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Genentech YO39523/GOG 3015

Status:

Recruiting | Phase III

Official Title:

A Phase III, multicenter, randomized, study of Atezolizumab versus Placebo in combination with Paclitaxel, Carboplatin, and Bevacizumab for patients with newly diagnosed Stage III/IV Ovarian, Fallopian Tube, or Primary Peritoneal cancer

Study Purpose:

The purpose of this study is to research the effects, good or bad, of the drug Atezolizumab on your specific type of cancer (ovarian, fallopian tube, or primary peritoneal cancer).

Interventions:

  • Study agents: Paclitaxel, Carboplatin, Bevacizumab, Atezolizumab (or Placebo)
  • Quality of Life questionnaires
  • ARM A: TREATMENT PHASE Paclitaxel given IV (in a vein) every 3 weeks for 6 cycles, Carboplatin given IV every 3 weeks for 6 cycles, Bevacizumab given IV every 3 weeks for cycles 2-6, Atezolizumab  given IV every 3 weeks for 6 cycles  followed by: MAINTENANCE PHASE of Bevacizumab IV given every 3 weeks for cycles 7 – 22 plus Atezolizumab given IV for cycles 7 – 22
  • ARM B: TREATMENT PHASE Paclitaxel given IV (in a vein) every 3 weeks for 6 cycles, Carboplatin given IV every 3 weeks for 6 cycles, Bevacizumab given IV every 3 weeks for cycles 2-6, Placebo  given IV every 3 weeks for 6 cycles  followed by: MAINTENANCE PHASE of Bevacizumab IV given every 3 weeks for cycles 7 – 22 plus Placebo given IV for cycles 7 – 22

After completion of study therapy, patients are followed for at least 5 years.   

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

Diagnosis:

Stage IIIC to IV Epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer 

Eligibility:

Adequate organ function.

Negative Hepatitis B, Negative Hepatitis C, Negative HIV tests.

Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures.

Completion of patient questionnaires.

Life expectancy of greater than 12 weeks.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Genentech YO39523/GOG 3015

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!