Trial Purpose

These randomized phase I trials are intended to study pepinemab (VX15/2503) in combination with or without ipilimumab or nivolumab. The purpose is to determine how different treatments affect immune biomarkers in the tumor micro-environment and peripheral blood in patients with various solid tumor cancers.

Vaccinex’s approach is to reprogram immune suppression in the tumor microenvironment by potentially reducing the function and number of suppressive cells, such as myeloid derived suppressor cells, and thereby may overcome immune resistance mechanisms and increase activity of cytotoxic T cells.

Immunotherapy in Stage I-IVA resectable head and neck squamous cell cancer

Trial Details

About the Trial

All patients who enroll in the trial will receive standard of care surgery. Patients will be randomized to 1 of 6 groups to receive standard of care surgery, or immunotherapy with pepinemab, ipilimumab, nivolumab, pepinemab plus ipilimumab, or pepinemab plus nivolumab, prior to surgery.

Phase

Phase 1

Dates

Start Date
November 1, 2018

Estimated Study Completion Date
July 14, 2022

Sponsor

Emory University

Collaborators

Vaccinex Inc.

Products

pepinemab
Nivolumab
Ipilimumab

Trial Design

 

Click to enlarge

Age(s)

18 and Older

Condition(s)

Stage I-IVA resectable head and neck squamous cell cancer

Gender(s)

All

Immunotherapy in Resectable Stage IIIB-D Melanoma

Trial Details

About the Trial

All patients who enroll in the trial will receive standard of care surgery. Patients will be randomized to 1 of 5 arms to receive standard of care surgery, or two additional immunotherapy treatments on days 1 and 21 plus surgery between days 35-49. Immunotherapy treatment arms include pepinemab + nivolumab, pepinemab + ipilimumab, pepinemab + nivolumab plus ipilimumab, or nivolumab alone. Biomarker analysis and pathologic response will be evaluated.

Phase

Phase 1

Dates

Start Date
December 13, 2018

Estimated Study Completion Date
December 31, 2021

Sponsor

Emory University

Collaborators

Vaccinex Inc.

Products

pepinemab
Nivolumab
Ipilimumab

Trial Design

 

Click to enlarge

Age(s)

18 and Older

Condition(s)

Stage IIIB-D melanoma that can be removed by surgery

Gender(s)

All