150 Participants Needed

Personalized Cancer Vaccine for Pancreatic and Colorectal Cancer

MO
Overseen ByMichael Overman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or have had chemotherapy or radiotherapy within 2 weeks before starting the trial treatment.

Is the personalized cancer vaccine safe for humans?

Research shows that personalized peptide vaccines for cancer, including pancreatic and colorectal cancer, are generally safe, with rare severe side effects like skin reactions and inflammation at the injection site. Most severe adverse events were due to cancer progression or other treatments, not the vaccine itself.12345

How is the Personalized Cancer Vaccine treatment different from other treatments for pancreatic and colorectal cancer?

The Personalized Cancer Vaccine treatment is unique because it uses synthetic peptides tailored to the specific mutations found in a patient's tumor, aiming to trigger a targeted immune response. This approach contrasts with standard treatments that are not personalized and do not specifically target individual tumor mutations.26789

What data supports the effectiveness of the treatment Synthetic Tumor-Associated Peptide Vaccine Therapy for pancreatic and colorectal cancer?

Research shows that personalized peptide vaccines can trigger an immune response in some patients with advanced pancreatic cancer, suggesting potential benefits. In a study, two out of five patients developed an immune response to a specific mutation in their tumor after receiving a synthetic peptide vaccine, indicating that this approach might help the body fight cancer.237910

Who Is on the Research Team?

Michael J Overman | MD Anderson Cancer ...

Michael J Overman, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic or colorectal cancer who have a life expectancy of more than 6 months and can provide tumor tissue. They must have had at least one line of standard chemotherapy, be able to use birth control, and not be pregnant or breastfeeding. Specific criteria apply for different cohorts within the study.

Inclusion Criteria

Patients must demonstrate an ability to understand and the willingness to sign a written informed consent document
I have metastatic colorectal cancer and have had or will have surgery to remove the cancer spread.
I have finished all my planned additional cancer treatments.
See 20 more

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.
I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.
I am not pregnant or breastfeeding.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive personalized synthetic tumor-associated peptide vaccine therapy with imiquimod, pembrolizumab, and/or sotigalimab, along with CT or MRI scans at specified intervals.

24 weeks
11 visits (in-person) for vaccine administration and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including assessments of overall survival and recurrence-free survival.

6 months
Regular follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Synthetic Tumor-Associated Peptide Vaccine Therapy
Trial Overview The trial is testing a personalized peptide vaccine made from patients' own tumor cells and blood, alongside other treatments like Pembrolizumab and Sotigalimab. It aims to see how well these work as biological therapies against advanced cancers that are hard to treat.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Cohort C and D (vaccine, imiquimod, pembrolizumab, APX005M)Experimental Treatment6 Interventions
Group II: Cohort B (personalized vaccine, imiquimod, pembrolizumab)Experimental Treatment5 Interventions
Group III: Cohort A (personalized vaccine, imiquimod)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pancreatic tumors are highly resistant to chemotherapy and are often diagnosed at advanced stages, leading to limited treatment options for patients.
Despite decades of research into vaccine therapies for pancreatic cancer, recent reviews indicate that none have successfully improved clinical outcomes, highlighting the ongoing challenges in developing effective treatments.
Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis?Mizuguchi, T., Torigoe, T., Satomi, F., et al.[2023]
A personalized four-peptide cancer vaccine targeting specific mutations in a pancreatic tumor led to a diverse and long-lasting immune response in a 62-year-old patient, contributing to a complete remission that has lasted for 4 years.
The study demonstrated that the vaccine elicited a significant T-cell response against three of the four peptides, with evidence of T-cell persistence over time, suggesting the potential for this approach to enhance tumor immunity and improve patient outcomes.
Immune monitoring and TCR sequencing of CD4 T cells in a long term responsive patient with metastasized pancreatic ductal carcinoma treated with individualized, neoepitope-derived multipeptide vaccines: a case report.Sonntag, K., Hashimoto, H., Eyrich, M., et al.[2019]
In a study of 309 pancreatic cancer patients undergoing personalized peptide vaccination (PPV), those who experienced 'immune boosting' (a significant increase in IgG levels post-vaccination) had longer survival rates, indicating that immune response plays a crucial role in treatment efficacy.
Pre-vaccination factors such as high C-reactive protein levels, advanced disease stage, and previous chemotherapy courses were linked to reduced clinical benefits from PPV, suggesting that inflammation and disease progression impact the effectiveness of this personalized treatment.
Investigation of factors associated with reduced clinical benefits of personalized peptide vaccination for pancreatic cancer.Uchino, Y., Muroya, D., Yoshitomi, M., et al.[2021]

Citations

Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis? [2023]
Immune monitoring and TCR sequencing of CD4 T cells in a long term responsive patient with metastasized pancreatic ductal carcinoma treated with individualized, neoepitope-derived multipeptide vaccines: a case report. [2019]
Investigation of factors associated with reduced clinical benefits of personalized peptide vaccination for pancreatic cancer. [2021]
Ex vivo ras peptide vaccination in patients with advanced pancreatic cancer: results of a phase I/II study. [2020]
Vaccination with mutant ras peptides and induction of T-cell responsiveness in pancreatic carcinoma patients carrying the corresponding RAS mutation. [2020]
Characteristics of severe adverse events after peptide vaccination for advanced cancer patients: Analysis of 500 cases. [2010]
Induction of p53-specific immunity by a p53 synthetic long peptide vaccine in patients treated for metastatic colorectal cancer. [2021]
Immunotherapy Shows Promise in Pancreatic Cancer. [2020]
Immunological evaluation of personalized peptide vaccination for patients with pancreatic cancer. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
Colorectal cancer vaccines: Tumor-associated antigens vs neoantigens. [2020]
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