CompletedPhase 1/2

GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer

United States46 participantsStarted 2016-05

Plain-language summary

The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.

Who can participate

Age range21 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed, written informed consent. * High-grade serous (including Malignant Mixed Mullerian Tumor (MMMT) with metastasis that contains high grade epithelial carcinoma), endometrioid, or clear-cell ovarian cancer which includes: (1) platinum-resistant (recurrence or progression in \< 6 months) or (2) platinum-refractory (progression while on platinum-based therapy); patient must have failed either at least 2 consecutive therapies or are not eligible for additional cytotoxic therapies (exception is Phase 2 receiving chemotherapy with/without bevacizumab). * Intermediate platinum-sensitive patients (recurrence of disease 6 to 12 months from last platinum compound treatment): Recurrent ovarian carcinoma with at least four prior individual treatment regimens including at least two separate platinum-based therapies with recurrence from the last platinum-based regimen less than 12 months, who are unwilling or unable to undergo additional platinum-based cytotoxic therapy (this sub-population is not applicable for Phase 2 receiving chemotherapy with/without bevacizumab). * Performance status ECOG is at 0 or 1, and life expectancy of 6 months * Has either measurable disease in the peritoneal cavity as defined by RECIST 1.1 (Phase 1b \& 2) or has non-measurable disease in the peritoneal cavity (Phase 1b) and can be confirmed by laparoscopy and/or elevated CA-125. Patients who have non-measurable disease that is not identifiable by PET/PET-CT scan, but who have elev…

What they're measuring

Incidence of Treatment-emergent Adverse Events [Safety and Tolerability] (Phase 1b)

Timeframe: Change from baseline during Treatment and for 30 days following last dose.

Determine Progression-free Survival following Treatment (Phase 2)

Timeframe: From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.

Tumor Marker Cancer Antigen-125 (CA-125) (Phase 2)

Timeframe: Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.

Overall Response Rate (ORR) by RECIST 1.1 (Phase 2)

Timeframe: Assessed pre-treatment, during treatment at 6- to 12-week intervals and post-treatment assessed up to 24 months.

Trial details

NCT IDNCT02759588

SponsorGenelux Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

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