Pepinemab with or without Ipilimumab and/or Nivolumab in Treating Patients with Stage I-IVA Head and Neck Squamous Cell Cancer

Active:	Yes
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT03690986
Trial Phases:	Phase I	Protocol IDs:	Winship4402-18 (primary) NCI-2018-01263 IRB00103534
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03690986

Summary

This phase I trial studies how well pepinemab with or without ipilimumab and/or nivolumab work in treating participants with stage I-IVA head and neck squamous cell cancer. Immunotherapy with monoclonal antibodies, such as pepinemab, ipilimumab, and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the effect of the pepinemab (VX15/2503) alone and VX15/2503 in combination with immune checkpoint inhibitors, ipilimumab or nivolumab, on the immune profile in the tumor microenvironment and in peripheral blood.

SECONDARY OBJECTIVE:
I. To extend the previously reported safety profile of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors, ipilimumab or nivolumab, in patients with head and neck squamous cell carcinoma.

OUTLINE: Patients are randomized to 1 of 6 groups.

GROUP I: Patients receive pepinemab intravenously (IV) over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

GROUP II: Patients receive pepinemab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

GROUP III: Patients receive pepinemab IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

GROUP IV: Patients receive nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

GROUP V: Patients ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

GROUP VI: Patients undergo standard of care surgery.

After completion of study treatment, patients are followed up at 4-8 weeks.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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