Not yet recruitingPhase 2

Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma

Labyrinthin Vaccination for Patients With Lung Adenocarcinomas

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The participant's chart will be reviewed for up to 12 months post-last dose of study treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and cancer-fighting effects of the vaccine LabVax 3(22)-23 with GM-CSF, a protein that helps boost the immune system. Pembrolizumab, another cancer drug, is added in the second part. The study is for veterans with lung adenocarcinoma, a type of lung cancer, that has spread or come back.

This phase 2 trial tests the safety and effectiveness of a cancer vaccine called LabVax 3(22)-23 and GM-CSF in combination with pembrolizumab in treating adenocarcinoma that has spread to other places in the body (advanced stage). LabVax 3(22)-23 is designed to target a specific antigen (labyrinthin), which is a protein found on the surface of adenocarcinoma tumor cells. Labyrinthin is a protein that is not expressed on normal cells in the skin, lungs, salivary glands, pancreas, nor other tissues. In adenocarcinoma, the tumor cells produce too much labyrinthin causing them to express this protein on the surface of the tumor cells. One way to control the growth of these tumor cells is to teach the immune system to generate an immune response against the labyrinthin protein by vaccination against labyrinthin. GM-CSF, or sargramostim, is a protein that acts as a white blood cell growth factor. It has also been shown to stimulate immune system. Thus, administration of GM-CSF may help to boost the immune system response when given together with the vaccine. This study may improve the general knowledge about LabVax 3(22)-23 and how the body may generate an immune response to kill adenocarcinoma tumor cells. In the second phase of the study, participants will also receive pembrolizumab, which may improve anti-cancer activity when given with LabVax 3(22)-23 and GM-CSF.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must understand the study and agree to sign a consent form.
  • A tissue test must show lung adenocarcinoma with the labyrinthin protein. Enough stored tumor tissue must be available for testing.
  • You must have received at least one anti-PD-1 or anti-PD-L1 treatment, drugs that help the immune system fight cancer, and be able to receive pembrolizumab.
  • If your cancer has a gene change with an FDA-approved targeted drug, it must have worsened after at least one treatment.
  • Past cancer treatment may have stopped working, not worked, or caused side effects you could not tolerate. Most serious side effects must have improved to mild; some nerve and hormone problems may be moderate.
  • Cancer drug treatment must have ended at least 3 weeks before study treatment. Radiation to ease symptoms must have ended at least 2 weeks before.
  • You must be fully active or able to do light work, with an expected life span of at least 6 months. Blood counts and kidney and liver tests must meet study limits.
  • If you could become pregnant, you must have a negative pregnancy test within 72 hours before the first dose.

Who can't join

  • You are pregnant or breastfeeding, or you have had your spleen removed.
  • You have an illness where the immune system attacks your body and need drugs that weaken it. Prednisone of 10 mg daily or less and hormone replacement are allowed.
  • You have an uncontrolled illness, another health or mental health problem, or a severe infection within the past 4 weeks that the study doctor says makes joining unsafe or difficult.
  • You cannot safely receive GM-CSF, including because of certain blood cancer cell levels or an allergy to GM-CSF, yeast-based products, or its ingredients.
  • You have untreated, active cancer in the brain or its lining. Treated brain cancer may be allowed if stable and steroid rules are met; the second part has extra rules.
  • For the second part: you recently used drugs that weaken the immune system, including more than 10 mg of prednisone daily; are allergic to pembrolizumab; or have not met recovery and waiting-time rules after cancer treatment or major surgery.
  • For the second part: you have a history of active tuberculosis, active hepatitis B or C, an infection needing medicine that treats the whole body, or past severe lung swelling or damage linked to cancer treatment.
  • For the second part: you received a live vaccine within 30 days before treatment. Injected non-live flu vaccines and COVID vaccines are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Ability to understand and willingness to sign an informed consent form * Histologically confirmed diagnosis of lung adenocarcinoma * Subjects with advanced/metastatic or recurrent solid tumors, with measurable or non-measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 are eligible for participation. * Histologically confirmed diagnosis of labyrinthin-positive lung adenocarcinoma * Received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of non-Small Cell Lung Cancer (NSCLC). Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy * Progressed on at least one line of therapy if participant has a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations) * All subjects must be candidates for pembrolizumab therapy * Subjects can either have progressed, had no response, or intolerance to prior cancer therapy. Patients must have recovered from all clinically significant treatment-related toxicities to grade 1 or less, except chemotherapy-associated peripheral neuropathy (motor or sensory), or endocrine-related AE, in which recovery to ≤ Grade 2 is allowed. For endocrine-related AEs, physiological doses of replacement therapy (e.g., levothyroxine, insulin, hydrocortisone, or other replacement therapy for adrenal or pituitary insufficiency, etc.) are allowed. * No limit on prior lines of therapy for metastatic disease. Prior chemotherapy, immunotherapy (including pembrolizumab) or molecularly targeted therapy must have been completed at least 3 weeks prior to initiating study treatment. Prior palliative radiation must have been completed at least 2 weeks prior to initiating study treatment. * Subjects with known untreated, active brain and/or leptomeningeal metastases are excluded. Subjects with treated brain metastasis who are neurologically stable and off steroids for at least one week are eligible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy of ≥ 6 months at the time of initiating study treatment * Subjects must demonstrate adequate organ function as defined below: * Absolute neutrophil count (ANC) greater than or equal to 1,000 cells /Liter (L) * Absolute lymphocyte counts (ALCs) greater than or equal to 600 cells per microliter * Platelets greater than or equal to 75,000 cells/L * Creatinine clearance as calculated per Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula ≥30 milliliters(mL)/minute (min) * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), OR direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 times the ULN * Aspartate aminotransferase or serum glutamic-oxaloacetic transaminase (AST or SGOT) and alanine aminotransferase or serum glutamic-pyruvic transaminase (ALT or SGPT) ≤2.5 times the ULN, OR ≤5 times the ULN for participants with liver metastases * Because the effects of the study treatment on the unborn fetus or nursing infant are unknown, pregnant and nursing women are ineligible. Women of childbearing age must have a negative urine or serum pregnancy test-Human Chorionic Gonadotropin(HCG) within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Confirmation of adequate archival tumor specimens (i.e., sufficient specimens for ten, 5-7 micrometer (µm) thick, unstained sections) Exclusion Criteria: * Subjects who have autoimmune diseases that require immunosuppressive medications other than prednisone ≤ 10 milligram (mg) daily or equivalent. Physiological doses of replacement therapy (e.g., levothyroxine, insulin, hydrocortisone, or other replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of immunosuppressant and are allowed. * Prior splenectomy * Pregnant or nursing women * Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures. * Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the subject's safety or compliance on trial * Severe infection that in the opinion of the investigator would interfere with subject safety or compliance on trial within 4 weeks prior to enrollment * Subjects who have contraindications to GM-CSF injections according to the package insert (e.g., subjects with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (≥ 10%); known hypersensitivity to GM-CSF, yeast-derived products or any component of the product) Additional exclusion criteria for participants entering Phase 2: * Is receiving systemic steroid therapy (\> 10 mg prednisone oral daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients * Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier * Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subjects received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has known untreated, symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases requiring treatment, and are not using steroids (\> 10 mg prednisone oral daily or equivalent) for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has known history of ≥ grade 3 pneumonitis or interstitial lung disease related to radiation, immunotherapy, chemotherapy, or targeted therapy * Has an active infection requiring systemic therapy * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen (HBsAg) reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) * Has received a live vaccine within 30 days of planned start of study therapy Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. Corona Virus Disease (COVID) vaccines are allowed.

Study sites (4)

CA

MO