NCT02298959

Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer

A Phase 1 Trial of MK-3475 Plus Ziv-Aflibercept in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety, tolerability and recommended phase II dosing for the combination of ziv-aflibercept plus MK-3475 (pembrolizumab) in patients with unresectable stage III or stage IV melanoma, renal cell cancer, ovarian cancer, colorectal cancer, or sarcoma. SECONDARY OBJECTIVES: I. To obtain preliminary estimates of progression-free survival at 6 months. II. To obtain preliminary estimates of the rate of 1-year overall survival. III. To obtain preliminary estimates of the response rate. IV. To obtain preliminary estimates of time to progression. V. To perform correlative sciences that provide information regarding the mechanisms of action for this combination treatment. OUTLINE: This is a dose-escalation and dose expansion study of ziv-aflibercept. Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes and ziv-aflibercept IV over 1-2 hours on day 1. Cycles repeat every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), blood sample collection and tumor biopsy throughout the study. After completion of study treatment, patients are followed up for at least 12 weeks.

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Colorectal Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Ovarian Carcinoma
• Metastatic Renal Cell Carcinoma
• Platinum-Resistant Ovarian Carcinoma
• Recurrent Melanoma
• Recurrent Renal Cell Carcinoma
• Refractory Melanoma
• Refractory Renal Cell Carcinoma
• Sarcoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Elastography	Undergo MRI
BIOLOGICAL	Pembrolizumab	Given IV
BIOLOGICAL	Ziv-Aflibercept	Given IV

Timeline

• Start date: 2015-04-08
• Primary completion: 2025-05-21
• Completion: 2027-01-20
• First posted: 2014-11-24
• Last updated: 2026-04-13

Locations

9 sites across 2 countries: United States, Canada