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Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

StatusSuspended
PhasePhase 1
Started2026-03-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
Recruitment suspended: seeking additional funding
Primary completion pushed: 2026-12 → 2027-06
Completion pushed: 2026-12 → 2027-06
2026-08-07
Study Status, Eligibility v24
Eligibility criteria-124 characters
[...] last 6 months of treatment Subjects who are post-splenectomy, or otherwise asplenic, or have moderate to severe splenomegaly (defined as a spleen larger than 13 cm in cranial-caudal height or longest diameter) Personal history of anaphylactic reaction to previous vacci [...]
2026-07-17
Study Status, Contacts/Locations v23
Study sitescontacts updated at 1 of 1 site
2026-07-10
Suspended→Recruiting Study Status, Contacts/Locations v22
Trial statusSuspended→Recruiting
Reason stoppedGMP facility production hold→not stated
Study sitesdetails revised at 1 of 1 site
2026-05-21
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v21
Recruitment suspended
Reason stopped changed: — → GMP facility production hold
Primary completion pushed: 2026-09 → 2026-12
Completion pushed: 2026-09 → 2026-12
Eligibility criteria-23 characters
[...] within the specified ranges: Hemoglobin ≥ 8G/DL Platelets ≥ 150100 thou/cumm Absolute Neutrophil Count (ANC) ≥ 15001000 thou/cumm Serum total bilirubin ≤ 1.5 x upper limit of norm [...] in (based on modified Cockcroft and Gault formula) Must have measurable disease that is amenable to surgical sampling for RNA extra [...] cluded) Written informed consent obtained from the subject. Female subjectsParticipants of childbearing potential must have a negative serum pregnancy test at screening WomenParticipants of childbearing potential must be using an adequate method [...] minimize the risk of pregnancy. Prior to st [...]
Study sitesdetails revised at 1 of 1 site
Show 20 earlier versions
2026-04-27
Study Status, Contacts/Locations v20
Start dateestimated 2026-02→confirmed 2026-03-17
Study sitescontacts updated at 1 of 1 site
2026-01-16
Suspended→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Eligibility, Contacts/Locations v19
Trial statusSuspended→Recruiting
Reason stoppedPending GMP facility readiness & major protocol revision→not stated
Eligibility criteria+1,503 characters
Inclusion Criteria: Adults ≥ 18 years old ECOG performance ≤ 2 Lab values within the specified ranges: Hemoglobin ≥ 8G/DL Platelets ≥ 150 thou/cumm Absolute Neutrophil Count (ANC) ≥ 1500 thou/cumm Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN ⇅ moved Creatinine clearance (CrCl) ≥ 15 ml/min (based on modified Cockcroft and Gault formula) Must have disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles Subjects must not have more than one active malignancy at [...] [...]
Study description+2,365 characters
Melanoma is an increasing public health concern in the state of Florida. The advent of immune checkpoint inhibitors (ICI) has revolutionized the treatment of advanced melanoma. Unfortunately, in the adjuvant setting, up to 30% of subjects will have disease recurrence within 1 year of starting ICI th [...]
Study sitesdetails revised at 1 of 1 site
Collaborators+28 characters
Florida Department of Health
Study title-37 characters
Novel RNA-nanoparticlelipid Particle (RNA-LP) Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy Sensitization
2026-01-07
Study Status v18
Start date2025-12→2026-02
2025-09-04
Study Status v17
Reason stoppedPending finalization of PI change to Dr. Elliott & GMP facility readiness→Pending GMP facility readiness & major protocol revision
Start date2025-08→2025-12
2025-06-12
Study Status, Contacts/Locations v16
Reason stoppedcontamination issue in GMP facility→Pending finalization of PI change to Dr. Elliott & GMP facility readiness
Start date2025-04→2025-08
2025-04-01
Study Status v15
Reason stoppedInpatient vaccine administration logistics→contamination issue in GMP facility
Start date2025-02→2025-04
2024-12-11
Recruiting→Suspended Study Status, Contacts/Locations v14
Trial statusRecruiting→Suspended
Reason stoppednot stated→Inpatient vaccine administration logistics
Start date2024-11→2025-02
Study sitesdetails revised at 1 of 1 site
2024-10-25
Study Status, Eligibility v13
Eligibility criteria+2,141 characters
Inclusion Criteria: Adults ≥ 18 years old Must have measurable disease with evidence of progression (progressive disease, (or PD) by RECIST 1.1 criteria while receiving adjuvant aPD1 the [...] no other approved therapeutic options/or decline their use. Patients of any stage treated with immune checkpoint inhibition with primary or secondary immunotherapy resistance. Primary resistance is defined as a minimum drug exposure requirement of 8-12 weeks or roughly two doses of the immunotherapy with Lack of benefit defined as progressive disease at the [...] Must have received either PD1 oraPD1, combination aPD1 [...] [...]
2024-09-09
Study Status v12
Start date2024-08→2024-11
2024-07-24
Suspended→Recruiting Study Identification, Study Status, Contacts/Locations v11
Trial statusSuspended→Recruiting
Reason stoppedmajor protocol revision in progress→not stated
Start date2024-06→2024-08
Study sitesdetails revised at 1 of 1 site
2024-06-11
Study Status, Arms and Interventions, Outcome Measures, Eligibility v10
Eligibility criteria+643 characters
[...] ter completing adjuvant treatment for stage IIB-IV melanoma Patients with stage IV nonresectable disease with rare melanoma subtypes: (mucosal, acral, uveal, non-sun exposed) are eligible for the study if they fail to response to initial immunotherapy given in the first line metastatic setting. These rare subtypes do not respond to aPD1 blockade at the same [...] Must have received either PD1 or combination aPD1/CTLA-4 inh [...]
Secondary endpointsdetails revised at 1 of 2 entries
2024-04-16
Recruiting→Suspended Study Status, Contacts/Locations v9
Trial statusRecruiting→Suspended
Reason stoppednot stated→major protocol revision in progress
Start date2024-04→2024-06
Study sitesdetails revised at 1 of 1 site
2024-03-28
Study Status v8
Start date2024-02→2024-04
2024-01-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-11-16
Study Status, Contacts/Locations v6
Study sites0→1
2023-09-11
Study Status v5
Primary completion date2025-07→2026-09
Completion date2027-07→2026-09
Start date2023-07→2024-02
2023-06-29
Study Status v4
Start date2023-06→2023-07
2023-01-17
Study Identification, Study Status v3
Start date2023-01→2023-06
2022-11-17
Study Status v2
Start date2022-10→2023-01
2022-07-05
Study Status v1
Start date2022-05→2022-10
2022-02-22
Original filing
University of Florida
325 trials monitored
See 23 trials at risk
Melanoma
1,020 trials monitored
See 45 trials at risk
Sarcoma
947 trials monitored
See 53 trials at risk
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Trial Details
NCT Number NCT05264974
Lead Sponsor University of Florida
Collaborators: Florida Department of Health
Conditions Melanoma, Soft Tissue Sarcoma
Enrollment 18 participants
Start Date 2026-03-17
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-17