Status:
WITHDRAWN
Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Incyte Corporation
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer Metastatic
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following fi...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Have histologically or cytologically - proven cancer of the pancreas or colon.
- Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- Measurable disease as per RECIST 1.1.
- Have sufficient and accessible tissue for NGS and immune-phenotyping.
- Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy \>12 months prior to the diagnosis of metastatic disease may be eligible.
- ECOG performance status 0.
- Life expectancy of greater than 6 months.
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
- 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.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Is a candidate for definitive surgical resection.
- Is unwilling or unable to undergo standard of care therapy.
- Known history or evidence of brain metastases and/or leptomeningeal spread.
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.
- Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
- Known history or concurrent interstitial lung disease.
- Has a pulse oximetry \< 95% on room air.
- Requires the use of home oxygen.
- 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.
- Has been diagnosed with another cancer or myeloproliferative disorder within the past 5 year.
- Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
- Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.
- If at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.
- 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.
- Any radiological or clinical pleural effusions or ascites.
- Any peritoneal involvement by the tumor.
- History of malignant small bowel obstruction.
- On parenteral nutrition.
- Any liver metastasis greater than 3 cm or greater than 5 liver metastases.
- Known or suspected hypersensitivity to Hiltonol.
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04799431
Start Date
May 3 2023
End Date
May 3 2023
Last Update
May 9 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.