OncoMatch/Clinical Trials/NCT05101356
A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
Is NCT05101356 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Antineoplastic Vaccine and Sargramostim for advanced adenocarcinoma.
Treatment: Antineoplastic Vaccine · Sargramostim · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Allowed: EGFR sensitizing mutation
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)
Allowed: ALK sensitizing mutation
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)
Allowed: ROS1 sensitizing mutation
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)
Allowed: BRAF sensitizing mutation
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)
Allowed: RET sensitizing mutation
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)
Allowed: NTRK sensitizing mutation
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)
Allowed: MET sensitizing mutation
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)
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
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.
Cannot have received: anti-cancer monoclonal antibody
Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1
Cannot have received: chemotherapy
Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1
Cannot have received: targeted therapy
Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1
Cannot have received: radiation therapy
Has had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1
Lab requirements
Blood counts
absolute neutrophil count (anc) ≥1,000 cells / μl; absolute lym75,000 cells/μl
Kidney function
creatinine clearance as calculated per cockcroft-gault or mdrd formula ≥30 ml/min
Liver function
total bilirubin ≤ 1.5 x uln or direct bilirubin ≤ uln for participants with total bilirubin levels > 1.5 uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln or ≤ 5 x uln for subjects with liver
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
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