Labyrinthin Expression Is Associated with Poor Prognosis in Patients with Non-Small-Cell Lung Cancer.
Weijie Ma, Jie Zeng, Dennis J Montoya...
https://pubmed.ncbi.nlm.nih.gov/36765881Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05101356
A Phase 1/2 Study of LabVax 3(22)-23 and GM-CSF Alone or With Pembrolizumab for Labyrinthin-Positive Advanced Adenocarcinomas
Led by Tianhong Li · Updated on 2024-05-21
77
Participants Needed
1
Research Sites
208 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
Researchers are studying advanced stage adenocarcinoma that has spread in the body to evaluate the safety and immune response effects of a cancer vaccine called Labvax 3(22)-23 and a protein called GM-CSF, given alone or combined with pembrolizumab. Labvax 3(22)-23 targets a protein called labyrinthin found on tumor cells but not on normal cells, aiming to train the immune system to attack the cancer. This phase 1/2 trial may improve understanding of how the body responds to this vaccine and combination therapy for adenocarcinoma treatment. In phase 1, up to 10 participants with advanced adenocarcinoma receive Labvax 3(22)-23 injections under the skin and GM-CSF injections on weeks 1, 2, 4, 8, and 12, followed by 16 weeks of evaluation. Phase 2 includes up to 67 participants with lung or non-lung adenocarcinomas, receiving pembrolizumab intravenously every 3 weeks for up to 12 cycles, alongside Labvax 3(22)-23 and GM-CSF injections on weeks 7, 8, 10, 14, and 18. Treatment lasts up to 34 weeks if tolerated without disease progression, followed by safety follow-up and monitoring for 12 months. Participants will undergo exams, tumor assessments, and safety monitoring during and after treatment, including follow-up visits 30 days after the last dose. Researchers will measure side effects, immune responses, and tumor response rates for up to one year after treatment. The study includes detailed evaluations to track safety, treatment effects, and overall survival, with participants' medical records reviewed for up to a year post-treatment.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- At least 18 years old with confirmed adenocarcinoma
- Have advanced, metastatic, or recurrent solid tumors with measurable or non-measurable disease
- For Phase 2 Cohort A: labyrinthin-positive lung adenocarcinoma and prior anti-PD-1 or anti-PD-L1 therapy
- Must be candidates for pembrolizumab therapy
- May have progressed or not responded to prior cancer therapies
- Recovered from treatment-related toxicities to grade 1 or less (except certain neuropathies or endocrine conditions)
- No limit on prior therapy lines; completed chemotherapy, immunotherapy, or targeted therapy at least 3 weeks before study
- Completed palliative radiation at least 2 weeks before study
- Stable treated brain metastases allowed if off steroids for at least one week
- ECOG performance status of 0-1
- Life expectancy of 6 months or more
- Adequate organ function as defined by blood counts and liver/kidney tests
- Negative pregnancy test for women of childbearing potential
- Adequate archival tumor tissue available
You will not qualify if you...
- Autoimmune diseases requiring immunosuppressive medication beyond low-dose prednisone
- Prior splenectomy
- Pregnant or nursing women
- Medical or psychiatric conditions preventing participation or compliance
- Uncontrolled diseases that interfere with safety or compliance
- Severe infection within 4 weeks before enrollment
- Contraindications to GM-CSF (e.g., high leukemic blasts, allergies)
- Systemic steroid or immunosuppressive therapy within 7 days before treatment in Phase 2
- History of active tuberculosis
- Allergy to pembrolizumab or its components
- Recent monoclonal antibody therapy within 3 weeks or unresolved adverse events
- Recent chemotherapy, targeted therapy, or radiation within 2 weeks or unresolved adverse events
- Untreated symptomatic brain metastases or carcinomatous meningitis
- History of severe pneumonitis or interstitial lung disease
- Active infection requiring systemic therapy
- Conditions or abnormalities that could interfere with study results or participation
- Active Hepatitis B or C infection
- Received live vaccine within 30 days before starting study (except inactivated flu or COVID vaccines)
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 34 weeks depending on phase and treatment tolerance
Participants receive LabVax 3(22)-23 (intradermally) and sargramostim (subcutaneously) on weeks 1, 2, 4, 8, and 12. In Phase 2, participants also receive pembrolizumab 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, with additional LabVax 3(22)-23 and sargramostim given on weeks 7, 8, 10, 14, and 18.
Multiple visits including vaccinations on weeks 1, 2, 4, 7, 8, 10, 14, 18, and pembrolizumab infusions every 3 weeks up to 12 cycles
Follow-up
Duration - Up to 12 months
Participants have a safety follow-up visit 30 days after the last dose of study treatment. Their health is monitored through chart reviews for up to 12 months after the last dose.
1 follow-up visit (in-person) and chart reviews
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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