VX15/2503 with or without Ipilimumab and/or Nivolumab in Treating Patients with Resectable Stage IIIB-D Melanoma

Active:	No
Cancer Type:	Melanoma Unknown Primary	NCT ID:	NCT03769155
Trial Phases:	Phase I	Protocol IDs:	Winship4400-18 (primary) NCI-2018-01229 IRB00104273
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/NCT03769155

Summary

This phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab works in treating patients with stage IIIB-D melanoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as VX15/2503, 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. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on T cell infiltrate into the tumor microenvironment in involved and uninvolved lymph nodes and peripheral blood.

SECONDARY OBJECTIVES:
I. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on the immune profile of involved and uninvolved lymph nodes and peripheral blood.
II. Assess safety and tolerability of profile and tolerability of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors in patients with resectable metastatic melanoma.
III. Document pathologic response rates of VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.
IV. Compare pathologic response to radiographic response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients receiving single agent VX15/2503 and combination VX12/2503 and immune checkpoint inhibitors in patients with resectable melanoma.

OUTLINE: Patients are assigned to 1 of 5 arms.

ARM I: Patients receive pepinemab intravenously (IV) over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM II: Patients receive pepinemab IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM III: Patients receive pepinemab IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM IV: Patients receive nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM V: Patients undergo surgery.

After completion of study treatment, patients are followed up at 90 days, every 12 weeks for 2 years, every 6 months for 3 years, then annually up to 10 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.