NCT02636582

Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

VADIS Trial: Phase II Trial of Nelipeimut-S Peptide Vaccine in Women With DCIS of the Breast

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate for nelipepimut-S-specific cytotoxic T lymphocyte (CTL; cluster of differentiation \[CD\]8+ T cell) response in patients receiving NeuVax (nelipepimut-S plus GM-CSF \[sargramostim\]) compared to patients receiving GM-CSF alone (control). SECONDARY OBJECTIVES: I. Toxicity profile and frequency of adverse events in women with ductal carcinoma in situ (DCIS) of the breast receiving nelipepimut-S vaccine as compared to women receiving GM-CSF alone. II. Presence of DCIS at resection. III. Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination. IV. Histologic responses: IVa. Degree of lymphocyte infiltration determined on hematoxylin and eosin (H\&E) stained slides and immune infiltration as determined by multiplex immunofluorescence staining for markers including but not limited to CD3, CD4 and CD8. IVb. Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nelipepimut-S plus GM-CSF vaccine intradermally (ID) on days 0 and 14 and then undergo surgery on day 28. ARM II: Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28. After completion of study treatment, patients are followed up at 1 and 3 months.

Conditions

• Breast Ductal Carcinoma In Situ

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nelipepimut-S Plus GM-CSF Vaccine	Given ID
BIOLOGICAL	Sargramostim	Given ID
PROCEDURE	Surgical Procedure	Undergo surgery

Timeline

• Start date: 2016-06-14
• Primary completion: 2019-07-22
• Completion: 2023-05-17
• First posted: 2015-12-22
• Last updated: 2023-12-05
• Results posted: 2023-05-16

Locations

4 sites across 1 country: United States