Actively Recruiting
A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
Led by Tianhong Li · Updated on 2024-05-21
77
Participants Needed
1
Research Sites
428 weeks
Total Duration
On this page
Sponsors
T
Tianhong Li
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent
- Age 18 years or older
- Histologically confirmed adenocarcinoma diagnosis
- Advanced, metastatic, or recurrent solid tumors, measurable or non-measurable disease
- For Phase 2 Cohort A: labyrinthin-positive lung adenocarcinoma with prior anti-PD-1 or anti-PD-L1 therapy
- Progression on therapy if sensitizing mutation with FDA-approved targeted treatment exists
- Eligible for pembrolizumab therapy
- Recovered from significant toxicities to grade 1 or less, except some neuropathy or endocrine-related adverse events allowed
- No limit on prior metastatic therapies; prior treatments completed at least 3 weeks before study
- Treated brain metastases allowed if stable and off steroids for at least one week
- ECOG performance status 0-1
- Life expectancy of at least 6 months
- Adequate organ function (ANC ≥ 1,000 cells/μL; lymphocytes ≥ 75,000 cells/μL; creatinine clearance ≥ 30 mL/min; bilirubin and liver enzymes within specified limits)
- Negative pregnancy test for women of childbearing potential within 72 hours prior to first dose
- Adequate tumor specimens available
You will not qualify if you...
- Autoimmune disease requiring immunosuppressive therapy other than low-dose prednisone or physiologic replacement
- Prior splenectomy
- Pregnant or nursing women
- Medical or psychiatric conditions preventing participation or compliance
- Uncontrolled concomitant diseases
- Severe infection within 4 weeks prior to enrollment
- Contraindications to GM-CSF (e.g., excessive leukemic myeloid blasts, hypersensitivity)
- Systemic steroid or immunosuppressive therapy above allowed doses within 7 days prior to first dose in Phase 2
- Active tuberculosis history
- Hypersensitivity to pembrolizumab
- Recent monoclonal antibody or chemotherapy, targeted therapy, or radiation within specified time frames unless recovered
- Untreated symptomatic CNS metastases or carcinomatous meningitis; treated brain metastases must be stable and off steroids
- History of grade 3 or higher pneumonitis or interstitial lung disease related to prior therapies
- Active infection requiring systemic therapy
- Conditions or abnormalities affecting trial results or participation
- Active Hepatitis B or C infection
- Live vaccine received within 30 days before study start, except allowed inactivated flu and COVID vaccines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here