CLINICAL TRIAL

KRAS peptide vaccine for Colorectal Cancer

Metastatic
Recruiting · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a vaccine may help prevent cancer from returning in individuals who have had cancer before.

See full description

About the trial for Colorectal Cancer

Eligible Conditions
Colorectal Carcinoma (CRC) · Colorectal Neoplasms · Pancreatic Neoplasms · Malignant Neoplasm of Pancreas

Treatment Groups

This trial involves 2 different treatments. 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ipilimumab
DRUG
KRAS peptide vaccine
DRUG
Nivolumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The cancer has spread to other parts of the body and has not responded to two more rounds of chemotherapy show original
The text states that for the metastatic MSS CRC cohort, the patient must have tumor lesions that are amenable to repeated biopsy, and the patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment is required if the lesion can be biopsied with an acceptable clinical risk. show original
We need tumor tissue for sequencing and phenotyping to continue our research. show original
The person has a tumor that expresses one of the six KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D or KRASG12R). show original
The text says that the life expectancy is greater than 6 months. show original
Prior to taking part in the study, participants must have laboratory tests to make sure their organs and marrow are functioning well. show original
Someone who is ECOG performance status 0 or 1 is considered to have a good prognosis. show original
For people with metastatic cancer that starts in the colon or rectum, the cancer must be able to be measured to determine if the treatment is working. show original
Age ≥18 years.
PDAC must not have any signs of disease, and the last dose of neoadjuvant and/or adjuvant chemotherapy/radiation therapy/or surgery must have been less than six months ago. show original
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 years.
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 KRAS peptide vaccine will improve 2 primary outcomes and 7 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of 2 years.

Number of participants experiencing study drug-related toxicities
2 YEARS
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
2 YEARS
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 16 weeks
2 YEARS
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells after vaccination at 16 weeks compare to pre-vaccination baseline.
2 YEARS
Percentage change of interferon (IFN)-γ-producing mutant-KRAS-specific CD8 and CD4 T cells
BASELINE, 4 YEARS
Percent change of IFN-γ-producing mutant-KRAS-specific CD8 and CD4 T cells at any time after vaccination.
BASELINE, 4 YEARS
Overall Survival (OS)
4 YEARS
OS will be measured as the number of months from the date of first vaccine dose until death or end of follow up. OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan Meier Curve
4 YEARS
Progression-free Survival (PFS) for iRECIST
4 YEARS
PFS per iRECIST is defined as the numbers of months from the date of the first vaccine dose to the date of disease progression or death due to any cause, which ever occurs first, for mCRC patients. Censored at the date of last scan for subjects without documentation of disease progression (iPD) at the time of analysis or relapse from complete response [iCR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per iRECIST (iPFS) criteria, iCR = disappearance of all target lesions, Partial Response (iPR) is =>30 percent decrease in sum of diameters of target lesions, Progressive Disease (iPD) is >20 percent increase in sum of diameters of target lesions, Stable Disease (iSD) is <30 percent decrease or <20 percent increase in sum of diameters of target lesions.
4 YEARS
Objective Response Rate (ORR) per RECIST 1.1
4 YEARS
ORR is defined as the number of patients with metastatic MSS CRC who are administered at least one dose of KRAS achieving a complete response (CR) partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30 percent decrease in sum of diameters of target lesions, progressive disease (PD) is >20 percent increase in sum of diameters of target lesions, stable disease (SD) is <30 percent decrease or <20 percent increase in sum of diameters of target lesions.
4 YEARS
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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 colorectal cancer?

A history of colorectal cancer should be sought in people with unexplained abdominal pain. Rectal bleeding and changes in bowel habit may indicate colon cancer.\n

Anonymous Patient Answer

Can colorectal cancer be cured?

The cure rate for primary and locally advanced tumours is around 90%, with good outcomes for most patients. However, in stage four (localised) disease, curative strategies remain limited and surgical treatment may be inadequate in some patients, with poor prognosis. A cure rate of 95% in advanced disease is achievable.

Anonymous Patient Answer

What causes colorectal cancer?

The exact cause is unknown, but many risk factors with moderate confidence can be identified, including H. pylori infection, NSAID, diet, and coffee consumption. Other risk factors are likely to be identified in the future.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

Treatment of early-stage [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is similar to treatment of colon cancer in general. Chemotherapy is frequently employed, followed by resection, which, if applicable, includes curative intent. Staging of rectal cancer is similar to colon cancer, and there may be a role of chemotherapy in a select group of patients.

Anonymous Patient Answer

What is colorectal cancer?

The most common type of colorectal cancer is adenocarcinoma, in which the normal cells are replaced by a glandular form of cells. Other types include mucinous tumours, which are related to the appendix; and squamous cell carcinoma, which is associated with colonisation by Chlamydia trachomatis or with the use of certain drugs. A colorectal cancer tumour can be identified by screening, by checking the stool for blood, or by obtaining a biopsy.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

Approximately 7500 people are diagnosed with colorectal cancer and 4000 per year die from the disease. There are 30000 new cases of colorectal cancer in the United States each year.

Anonymous Patient Answer

What are the common side effects of kras peptide vaccine?

Vaccination with kras peptide vaccine was safe and induced a transient antibody response in 90% of patients. Immunodiffusion and enzyme linked immunosorbent assays were validated reliable for kras peptide monitoring. There were no other deleterious and/or serious side effects in our study group, and no death occurred. The duration of antibodies production lasted a month after completion of vaccination.

Anonymous Patient Answer

What is kras peptide vaccine?

Immunization with the Kras peptide may constitute an effective and safe adjuvant that can also prevent pancreatic cancer. More research is needed, focusing on whether it can reduce progression of colon cancer.

Anonymous Patient Answer

Have there been any new discoveries for treating colorectal cancer?

There have been few significant advances for the treatment of colorectal cancer since it was last assessed in 2005. Ongoing efforts to further develop personalized treatments based on the individual patient's characteristics continue to be one of the key priorities for the treatment of colorectal cancer.

Anonymous Patient Answer

Who should consider clinical trials for colorectal cancer?

Patients with localized cancers and with curative potential should be considered for randomized trials. Patients with distant metastases should be considered only for trials examining clinical benefits for those who are asymptomatic.

Anonymous Patient Answer

How does kras peptide vaccine work?

Results from a recent paper suggest that, in addition to its antitumor effect, the Kras peptide vaccine also exerts potent chemopreventive effects on colorectal preneoplastic hyperplastic nodules.

Anonymous Patient Answer

Does colorectal cancer run in families?

There is a high percentage of colorectal cancer diagnosed in individuals with an affected first-degree relative. When an index case of colorectal cancer presents to an emergency room, it may be worthwhile to consider whether the patient exhibits a strong familial predisposition toward colorectal cancer in addition to some typical suspicion factors of colorectal cancer such as smoking, obesity, hyperhomocysteinemia etc. It may be prudent to consider a thorough pedigree review in the interest of preventing the passage of colorectal cancer.

Anonymous Patient Answer
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