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Cancer Vaccine

Nelipepimut-S + GM-CSF Vaccine for Breast Cancer

Phase 2
Waitlist Available
Led By Powel H Brown
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after surgery
Awards & highlights

Study Summary

This trial is studying two possible treatments for breast cancer. One is a vaccine made from peptide or antigen mixed with tumor proteins. The other is a white blood cell booster called sargramostim. Researchers want to see if either of these treatments is more effective than no treatment at all.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-month post-surgical resection from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-month post-surgical resection from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)
Secondary outcome measures
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane
Number of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
+2 more
Other outcome measures
Degree of Lymphocyte Infiltration
Immune Cell Analysis
Immune Infiltrates in Normal Tissue Maximally Distant From the Tumor (in Mastectomy Samples)
+1 more

Side effects data

From 2023 Phase 2 trial • 43 Patients • NCT02636582
100%
Injection Site reaction
75%
Dermatitis radiation
75%
Pruritus
50%
Breast Pain
50%
Pain
50%
Skin Hyperpigmentation
25%
Headache
25%
Decreased Ejection Fraction
25%
Bruising
25%
Constipation
25%
Myalgia
25%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
NPS+GM-CSF

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nelipepimut-S plus GM-CSF vaccine)Experimental Treatment3 Interventions
Patients receive nelipepimut-S plus GM-CSF vaccine ID on days 0 and 14 and then undergo surgery on day 28.
Group II: Arm II (sargramostim)Active Control3 Interventions
Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelipepimut-S
Not yet FDA approved
Surgical Procedure
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,321 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Powel H BrownPrincipal InvestigatorM.D. Anderson Cancer Center
Elizabeth A MittendorfPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Breast Cancer Clinical Trial 2023: Nelipepimut-S Plus GM-CSF Vaccine Highlights & Side Effects. Trial Name: NCT02636582 — Phase 2
Nelipepimut-S Plus GM-CSF Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02636582 — Phase 2
~5 spots leftby Jun 2025
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