 expression. III. To explore other immune-related biomarker changes after RT: soluble PD-L1, cytokines etc. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM A1: Patients undergo radiation therapy on day 1 per standard of care and then undergo biopsy 3-10 days later. Beginning 0-7 days after biopsy, patients receive MK-3475 intravenously (IV) over 30 minutes on day 1. Courses of MK-3475 repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM A2: Patients undergo radiation therapy on days 1-5 and then undergo biopsy 3-10 days later. Beginning 0-7 days after biopsy, patients receive MK-3475 as in Arm A1. ARM B1: Patients receive one dose of MK-3475 IV over 30 minutes on day 1 and then undergo 1 fraction of RT. Patients then receive MK-3475 IV over 30 minutes in the absence of disease progression or unacceptable toxicity. ARM B2: Patients receive MK-3475 as in Arm B1 and undergo 5 fractions of RT. After completion of study treatment, patients are followed up at approximately 30 days and then every 8 weeks.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Metastatic Renal Cell Cancer
• Recurrent Head and Neck Carcinoma
• Recurrent Lung Carcinoma
• Recurrent Renal Cell Carcinoma
• Recurrent Skin Carcinoma
• Stage III Renal Cell Cancer
• Stage IV Lung Cancer
• Stage IV Skin Melanoma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy (RT)	Undergo RT
DRUG	MK-3475	Given IV

Timeline

• Start date: 2015-02-05
• Primary completion: 2018-06-05
• Completion: 2021-03-25
• First posted: 2014-12-17
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study