A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma

Part of paid clinical trials in Sacramento, California.

Sponsor
Tianhong Li
Study ID
NCT05101356
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Adenocarcinoma
  • Advanced Malignant Solid Neoplasm
  • Metastatic Adenocarcinoma
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Adenocarcinoma
  • Recurrent Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antineoplastic Vaccine — BIOLOGICAL
    Given LabVax 3(22)-23 ID
  • Sargramostim — BIOLOGICAL
    Given SC
  • Pembrolizumab — BIOLOGICAL
    Given IV per standard of care

Study Details

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.

Key Dates

Start date
Oct 13, 2021
Status verified
May 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2030

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Treatment (sargramostim, LabVax 3(22)-23)
    Patients receive sargramostim SC and LabVax 3(22)-23 ID on weeks 1, 2, 4, 8, and 12 in the absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 2 Treatment (sargramostim, LabVax 3(22)-23, pembrolizumab)
    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. Participants will be given LabVax 3(22)-23 (intradermally) and adjuvant GM-CSF (subcutaneously) on weeks 7, 8, 10, 14, and 18.

Primary Outcome Measure

Phase 1: Dose-limiting toxicities (DLT) [ Time Frame: First LabVax 3(22)-23 injection through 14 days following the second LabVax 3(22)-23 injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Selina Laqui
[email protected]
916-734-0565
Tianhong Li (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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