Pancreatic Cancer Clinical Trial
Official title:
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | May 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 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. - High Risk Group 1 (familial pancreatic cancer relatives): - >/=55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and - Come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and - Have a first-degree relationship with at least one of the relatives with pancreatic cancer. - If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened - High Risk Group 2 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher): - >/=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. - Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. o High Risk Group 3 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%): - >/= 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, 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. - Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. - Patients must have a pancreatic imaging abnormality that is being followed by pancreatic imaging surveillance (EUS and/or MRI and /or CT), such as a pancreatic cyst consistent with an IPMN or parenchymal abnormalities consistent with PanIN. - Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. - Ability to understand and willingness to sign a written informed consent document. - Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. - Men must use acceptable form of birth control while on study. Exclusion Criteria: - If expected to require any other form of systemic or localized antineoplastic therapy while on study. - Within 4 weeks prior to first dose of study drug. o Any systemic or topical corticosteroids at immunosuppressive agents. - Within 4 weeks prior to first dose of study drug. - Any investigational device. - Has received a live vaccine. - Received any allergen hyposensitization therapy. - Any major surgery. - Infection with HIV or hepatitis B or C. - Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements monoclonal antibody. - Has a diagnosis of immunodeficiency. - Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. - Unwilling or unable to follow the study schedule for any reason. - Are pregnant or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Stand Up To Cancer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants experiencing study drug-related toxicities | Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0 | 1.5 years | |
Primary | Maximal percentage of change of interferon (IFN-?) producing mutant-KRAS-specific CD8 and CD4 T cells | Maximal percent change per patient within 17 weeks after vaccination. | 17 weeks | |
Secondary | Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks. | Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks after vaccination compared to pre-vaccination baseline. | Baseline, 5 weeks | |
Secondary | Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks. | Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks after vaccination compared to pre-vaccination baseline. | Baseline 13 weeks | |
Secondary | Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks. | Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 (EOT) weeks after vaccination compared to pre-vaccination baseline. | Baseline,17 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT06054984 -
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Terminated |
NCT03140670 -
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
|
Phase 2 | |
Terminated |
NCT00529113 -
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT05168527 -
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05391126 -
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
|
N/A | |
Terminated |
NCT03300921 -
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT03153410 -
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
|
Early Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05679583 -
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04183478 -
The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer
|
Phase 2/Phase 3 | |
Terminated |
NCT03600623 -
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Completed |
NCT04290364 -
Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study
|