Study Stopped
Revisions to eligibility/design being made prior to enrollment of first participants.
Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer
Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer
2 other identifiers
interventional
30
1 country
1
Brief Summary
Background: Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back. Objective: To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC. Eligibility: Adults aged 18 years or older with no sign of disease after surgery for NSCLC. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans. Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit: The study vaccine is given as 2-4 small shots under the skin of the thigh or arm. N-803 is given as a shot under the skin of the abdomen. Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study. Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment. Follow-up visits will continue for up to 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer
Started Jun 2026
Longer than P75 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedStudy Start
First participant enrolled
June 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2033
Study Completion
Last participant's last visit for all outcomes
December 30, 2035
June 12, 2026
June 5, 2026
7.5 years
December 6, 2022
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase II Component: To assess the frequency of immunologic responses to purified CT-X and autosomal CT antigens in NSCLC participants following vaccinations with H1299 cancer cell lysate and Montanide ISA-51 VG adjuvant in combination with N-803
Analyses which investigate immunologic responses to a panel of CT antigens in vaccinated participants. Serologic response will be defined as new antibody reactivity to a CT antigen, increased titer of an existing antibody, or IgM-to-IgG class switch following vaccination. Cell Mediated response will be evaluated using Elispot or comparable assays.CT X antigen reactivity assessed by peripheral blood assays one month following the first six vaccinations, and every 6 months during retreatment.
1 month following first 6 vaccinations, and every 6 months during retreatment
Phase I Component: To determine the safety of H1299 lung cancer cell lysate vaccines administered with Montanide (Registered Trademark) ISA-51 VG adjuvant and N-803
Assessment of safety and tolerability of the lysate vaccine regimen (DL1 and/or DL-1) with N-803 as determined by the frequency and severity of adverse events: AEs assessed by laboratory evaluations (before each cycle, every 2 weeks between vaccines 1 \& 2, at each treatment evaluation, and at the safety visit) and queries (before each cycle, at each treatment evaluation and at safety visit) from the start of study intervention through 30 days after the last dose of vaccine. Unsolicited AEs are assessed throughout the study including beyond safety visit.
before each cycle, every 2 weeks between vaccines 1 & 2 (AE only), at each treatment evaluation, and at the safety visit
Secondary Outcomes (1)
To determine disease-free survival (DFS) in lung cancer participants receiving adjuvant H1299 lung cancer cell lysate vaccines administered with Montanide (Registered Trademark) ISA-51 VG and N-803
every 12 weeks while on treatment, during follow up for every 3 months for 3 years then every 6 months for 2 years or disease progression, final DFS evaluation visit
Study Arms (2)
1/ Vaccine with Montanide Adjuvant
EXPERIMENTALH1299 cell lysate vaccine administered with Montanide (Registered Trademark) ISA-51 VG adjuvant without or with N-803 (Phase I component to determine H1299 cell lysate dose)
2/ Vaccine with Montanide Adjuvant and N-803
EXPERIMENTALH1299 cell lysate vaccine administered with Montanide (Registered Trademark) ISA-51 VG adjuvant with N-803 (H1299 cell lysate at dose determined in Phase I)
Interventions
H1299 cell lysate with Montanide (Registered) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered Trademark) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.
FDA-approved assays used off-label for study as treatment determining in-vitro diagnostic devices to assess subject PD-L1 quantitation. Testing will be performed on provided archival samples or on fresh sample that is collected at screening for confirmation of diagnosis; no additional sample collection for purposes of PD-L1 testing.
H1299 cell lysate with Montanide (Registered Trademark) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.
N-803 via subcutaneous injection in the abdomen at dose of 15 ug/kg every 4 weeks, on Day 1 of each cycle. N-803 dosing will be calculated using a weight obtained within 5 days prior to the first dose. Dose re-calculated at the beginning of each subsequent cycle in the event of a 10% or greater weight change.
Eligibility Criteria
You may qualify if:
- Participant with histologically or cytologically proven Stage IB-IIIA (T2a-T4/N0, T1- T3N1, T1-T2/N2) NSCLC per 8th edition TNM Staging System with no clinical evidence of active disease (NED) or minimal residual disease (MRD) not readily accessible by non-invasive biopsy or resection/radiation following standard therapy. Initial diagnosis must be confirmed by the NIH Laboratory of Pathology.
- History of PD-L1 expression in cancer cells \< 1% as determined by IHC analysis.
- Participant must be enrolled within 12 weeks following completion of prior SOC therapy.
- Participant must have an ECOG performance status of 0-2.
- Participant must be \>=18 years of age.
- Participant must be willing to co-enroll on protocol 06C0014 (Prospective Analysis of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies) allowing for the collection of blood for correlative experiments pertaining to this protocol and related translational research efforts in the Thoracic Surgery Branch.
- Participant must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters (all eligibility assessment/enrollment bloodwork must be done at NIH no more than 2 weeks prior to enrollment):
- Absolute neutrophil count greater than 1500/mm3
- Absolute lymphocyte count greater than 800/mm3
- Platelet count greater than 75,000/mm3
- Hemoglobin greater than 8 g/dL (participant may receive transfusions to meet this parameter)
- INR\< 1.5xULN
- Total bilirubin \< 1.5 x upper limits of normal (except those with Gilberts disease)
- Serum creatinine less than or equal to 1.6 mg/mL or the eGFR must be greater than 60 mL/min/1.73m2
- Seronegative for HIV antibody by bloodwork performed at NIH no more than 4 weeks prior to enrollment.
- +6 more criteria
You may not qualify if:
- Participants receiving other investigational agents.
- Participants on any active treatment for their cancer upon study entry.
- Participant who is initially rendered NED or have MRD following standard therapy but exhibit disease progression prior to initiation of vaccination.
- Participant requiring chronic systemic treatment with steroids above physiologic doses.
- Participant receiving warfarin anticoagulation, who cannot be transitioned to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours.
- Participant with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated CHF (\> NYHA Class II), or myocardial infarction within 6 months prior to initiation of study therapy.
- Participant with any of the following pulmonary function abnormalities: FEV, \< 35% predicted; DLCO \< 35% predicted (post-bronchodilator); oxygen saturation less than 92% on room air based on assessment at NIH or outside medical facility no more than 4 weeks prior to protocol enrollment.
- Active COVID infection
- Participant pregnancy
- Uncontrolled intercurrent illness occurring within 3 months prior to initiation of study therapy /social situations (as assessed by social services) that would limit compliance with study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David S Schrump, M.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2022
First Posted
December 8, 2022
Study Start (Estimated)
June 17, 2026
Primary Completion (Estimated)
December 30, 2033
Study Completion (Estimated)
December 30, 2035
Last Updated
June 12, 2026
Record last verified: 2026-06-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data from this study may be requested from other researchers after the completion of the primary endpoint.
- Access Criteria
- Data from this study may be requested by contacting the PI.
All IPD recorded will be shared upon request.