KRAS peptide vaccine for Cancer of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
Cancer of Pancreas+2 More
KRAS peptide vaccine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely given to people with cancer.

See full description

Eligible Conditions

  • Cancer of Pancreas
  • High Risk Cancer
  • Malignant Neoplasm of Pancreas

Treatment Effectiveness

Study Objectives

This trial is evaluating whether KRAS peptide vaccine will improve 4 primary outcomes and 3 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 5, 13, and 17 weeks.

2 years
Number of participants experiencing study drug-related toxicities
Week 17
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5, 13 and 17 weeks.
Baseline and 2 years
Fold change in interferon-producing mutant-KRAS-specific CD4 T cells
Fold change in interferon-producing mutant-KRAS-specific CD8 T cells
Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells
Baseline and 4 years
Maximal percentage of change of IFN-γ-producing mutant-KRAS-specific CD4 T cells
Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 T cells

Trial Safety

Trial Design

1 Treatment Group

KRAS peptide vaccine
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. KRAS Peptide 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 1 and are in the first stage of evaluation with people.

KRAS peptide vaccine
Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 4 years for reporting.

Closest Location

Sidney Kimmel Comprehensive Cancer Center - Baltimore, MD

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
You have a family history of pancreatic cancer. show original
You have a first-degree relationship with at least one of the relatives with pancreatic cancer. show original
Must fall into one of the three categories defined as high risk of developing pancreatic cancer and are undergoing pancreatic surveillance AND 2) have documented radiographic evidence of a pancreatic abnormality such as a pancreatic cyst.
You are 55 years old or 10 years younger than the age of the youngest relative with pancreatic cancer. show original
If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened
>/=40 years old and the Patient is a carrier of FAMMM (p16/CDKN2A) mutation regardless of family pancreas cancer history.
OR >/= 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2 mutation.
You have a family member with pancreatic cancer. show original
The patient is a carrier of a known, BRCA1, or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is > 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.
A person with a known genetic mutation must have proof of mutation status show original

Patient Q&A Section

What are the signs of cancer of pancreas?

"The following are the important symptoms of cancer of the pancreas, for which patients need immediate evaluation and treatment:\n1. Abdominal pain\n2. Upper abdominal discomfort\n3. Abnormal bowel movements\n4. Weight loss\n5. Diarrhea\n6. Vomiting\n7. Constipation\n8. Lymphadenopathy (lymph node enlargement)\n\nPancreatic cancer is the fourth-most common cause of cancer death in Canada." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer of pancreas?

"Histology examination of pancreatic tumor biopsy sections has led to an understanding of the mechanisms of malignant growths in the pancreas. The most common causes of pancreatic carcinoma are chronic pancreatitis (chronic inflammation due to excessive secretion from acinar cells), pancreatic adenocarcinoma, and intraductal papillary mucinous neoplasms. Patients who have had endoscopic retrograde cholangiopancreatography (ERCP) should undergo repeat ERCP after 5 years to assess for remaining lesions. Patients with a positive result should undergo exploratory surgery for disease staging to determine whether adjuvant therapy is warranted." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer of pancreas?

"In 2018, there was little evidence supporting the use of [substance P] antagonists as an anti-inflammatory therapy for inflammatory bowel disease. This includes against ulcerative colitis and Crohn's disease; however, there were some benefits associated with the drug in treating irritable bowel syndrome (IBS) due to non-ulcerative IBS subtypes. Research suggests that smoking is associated with increased risk of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer). There is no evidence that [nonsteroidal anti-inflammatory drugs (NSAIDs)] increase the risk of pancreatic cancer. There is tentative evidence that [tinzaparin] may reduce risk of cancer of the pancreas." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cancer of pancreas?

"The risk of developing pancreatic cancer increases with age. Moreover, approximately 10% of all cases are diagnosed before the age of 40 years. Men and women younger than 40 years have about the same risk of developing pancreatic cancer. After the age of 60 years, however, women have a significantly increased risk compared to men. This difference can be attributed to higher rates of overweight and obesity among women." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer of pancreas?

"Sex-, race-, and ethnicity-adjusted average age at diagnosis of pancreatic cancer varies across racial groups within the United States. Race-specific average age at diagnosis differs according to sex and ethnicity. In a recent study, we found that men had a higher overall mean age at diagnosis than women and that African Americans had a younger median age at diagnosis than Caucasians." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in kras peptide vaccine for therapeutic use?

"Although this vaccine has only recently been developed, we believe that the results presented here warrant further study on the CEA-specific vaccination approach. Further studies will need to be conducted to assess the long-term safety profile and tolerability of the approach investigated in this report." - Anonymous Online Contributor

Unverified Answer

Is kras peptide vaccine typically used in combination with any other treatments?

"The Kras peptide vaccine was commonly combined with chemotherapy and/or radiotherapy in our study population. Results from a recent clinical trial suggest that the addition of immunotherapy to chemotherapy or radiotherapy may improve the survival rate of patients with pancreatic cancer. More prospective studies will be needed to confirm these results." - Anonymous Online Contributor

Unverified Answer

How does kras peptide vaccine work?

"Vaccine against ASPK peptide may provide protection against pancreatic cancer, also provides a good chance to stimulate antitumor immunity, and therefore has great potential value in treatment of pancreatic cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer of pancreas?

"There have not been any new developments in the cancer of pancreas even though many types of pancreatic cancers do exist. However, there was an increase in detecting pancreatic cancer due to more frequent screenings and early diagnosis. This helps decrease mortality rates of this type of cancer. The importance of this is because pancreatic cancer is one of the few cancers where there is a high chance of being cured if detected early." - Anonymous Online Contributor

Unverified Answer

What causes cancer of pancreas?

"It was concluded that there were some factors that increased the risk of developing Pancreas cancer. The main cause of pancreatic cancer is hereditary non-inherited pancreatic cancer (HNPCC), which is associated with genetic alterations in DNA repair pathways and endocrine cells. Other causes include age, sex, smoking, obesity, diabetes mellitus type 2 (DM2), alcohol consumption and familial adenomatous polyposis (FAP).\n\nIn India, pancreatic cancer is one of the most common types of cancers, accounting for 11% of all cancers in 2011. In 2012, it was found that pancreatic cancer had the highest mortality rate among all cancers in both men and women in India." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer of pancreas?

"Clinical trials provide an opportunity to understand the biology of pancreatic cancer and to evaluate the safety and efficacy of novel approaches. Patients with advanced pancreatic cancer should be considered for clinical trial enrollment." - Anonymous Online Contributor

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