A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
This study tests a new cancer vaccine called Labvax 3(22)-23 combined with a drug called GM-CSF, with or without pembrolizumab, to treat advanced adenocarcinoma that has spread throughout the body. The vaccine is designed to help the immune system recognize and attack cancer cells. Researchers are evaluating whether this approach is safe and effective for patients with this type of cancer.
Key Objective:This trial is testing whether a targeted cancer vaccine combined with immune-boosting treatments can improve survival and shrink tumors in patients with advanced adenocarcinoma.
Who to Consider:Patients with advanced stage adenocarcinoma who have limited treatment options or whose cancer has not responded to standard therapies should consider enrolling.
Trial Parameters
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Brief Summary
This phase 1/2 trial tests the safety and effectiveness of a cancer vaccine called Labvax 3(22)-23 and GM-CSF alone or 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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand and willingness to sign an informed consent form. 2. Subjects of at least 18 years of age with histologically confirmed diagnosis of adenocarcinoma. 3. Subjects with advanced/metastatic or recurrent solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 are eligible for participation. 4. For Phase 2, Cohort A, participants must have: 1. Histologically confirmed diagnosis of labyrinthin-positive lung adenocarcinoma. 2. Received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy. 3. 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). 5. For Phase 2, all subjects must be candidates for pembrolizumab therapy. 6. Subjects can eith