VA Office of Research and Development
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.
Phase 2: Up to 30 participants with advanced/ metastatic or recurrent lung adenocarcinoma. Pembrolizumab will be given intravenously every 3 weeks for up to 12 cycles on Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, and 34. Subjects will be given LabVax 3(22)-23 (intradermally) and adjuvant GM-CSF (subcutaneously) on weeks 7, 8, 10, 13, and 19. Participants will receive study treatment over 34 weeks if tolerating the treatment without tumor progression; a safety follow-up visit will occur 30 days post-last dose of study treatment. The participant's chart will be reviewed for up to 12…
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…
LabVax 3(22)-23, and GM-CSF (adjuvant) in combination with pembrolizumab in subjects with advanced/metastatic or recurrent advanced/metastatic or recurrent lung adenocarcinoma.