A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Gradalis, Inc.
Study ID
NCT03073525
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vigil — BIOLOGICAL
    The Vigil vaccine 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.
  • Atezolizumab — DRUG
    Atezolizumab was prepared and administered at the FDA approved dose and schedule as described in the U.S. Package Insert (USPI). The initial dose was administered over one hour and if well tolerated, subsequent infusions may have been administered over 30 minutes. Atezolizumab in formulation F03 (1200 mg per vial) was administered in 250 mL 0.9% NaCl IV infusion bags and infusion lines equipped with 0.2 μm in-line filters.

Study Details

The clinical trial was a companion study to protocol CL-PTL-119 (A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) NCT02346747). Participants who had investigational product (Vigil) successfully made but were not eligible to enroll onto the VITAL study or previously randomized to placebo were given the opportunity to participate in this protocol. The main goal of this clinical trial was to determine the safety of combining Vigil therapy with atezolizumab.

Key Dates

Start date
May 31, 2017
Status verified
Apr 2023
Primary completion
May 22, 2019
Completion
May 18, 2022

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Vigil + Atezo
    This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days.
  • Experimental: Part 2: Vigil first then combination Vigil + Atezo
    After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab) Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil 1 cycle = 21 days
  • Experimental: Part 2: Atezo first then combination of Vigil + Atezo
    After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab). Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. 1 cycle = 21 days
  • Other: Part 3: Atezo Only
    Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days

Primary Outcome Measure

Number of Treatment-emergent AEs of Vigil + Atezolizumab [ Time Frame: AEs reported from first treatment dose and up to 30 days after last treatment, about 12 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of South Alabama Mitchell Cancer InstituteMobileAlabama36604-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
Henry Ford HospitalDetroitMichigan48202-
Billings ClinicBillingsMontana59101-
Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer CenterLebanonNew Hampshire03756-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605-

Find similar trials in Mobile, AL

By condition
Cervical cancerOvarian cancerEndometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of South Alabama Mitchell Cancer Institute· Mobile, ALGeorgia Cancer Center at Augusta University· Augusta, GAHenry Ford Hospital· Detroit, MIBillings Clinic· Billings, MTDartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center· Lebanon, NHPrisma Health Cancer Institute· Greenville, SC

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