CLINICAL TRIAL

Nelipepimut-S Plus GM-CSF Vaccine for Carcinoma in Situ

Waitlist Available · 18+ · Female · New York, NY

This study is evaluating whether a vaccine made from peptides and/or a person's white blood cells mixed with tumor proteins can help the body build an effective immune response to kill tumor cells that express breast cancer.

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About the trial for Carcinoma in Situ

Eligible Conditions
Carcinoma, Ductal, Breast · Carcinoma, Ductal · Breast Ductal Carcinoma In Situ · Carcinoma, Intraductal, Noninfiltrating · Carcinoma in Situ

Treatment Groups

This trial involves 2 different treatments. Nelipepimut-S Plus GM-CSF Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nelipepimut-S Plus GM-CSF Vaccine
DRUG
Surgical Procedure
PROCEDURE
Laboratory Biomarker Analysis
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sargramostim
BIOLOGICAL
Surgical Procedure
PROCEDURE
Laboratory Biomarker Analysis
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2016
Completed Phase 2
~110

Eligibility

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 (Karnofsky >= 60%)
Participants must be pre- or post-menopausal
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-vaccination to up to 1 month after surgery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-vaccination to up to 1 month after surgery.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nelipepimut-S Plus GM-CSF Vaccine will improve 1 primary outcome and 7 secondary outcomes in patients with Carcinoma in Situ. Measurement will happen over the course of In the biopsy and the surgical specimen excised post-vaccination.

Difference in HER2 expression
IN THE BIOPSY AND THE SURGICAL SPECIMEN EXCISED POST-VACCINATION
HER2 scoring will be determined according to the American Society of Clinical Oncology/College of American Pathologists clinical guidelines. Positive cases are those with circumferential membrane staining that is complete, intense, and within > 10% of tumor cells (score 3+). Negative cases are defined as those with no observable staining, or membrane staining that is incomplete and is faint/barely perceptible and within less than or equal to 10% of tumor cells (score 0) or incomplete membrane staining that is faint/barely perceptible and within > 10% of tumor cells (score 1+). Equivocal or indeterminate cases are those with circumferential membrane staining that is incomplete and or weak/moderate and within > 10% of tumor cells or complete and circumferential membrane staining that is intense and within less than or equal to 10% of tumor cells (score 2+). Pre-vaccination and post-vaccination specimens will be compared.
Presence of ductal carcinoma in situ (DCIS)
AT RESECTION
The histologic data will be presented in tabular form to examine whether the vaccine treatment is associated with the absence of DCIS, induction of necrosis, reduction in histologic grade, or a reduction in the size of DCIS. These data will be descriptive only. The data will be obtained from the standard surgical pathology report generated as part of the patient's clinical care. Formal comparisons of these parameters would likely require a larger sample size to see a statistically significant difference in presence of DCIS, induction of necrosis, or reduction in size of DCIS.
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 allows for the imaging of formalin-fixed, paraffin embedded (FFPE) tissue sections at subcellular resolution across 20-60 distinct antigen channels. 4-6 Antibody panels that will be used include but may not be limited to an already optimized immune panel.
Degree of lymphocyte infiltration
UP TO 6 MONTHS AFTER COMPLETION OF THE VACCINATION SERIES TIMEPOINT
Will define intra-tumoral tumor infiltration lymphocyte (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.
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.
Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.03
UP TO 3 MONTHS AFTER SURGERY
Adverse events by grade and relationship will be summarized by tabulation for each group.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of carcinoma in situ?

A biopsy done for histology of the tissue under the microscope may confirm the presence of cancer in a specimen of breast tissue. The diagnosis of carcinoma in situ is made by examining small, light-microscopy stained sections—in this case, microscopic examination of the tumor cells under a microscope.

Anonymous Patient Answer

How many people get carcinoma in situ a year in the United States?

Carcinoma in situ presents a substantial annual health-care burden in the United States. There are likely many more CIS cases than the number found to be associated with invasive cancer, and the data obtained will help to improve detection and management of cervical CIS.

Anonymous Patient Answer

What are common treatments for carcinoma in situ?

Treatments of carcinoma in situ include surgery, radiotherapy, and endocervical curettage. When an abnormality is found on a Papanicolaou test or when cervical cytology is positive, patients should undergo treatment with conization or hysterectomy. If the abnormality is found on the Pap smear, radiation therapy can be a reasonable treatment but the patient should be counseled about the potential risk of cancer treatment.

Anonymous Patient Answer

Can carcinoma in situ be cured?

This information should be included in the counseling of patients with biopsy-confirmed CIS and in the discussions about risks and benefits of local excision (local cryotherapy), endoscopic treatment (local endometrial ablation), and systemic therapy for a cure.

Anonymous Patient Answer

What is carcinoma in situ?

Data from a recent study demonstrates that carcinoma in situ was almost exclusively located deep to the glandular duct layer. An in depth focus of a pathologist is required to confirm in situ diagnoses.

Anonymous Patient Answer

What causes carcinoma in situ?

The most critical issue seems to be avoiding carcinoma in situ progression to invasive disease, by avoiding a delay in diagnosis and by avoiding the use of any treatment that may exacerbate the disease progression. This can be achieved by close follow up of those diagnosed with carcinoma in situ and in those at risk for progression.

Anonymous Patient Answer

Does carcinoma in situ run in families?

The relative risk (RR) for cancer in situ among siblings of probands with carcinoma in situ was not significantly different from the RR expected for siblings with the same cancer risk based on age at diagnosis, sex and cancer type. The RR of cancer in situ was also relatively equal across siblings (1.3) compared with the RR expected based on age (1.9) and sex (1.9) but it was considerably higher than that expected from the RR (0.6) based on cancer type (0.6).

Anonymous Patient Answer

What is the survival rate for carcinoma in situ?

The current national (1996) average survival rate of patients diagnosed with CIS was 81.2%. The long-term survival of patients with CIS is relatively high. Most of the relapse occurs in the first year after diagnostic treatment is completed or in the first 3 years.

Anonymous Patient Answer

What does nelipepimut-s plus gm-csf vaccine usually treat?

The nelipepimut-s plus gm-csf adjuvanted vaccine can help to treat CIS grade 3, 4, and/or in stage T0N0M0 patients. The vaccine can also help to treat grade 1, 2, and/or in stage T1N0M0 patients.

Anonymous Patient Answer

How does nelipepimut-s plus gm-csf vaccine work?

Nelipepimut-s/S-GM-CSF and TC-S vaccine immunotherapy were safe and effective; and TC-S did not significantly add to activity in this group. The data provide a basis for a large-scale trial of PIS/S-GM-CSF and TC-S vaccinations with S1E7 alone or in combination as primary end points. This trial was conducted at the Clinical Center of the Russian Academy of Medical sciences. Trials.gov number, NCT00241242.

Anonymous Patient Answer

How serious can carcinoma in situ be?

The rate of transformation to invasive carcinoma is low if carcinoma in situ is surgically removed and is less than 1% in women younger than 46 or in women younger than 45 who are younger than 41 and has a small number of other risk factors for cancer (males with polyps/adenomas). Given these rates of carcinoma in situ, it is possible to make conservative decisions regarding the followup of people with carcinoma in situ of the breast.

Anonymous Patient Answer

What is nelipepimut-s plus gm-csf vaccine?

The use of neolypenimut-s plus gm-csf vaccine showed some benefit in clinical stage-2/3 ovarian cancer when combined with current regimens. The vaccine may help reduce the number of clinical stage-2/3 ovarian cancer patients who require chemotherapy in the future, but additional clinical trials are required to confirm the results.

Anonymous Patient Answer
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