NCT03239145

Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

Phase Ib Study to Test the Safety and Potential Synergy of Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying an investigational combination of drugs as a possible treatment for advanced solid tumors: melanoma, ovarian, renal, or colorectal cancer. The drugs involved in this study are: * Pembrolizumab * AMG386

Detailed description

This research study is a Phase Ib clinical trial, which tests the safety of an investigational combination of drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drug is being studied. FDA (the U.S. Food and Drug Administration) has not approved of the combination of the study drugs pembrolizumab and AMG386 as a treatment for any disease. However, the FDA has approved pembrolizumab by itself for melanoma and non-small cell lung cancer. Pembrolizumab is a humanized monoclonal antibody, or specialized type of protein, produced in the laboratory for use in treating patients with the participant disease. Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells. AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen. Drugs that block blood vessel formation are called "anti-angiogenic" therapies. AMG386 has been used and is currently being used in other clinical trials treating different types of cancer. Information from these other clinical trials suggests that this drug may help stop tumor growth. In this research study, the investigators are interested in looking at the combination of AMG386 with pembrolizumab because research done in the laboratory has suggested that the immunotherapy effect could be limited by the presence of tumor vessels in a process called angiogenesis. Adding AMG386 to pembrolizumab may help overcome this limitation and augment the effect of pembrolizumab. This combination of study drugs is being researched to: * Determine the safety and tolerability of pembrolizumab and AMG386 at different dose levels. * Determine the side effects of pembrolizumab and AMG386 when they are given in combination * Determine if pembrolizumab in combination with AMG386 is a possible treatment for cancer * Determine if pembrolizumab in combination with AMG386 changes immune cells in the blood or tumor

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
DRUG	Trebananib	AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen

Timeline

• Start date: 2018-05-01
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2017-08-03
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study