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Cancer Vaccine + Nivolumab + Ipilimumab for Pancreatic and Colorectal Cancer
Study Summary
This trial is testing a new cancer vaccine for patients with pancreatic or colorectal cancer who have not responded to other treatments. The vaccine will be given with two other drugs, nivolumab and ipilimumab.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't had any radiation treatment or gamma knife surgery in the last 2 weeks.I haven't taken high-dose steroids in the last 2 weeks.I have a liver metastasis larger than 5 cm or my liver is over 50% affected.I have had immunotherapy for pancreatic or colorectal cancer.I am a man and will use birth control during the study.I won't need any cancer treatment other than the study drug for 2 weeks before starting it.I am receiving my nutrition through an IV due to my metastatic colorectal cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 4 weeks.I haven't had chemotherapy in the last 4 weeks.My cancer has returned in one specific area, as shown on scans.I have not had major surgery in the last 4 weeks.I have been diagnosed with another cancer or blood disorder in the last 5 years.I have fluid buildup in my chest or abdomen.I have not received any growth factors in the last 4 weeks.I have or had brain metastases.I have been diagnosed with an immune system disorder.My colorectal cancer has spread to the lining of my abdomen.I have had a blockage in my intestines caused by cancer.I have finished all recommended treatments for a single cancer recurrence.I am 18 years old or older.I am a woman who can have children, have a negative pregnancy test, and will follow contraceptive guidelines.My organ and bone marrow functions meet the study's requirements.I have pancreatic or MSS colorectal cancer confirmed by tests.My colorectal cancer has spread and I've had at least 2 chemotherapy treatments.My colorectal cancer has spread, and I agree to multiple biopsies.My tumor has a specific KRAS mutation targeted by the vaccine.I have a history of or currently have interstitial lung disease.My colorectal cancer has spread and can be measured by scans.I have received an organ or tissue transplant.I am infected with HIV or hepatitis B or C.I do not have any unmanaged ongoing illnesses.My cancer has enough stored tissue for detailed genetic testing.
- Group 1: Treatment Phase
- Group 2: Reinduction Treatment Phase
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other examinations have been conducted regarding the efficacy of KRAS peptide vaccine?
"Presently, 764 trials related to KRAS peptide vaccine are underway. Of these undertakings, 86 are in the third phase of research and development. Though most experiments with this treatment occur in Pittsburgh, Pennsylvania there is a far-reaching network of 42760 sites conducting relevant studies."
Has the KRAS peptide vaccine been officially sanctioned by the FDA?
"Based on the available research, we can confidently assign KRAS peptide vaccine a score of 1. As this is still in its early phases, there's limited data to support both safety and efficacy."
What is the aim of this research project?
"According to the trial sponsor, Bristol-Myers Squibb, the primary outcome that will be evaluated over a span of two years is Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 16 weeks. Additionally, this study intends to assess various secondary objectives such as Objective Response Rate (ORR) per RECIST 1.1, Disease Free Survival (DFS), and iRECIST's ORR."
Are participants being actively recruited for this trial?
"Clinicaltrials.gov confirms that this study, which was originally posted on May 29th 2020 is currently open for recruitment and recently updated on August 12th 2022."
What diseases is the KRAS peptide vaccine routinely employed to address?
"KRAS peptide vaccine is typically used to address anti-angiogenic therapy, although it has seen success in treating other malignancies such as melanoma and squamous cell carcinoma."
What is the current enrollment count for this trial?
"Affirmative. In accordance with the information uploaded on clinicaltrials.gov, this medical study has resumed its search for participants after being initially posted on May 29th 2020 and was last modified on August 12th 2022. This experiment requires 30 volunteers to be recruited from a single facility."
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