This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions \>=4 weeks apart), as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 5 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 5 years
Disease Contral Rate (DCR)
DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time frame: Up to approximately 5 years
6-Month PFS Rate
6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.
Time frame: Up to 6 month
Overall Survival (OS)
OS after start of treatment is defined as the time from start of treatment to death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
Abemaciclib will be administered by mouth twice a day during each 28-day cycle
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)
Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
UCSF Helen Diller Family CCC
San Francisco, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Cabrini Hospital
Malvern, Victoria, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
...and 31 more locations
Time frame: Up to approximately 5 years
Confirmed ORR as Determined by IRC (Independent Review Committee)
Confirmed ORR, as determined by the IRC according to RECIST v1.1.
Time frame: Up to approximately 5 years
DOR as Determined by IRC
DOR, as determined by the IRC according to RECIST v1.1
Time frame: Up to approximately 5 years
DCR as Determined by IRC
DCR, as determined by the IRC according to RECIST v1.1
Time frame: Up to approximately 5 years
PFS as Determined by IRC
PFS, as determined by the IRC according to RECIST v1.1
Time frame: Up to approximately 5 years
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Time frame: Up to approximately 5 years