Trial · NCT02636582

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

NCT02636582, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer. Trials, record NCT02636582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02636582

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer
NCT number: NCT02636582
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Breast Ductal Carcinoma In Situ
Interventions: Laboratory Biomarker Analysis, Nelipepimut-S Plus GM-CSF Vaccine, Sargramostim, Surgical Procedure
First posted: 2015-12-22
Last updated: 2023-12-05
Results first posted: 2023-05-16

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)	One-Month post-surgical resection from baseline	Change from baseline in the Mean percent of Nelipepimut-S-specific cytotoxic T lymphocyte response one-month post-surgical resection. Wilcoxon rank sum test exact P-value was used.
Secondary	Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane	Baseline to surgical resection, up to 5 weeks	Change from baseline in the iTILs at surgical resection. Wilcoxon rank sum test exact P-value was used.
Secondary	Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)	Baseline to surgical resection, up to 5 weeks	Change from baseline in the iTILs at surgical resection. Wilcoxon rank sum test exact P-value was used.
Secondary	Number of Participants With HER2 Expression in Biopsy and Resection Specimens	Baseline to surgical resection, up to 5 weeks	Difference in HER2 Expression in Biopsy and Resection Specimens. Differences were assessed using a Fisher's exact test.
Secondary	Number of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03	3-6 months after surgery	The number of serious and non serious adverse events for both arms. Graded According to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03.
Secondary	Number of Participants With Presence of Ductal Carcinoma in Situ (DCIS)	At resection	Presence of DCIS with Invasive Cancer.
Other	Immune Cell Analysis	up to 6 months after completion of the vaccination series timepoint	Will utilize tissue-based cyclic immunofluorescence (t-CyCIF), a novel, highly multiplexed imaging modality that follows the imaging of formalin-fixed, paraffin embedded (FFPE) tissue sections at subcellular resolution across 20-60 distinct antigen channels. 4-6 panels that will be used include both my not be limited to an already optimized immune panel.
Other	Immune Infiltrates in Normal Tissue Maximally Distant From the Tumor (in Mastectomy Samples)	Up to 6 months after completion of the vaccination series timepoint	In the mastectomy samples only will perform core needle biopsies of the normal tissue, maximally distant from the tumor (ex vivo after the mastectomy if performed and store for future studies of immune infiltrates.
Other	Toxicity Profile According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03)	up to 3 months after surgery
Other	Degree of Lymphocyte Infiltration	Up to 6 months after completion of the vaccination series timepoint	We will define intra-tumoral TIL as those within the basement membrane. Stromal TIL will be defined as those in the periductal/lobular stroma including the intralobular stromal infiltrate. Cells in the interlobular stromal inflammatory infiltrate will be excluded. All mononuclear cells will be scored but polymorphonuclear leukocytes will be excluded. Intra-tumoral and stromal TILs will be scored as a continuous variable and the percentage of in the surgical specimen will be compared to that in the pre-vaccination diagnostic biopsy.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)	One-Month post-surgical resection from baseline	percent of cytotoxic T lymphocytes	MEAN
SECONDARY	Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane	Baseline to surgical resection, up to 5 weeks	percent of iTILs	MEDIAN
SECONDARY	Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)	Baseline to surgical resection, up to 5 weeks	percent of iTILs	MEDIAN
SECONDARY	Number of Participants With HER2 Expression in Biopsy and Resection Specimens	Baseline to surgical resection, up to 5 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03	3-6 months after surgery	adverse events	NUMBER
SECONDARY	Number of Participants With Presence of Ductal Carcinoma in Situ (DCIS)	At resection	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Immune Cell Analysis	up to 6 months after completion of the vaccination series timepoint
OTHER_PRE_SPECIFIED	Immune Infiltrates in Normal Tissue Maximally Distant From the Tumor (in Mastectomy Samples)	Up to 6 months after completion of the vaccination series timepoint
OTHER_PRE_SPECIFIED	Toxicity Profile According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03)	up to 3 months after surgery
OTHER_PRE_SPECIFIED	Degree of Lymphocyte Infiltration	Up to 6 months after completion of the vaccination series timepoint

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)	GM-CSF		0.09	Inter-Quartile Range 0 to 0.15	percent of cytotoxic T lymphocytes
Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)	NPS+GM-CSF		0.02	Inter-Quartile Range 0 to 0.14	percent of cytotoxic T lymphocytes
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane	GM-CSF		0	Inter-Quartile Range -0.5 to 3.0	percent of iTILs
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane	NPS+GM-CSF		0.5	Inter-Quartile Range -0.3 to 0.5	percent of iTILs
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)	GM-CSF		0	Inter-Quartile Range -5 to 0	percent of iTILs
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)	NPS+GM-CSF		0	Inter-Quartile Range -17.5 to 14.5	percent of iTILs
Number of Participants With HER2 Expression in Biopsy and Resection Specimens	GM-CSF	HER2 expression - biopsy 1+	2		Participants
Number of Participants With HER2 Expression in Biopsy and Resection Specimens	NPS+GM-CSF	HER2 expression - biopsy 1+	3		Participants
Number of Participants With HER2 Expression in Biopsy and Resection Specimens	GM-CSF	HER2 expression - biopsy 2+	2		Participants
Number of Participants With HER2 Expression in Biopsy and Resection Specimens	NPS+GM-CSF	HER2 expression - biopsy 2+	0		Participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GM-CSF (Control)	4
Overall Study	STARTED	Nelipepimut-S (NPS+GM-CSF)	9
Overall Study	At Surgery	GM-CSF (Control)	4
Overall Study	At Surgery	Nelipepimut-S (NPS+GM-CSF)	9
Overall Study	1- Month Post-Op	GM-CSF (Control)	4
Overall Study	1- Month Post-Op	Nelipepimut-S (NPS+GM-CSF)	9
Overall Study	3-6 Months Post-Op	GM-CSF (Control)	3
Overall Study	3-6 Months Post-Op	Nelipepimut-S (NPS+GM-CSF)	9
Overall Study	COMPLETED	GM-CSF (Control)	3
Overall Study	COMPLETED	Nelipepimut-S (NPS+GM-CSF)	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	GM-CSF	0	4
other	Abdominal pain	Gastrointestinal disorders	NPS+GM-CSF	1	9
other	Allergic Reaction	Immune system disorders	GM-CSF	0	4
other	Allergic Reaction	Immune system disorders	NPS+GM-CSF	1	9
other	Arthralgia	Musculoskeletal and connective tissue disorders	GM-CSF	0	4
other	Arthralgia	Musculoskeletal and connective tissue disorders	NPS+GM-CSF	2	9
other	Breast Infection	Infections and infestations	GM-CSF	0	4
other	Breast Infection	Infections and infestations	NPS+GM-CSF	1	9
other	Breast Pain	Reproductive system and breast disorders	GM-CSF	2	4
other	Breast Pain	Reproductive system and breast disorders	NPS+GM-CSF	3	9

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GM-CSF	0	4
Total, all-cause mortality	NPS+GM-CSF	0	9
Total, other adverse events	GM-CSF	4	4
Total, other adverse events	NPS+GM-CSF	9	9
Total, serious adverse events	GM-CSF	2	4
Total, serious adverse events	NPS+GM-CSF	0	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GM-CSF vs NPS+GM-CSF: deaths from any cause	Trial comparisons
GM-CSF vs NPS+GM-CSF: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02636582

GET https://conductscience.org/api/trials/v1/NCT02636582/results?page=2

API reference For AI assistants