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GOG3015 - Atezo Frontline Study for Ovarian, Fallopian Tube or Primary Peritoneal Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about what effects adding atezolizumab to standard chemotherapy has on your specific type of cancer (ovarian, fallopian tube, or primary peritoneal).

What is the Condition Being Studied?

Newly diagnosed stage 3 or stage 4 ovarian, fallopian tube, or primary peritoneal cancer.

Who Can Participate in the Study?

Adult females who have been newly diagnosed with high grade epithelial stage 3 or stage 4 ovarian, fallopian tube, or primary peritoneal cancer.

Age Group
Adults

What is Involved?

This study starts with screening phase that includes tumor tissue testing, blood samples, CT scans, an EKG, and a visit with a Duke gynecologic oncologist. After the screening phase, you will be put into one of the following groups:
Group A: patients who have surgery to remove a tumor(s), but still have visible disease will be treated every 3 weeks for 6 cycles
Group B: patients who get chemotherapy before surgery to remove the tumor(s) will be treated every 3 weeks for 3 cycles before surgery and then another 3 cycles after surgery

Regardless of whether you are in Group A or B, you will be randomized (as in the flip of a coin) to one of the following treatment groups:
-- Standard chemotherapy (carboplatin, paclitaxel and bevacizumab) plus an investigational drug (atezolizumab) or
-- Standard chemotherapy (carboplatin, paclitaxel and bevacizumab) plus placebo

After 6 cycles, everyone will continue to bevacizumab, with or without atezolizumab for 16 more cycles (22 weeks)

Study Details

Full Title
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Principal Investigator
Gynecologic Cancers Specialist
Protocol Number
IRB:PRO00079784
NCT:NCT03038100
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698