Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome
- Conditions
- Lynch Syndrome
- Registration Number
- NCT05419011
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Participants with LS defined as one of the following:<br><br> - Mutation positive: MLH1, MSH2/EPCAM and MSH6 genotypes with prior history of =1<br> colorectal neoplasms** (tubular or tubulovillous adenoma(s) or sessile serrated<br> polyps/adenomas/lesion(s) or traditional serrated adenoma(s)), and/or<br> colorectal cancer(s) (but no active cancer for 6 months)<br><br> - PMS2 genotype with prior history of colon cancer(s) (but no active cancer for 6<br> months)<br><br> - Note: Should be confirmed by pathology report or letter from endoscopist<br> to participant<br><br> - Participants must have at least part of the descending/sigmoid colon and/or rectum<br> intact<br><br> - Participants must be at least 6 months from any cancer-directed treatment (such as<br> surgical resection, chemotherapy, immunotherapy or radiation)<br><br> - Participants >= 18 years will be enrolled. Because the risk of LS related cancers is<br> very low in participants < 18 years of age, children and adolescents are excluded<br> from this study<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)<br><br> - Leukocytes >= 3,000/microliter<br><br> - Absolute neutrophil count >= 1,500/microliter<br><br> - Platelets >= 100,000/microliter<br><br> - Total bilirubin = institutional upper limit of normal Note: Higher bilirubin levels<br> (= 3 mg/dL) can be allowed if due to a known benign liver condition, i.e. Gilbert's<br><br> - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase<br> [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase<br> [SGPT]) =< 1.5 x institutional upper limit of normal<br><br> - Creatinine =< institutional upper limit of normal or estimated glomerular filtration<br> rate (eGFR) >= 60 ml/min/1.73m^2<br><br> - The effects of the Tri-Ad5 vaccines and N-803 on the developing human fetus at the<br> recommended therapeutic dose are unknown. For this reason, women of child-bearing<br> potential and men must agree to use adequate contraception (hormonal or barrier<br> method of birth control; abstinence) prior to study entry and for the duration of<br> study participation. Should a woman become pregnant or suspect she is pregnant while<br> participating in this study, she should inform her study physician immediately<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document<br><br> - Participants must be willing and able to space coronavirus disease (COVID) vaccines<br> at least 2 weeks prior to and 2 weeks after receipt of study agent<br><br>Exclusion Criteria:<br><br> - History of organ allograft or other history of immunodeficiency<br><br> - Known human immunodeficiency virus (HIV) with CD4 count < 540, hepatitis B virus<br> (HBV), or hepatitis C virus (HCV) infection. Subjects with laboratory evidence of<br> cleared HBV and HCV infection will be permitted. Poorly controlled HIV may prevent<br> an adequate immune response to the vaccine and will be an exclusion criterion<br><br> - Subjects requiring systemic treatment with corticosteroids (> 10 mg daily prednisone<br> equivalents) or other immunosuppressive medications within 3 months of vaccination<br><br> - Participants may not be receiving any other investigational agents<br><br> - History of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to adenovirus-based vaccines and N-803<br><br> - Uncontrolled intercurrent illness or psychiatric illness/social situations that<br> would limit compliance with study requirements<br><br> - Pregnant women are excluded from this study because of the unknown effects of the<br> vaccine and N-803 on the fetus. Because there is an unknown but potential risk for<br> adverse events (AEs) in nursing infants secondary to treatment of the mother with<br> the vaccine plus N-803, breastfeeding should be discontinued if the mother is<br> treated with the vaccine plus N-803<br><br> - History of untreated thrombotic disorders<br><br> - Participants who experienced severe side effects or allergic reactions to previous<br> adenovirus-based vaccines (such as Johnson and Johnson COVID vaccine) will be<br> excluded<br><br> - History of atrial fibrillation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence rate of the composite endpoint of adenomas (tubular, tubulovillous and serrated), advanced adenomas and colon cancer
- Secondary Outcome Measures
Name Time Method Association of clinical factors with immune responses;Incidence of extracolonic neoplasms