[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605982":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":57,"centralContacts":34,"locations":62,"responsibleParty":130,"collaborators":34,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":34,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":34,"enrollmentInfo":141,"targetDuration":34,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":34,"overallStatus":150,"whyStopped":34,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prevention (SurVaxM, montanide, sargramostim)","EXPERIMENTAL","Patients receive SurVaxM with montanide SC followed by sargramostim SC on day 0, week 2, week 4, and week 6. Patients then receive a booster dose of SurVaxM with montanide SC followed by sargramostim SC on week 18. Patients also undergo collection of blood samples throughout the trial.",[13,14,15,16,17],"Procedure: Biospecimen Collection","Drug: Montanide ISA 51 VG","Other: Questionnaire Administration","Biological: Sargramostim","Biological: SVN53-67\u002FM57-KLH Peptide Vaccine",[19,29,35,40,52],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9],[25,26,27,28],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Montanide ISA 51 VG","Given SC",[9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"OTHER","Questionnaire Administration","Ancillary studies",[9],{"type":41,"name":42,"description":32,"armGroupLabels":43,"otherNames":44},"BIOLOGICAL","Sargramostim",[9],[45,46,47,48,49,50,51],"23-L-Leucinecolony-Stimulating Factor 2","DRG-0012","Leukine","Prokine","rhu GM-CFS","Sagramostim","Sargramostatin",{"type":41,"name":53,"description":32,"armGroupLabels":54,"otherNames":55},"SVN53-67\u002FM57-KLH Peptide Vaccine",[9],[56],"SurVaxM",[58],{"name":59,"affiliation":60,"role":61},"Saikrishna S Yendamuri","Northwestern University","PRINCIPAL_INVESTIGATOR",[63,83,98,114],{"facility":64,"status":34,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Rocky Mountain Regional VA Medical Center","Aurora","Colorado","80045","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-104.83192,39.72943,{"lat":74,"lon":73},[77,82],{"name":78,"role":79,"phone":80,"phoneExt":34,"email":81},"Robert L. Keith","CONTACT","720-857-5120","Robert.keith@cuanschutz.edu",{"name":78,"role":61,"phone":34,"phoneExt":34,"email":34},{"facility":60,"status":34,"city":84,"state":85,"zip":86,"country":68,"countryCode":69,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Chicago","Illinois","60611",{"type":71,"coordinates":88},[89,90],-87.65005,41.85003,{"lat":90,"lon":89},[93,97],{"name":94,"role":79,"phone":95,"phoneExt":34,"email":96},"Seema A. Khan","312-503-4236","s-khan2@northwestern.edu",{"name":94,"role":61,"phone":34,"phoneExt":34,"email":34},{"facility":99,"status":34,"city":100,"state":101,"zip":102,"country":68,"countryCode":69,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":71,"coordinates":104},[105,106],-78.87837,42.88645,{"lat":106,"lon":105},[109,113],{"name":110,"role":79,"phone":111,"phoneExt":34,"email":112},"Saikrishna S. Yendamuri","716-845-1228","sai.yendamuri@roswellpark.org",{"name":110,"role":61,"phone":34,"phoneExt":34,"email":34},{"facility":115,"status":34,"city":116,"state":117,"zip":118,"country":68,"countryCode":69,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"University of Tennessee - Knoxville","Knoxville","Tennessee","37920",{"type":71,"coordinates":120},[121,122],-83.92074,35.96064,{"lat":122,"lon":121},[125,129],{"name":126,"role":79,"phone":127,"phoneExt":34,"email":128},"Sean Jordan","865-305-6955","SAJordan@utmck.edu",{"name":126,"role":61,"phone":34,"phoneExt":34,"email":34},{"type":131,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100605982","phase-2-testing-the-survaxm-vaccine-for-lung-cancer-prevention-100605982",false,"NCT07169617","Testing the SurVaxM Vaccine for Lung Cancer Prevention","Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer","Inclusion Criteria:\n\n* Former and current smokers (male and female) with a \\>= 20 pack year smoking history\n* Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score \\> 1.34%\n* Participants \\>= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants \\\u003C 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 60%)\n* Platelets \\>= 100,000\u002Fmicroliter\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (=\\\u003C 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 1.5 x institutional upper limit of normal\n* Serum creatinine =\\\u003C 1.5 x institutional upper limit of normal\n* The effects of SurVaxM plus montanide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and\u002For organ allograft\n* Participants may not be receiving any other chemotherapy (except hormonal agents), immunotherapy or investigational agent, or any immunosuppressive agent, including systemic steroids, including those given after organ transplant\n* Participants with current or prior malignancy except for the following:\n\n  * Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before screening and felt to be at low risk for recurrence by treating physician\n  * Adequately treated carcinoma-in-situ or basal cell carcinoma of the skin without current evidence of disease\n  * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer\n  * Prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (e.g., localized prostate cancer) may be included\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to montanide or granulocyte-macrophage colony-stimulating factor (GM-CSF)\n* Uncontrolled intercurrent illness, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because of the unknown effects of SurVaxM plus montanide on the fetus. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with SurVaxM plus montanide, breastfeeding should be discontinued if the mother is treated with SurVaxM plus montanide\n* Individuals participating in another interception trial with an immunomodulatory agent will be excluded from participation in this trial for a washout period of 6 months","ALL","18 Years",{"count":142,"type":143},80,"ESTIMATED","INTERVENTIONAL",[146],"PHASE2","This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.",[149],"Lung Carcinoma","NOT_YET_RECRUITING","2026-06-02",{"date":153,"type":154},"2026-06-03","ACTUAL",{"date":156,"type":143},"2026-07-01",{"date":158,"type":143},"2029-09-30",{"name":5,"class":6},4]