HER2 Vaccine for Locally Advanced Breast Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Pravin T.P Kaumaya
Study ID
NCT06949410
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HER2 Vaccine — DRUG
    MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines

Study Details

The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.

Key Dates

First listed
Apr 29, 2025
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HER2 Vaccine Arm
    MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left-\>right-\>left), with a booster administered at 6 months.

Primary Outcome Measure

Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0 [ Time Frame: through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin & Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Niraj Shah
[email protected]
317-278-3420
Pravin Kaumaya, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials
By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Indiana University Melvin & Bren Simon Comprehensive Cancer Center· Indianapolis, IN

Related Studies