Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer

Part of paid clinical trials in Newport Beach, California.

Sponsor
Genelux Corporation
Study ID
NCT02759588
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Olvi-Vec — BIOLOGICAL
    Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
  • Platinum-doublet with or without bevacizumab — DRUG
    Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab.

Study Details

The purpose of this study is to determine if Olvi-Vec oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.

Key Dates

First listed
May 3, 2016
Start date
May 31, 2016
Status verified
May 2026
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b - Cohort 1
    Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu.
  • Experimental: Phase 1b - Cohort 2
    Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu.
  • Experimental: Phase 1b - Cohort 3
    Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu.
  • Experimental: Phase 2
    Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab.

Primary Outcome Measure

Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b) [ Time Frame: Change from baseline during Treatment and for 30 days following last dose over average of 2 years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Gynecologic Oncology AssociatesNewport BeachCalifornia92663-
AdventHealth Cancer InstituteOrlandoFlorida32804-

Find similar trials in Newport Beach, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Gynecologic Oncology Associates· Newport Beach, CAAdventHealth Cancer Institute· Orlando, FL

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