Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers

Part of paid clinical trials in Dallas, Texas.

Sponsor
Mary Crowley Medical Research Center
Study ID
NCT02725489
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vigil — BIOLOGICAL
    Vigil is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.
  • Durvalumab — DRUG
    A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)

Study Details

In this study, the researchers want to learn more about Vigil and durvalumab in advanced women's cancers: 1) how much of Vigil in combination with durvalumab (MEDI4736) can be given with an acceptable level of side effects, 2) the effects of Vigil and durvalumab in combination (good and bad), 3) if Vigil will cause changes in cancer cells that may help durvalumab attack the cancer, and 4) whether or not Vigil and durvalumab will slow your cancer or stop your cancer from getting worse. Combining Vigil with durvalumab will allow the former to induce (or increase) the infiltration of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed cell death ligand 1) expression. Consequently, the response rate of historically low or un-responsive cancer will be increased with the combination of Vigil and anti PD-L1.

Key Dates

Start date
Jun 3, 2016
Status verified
Jan 2021
Primary completion
Dec 30, 2019
Completion
Dec 2, 2020

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Cohort 1: 1x10^6 cells Vigil
    The first part will be a safety run-in comprised of 2 cohorts that will use a 3 + 3 design to determine the Vigil dose in Part 2. Cohort 1 will receive a low dose of Vigil (1x10\^6 cells/intradermal (ID) injection) in combination with durvalumab (1500 mg (if \> 30 kg) IV over 60 minutes) every 4 weeks.
  • Experimental: Part 1 Cohort 2: 1x10^7 cells Vigil
    Cohort 2 will receive Vigil at 1x10\^7 cells/ID injection and durvalumab (1500mg (if \> 30 kg) IV over 60 minutes) every 4 weeks.
  • Experimental: Part 1 Cohort -1: 1x10^5 cells Vigil
    If needed, Cohort -1 will be used which will receive Vigil at 1x10\^5 cells/ID injection and Durvalumab (1500mg (if \> 30 kg) IV over 60 minutes) every 4 weeks.

Primary Outcome Measure

Number of treatment-emergent AEs of Vigil + Durvalumab [ Time Frame: Up to 90 days after last dose of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mary Crowley Cancer Research CenterDallasTexas75230-

Find similar trials in Dallas, TX

By condition
Breast cancerCervical cancerEndometrial cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
Mary Crowley Cancer Research Center· Dallas, TX

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