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.
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
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.
Sequential
LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab
Combination productLabVax 3(22)-23, and GM-CSF (adjuvant) in combination with pembrolizumab in subjects with advanced/metastatic or recurrent advanced/metastatic or recurrent lung adenocarcinoma.
Objective Response Rate (ORR) as Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1)
To assess antitumor activity per RECIST 1.1 of LabVax 3(22)-23 administered at the Recommended Phase 2 Dose (RP2D) and adjuvant GM-CSF in combination with pembrolizumab in participants with advanced/metastatic or recurrent lung adenocarcinoma who have received at least one line of immune checkpoint inhibitor therapy.
Dose-limiting toxicity (DLTs)
Number of participants with dose-limiting toxicities (DLTs) during the safety lead-in period
Adverse events
Number of participants with treatment-emergent adverse events assessed according to CTCAE v6.0
Median PFS
Median progression-free survival (PFS) in months
6-month PFS
Progression-free survival rate at 6 months in percentage of participants
Labyrinthin immunohistochemistry (IHC) expression
To measure the expression of Labyrinthin by IHC and the effects of LabVax 3(22)-23 in combination with pembrolizumab
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VA Office of Research and Development
Lead sponsor
San Francisco VA Health Care System
Collaborator
VA Long Beach Healthcare System
Collaborator
Kansas City Veteran Affairs Medical Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
