A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
OBJECTIVES
Primary Objective:
To compare the overall survival (OS) of patients treated with VTX-2337 + PLD versus those
treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian
tube or primary peritoneal cancer.
Secondary Objectives:
- To compare the progression-free survival (PFS) between the two treatment groups using
Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST).
- To compare the nature, frequency and severity of drug-related adverse events (AEs)
between the two treatment groups.
Exploratory Objectives:
- To compare the best overall response rate (ORR) and duration of response (based on the
probability of being in response function [PBRF]) between the two treatment groups
using irRECIST.
- To compare the disease control rate (DCR) between the two treatment groups using
irRECIST.
- To assess the impact of immune status and response on the clinical effects (OS, PFS,
DCR, ORR, PBRF, AEs) of study treatment.
- To assess the effect of TLR8 polymorphisms on the clinical effects (OS, PFS, DCR, ORR,
PBRF, AEs) of study treatment.
- To assess the effect of immune cell subsets, as measured by immunohistochemistry in
primary tumor tissue (e.g. immune score), on the clinical effects (OS, PFS, DCR, ORR,
PBRF, AEs) of study treatment.
OUTLINE:
This is Phase 2 multicenter clinical study to evaluate the efficacy and safety of the
combination of VTX-2337 + PLD compared to PLD + Placebo.
The dosing schedule will be the same for both treatment arms, and will be based on a 28-day
cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 or placebo on Day 3, Day 10,
and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on
Day 1 plus VTX-2337 or placebo on Day 3.
Blood samples are collected periodically during cycle 1 for pharmacodynamics,
pharmacogenomics, and other research studies.
Patients will receive therapy until disease progression based on Immune-Related RECIST or
until adverse effects prohibit further therapy. Following treatment completion, all patients
will be followed with physical exams and histories every three months for the first two
years, and then every six months for the next three years, and then
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival (OS) of patients treated with VTX-2337 + PLD versus those treated with PLD alone
Overall Survival analysis will occur when 146 deaths have occurred.
Approximately 15 months after the last patient is randomized.
No
Bradley J. Monk, MD
Study Chair
St. Joseph's Hospital and Medical Center, Phoenix AZ
United States: Food and Drug Administration
GOG-3003
NCT01666444
October 2012
June 2016
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Long Beach Memorial Medical Center | Long Beach, California 90806 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Summa Health System | Akron, Ohio 44312 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
St. Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Carle Cancer Center | Urbana, Illinois 61801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
Henry Ford Health System | Detroit, Michigan 48202 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
University of Colorado Denver | Denver, Colorado 80262 |
St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Gynecologic Oncology of West Michigan | Grand Rapids, Michigan 49546 |
Women's Cancer Care Associates | Albany, New York 12208 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
McFarland Clinic | Ames, Iowa 50010 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Carolinas Medical Center - Northeast | Concord, North Carolina 28025 |
Abbott Northwestern Hospital | Minneapolis, Minnesota 55430 |
University of Wisconsin-Madison | Madison, Wisconsin 53792 |
Southwest Gynecologic Oncology Associates | Albuquerque, New Mexico 87106 |
Alamance Regional Cancer Center | Burlington, North Carolina 27215 |
Park Nicollet Frauenshuh Cancer Center | Minneapolis, Minnesota 55416 |
Peggy and Charles Stephenson Cancer Center | Oklahoma City, Oklahoma 73104 |
Bon Secours St. Francis Hospital | Greenville, South Carolina 29601 |
Tulsa Cancer Institute | Tulsa, Oklahoma 74136 |
Sudarshan K. Sharma, MD, LTD | Hinsdale, Illinois 60521 |
Minnesota Oncology Coon Rapids Clinic | Coon Rapids, Minnesota 55433 |
Metro Minnesota Clinical Oncology Program | St. Louis Park, Minnesota 55416 |
Minnesota Oncology St. Paul Cancer Center | St. Paul, Minnesota 55102 |
Woodbury Clinic - CornerStone Medical Specialty Centre | Woodbury, Minnesota 55125 |
St. Dominic-Jackson Memorial Hospital | Jackson, Mississippi 32916 |
Women's Cancer Care Center of Nevada | Las Vegas, Nevada 89169 |
Cooper Health System / Cooper Cancer Institute | Camden, New Jersey 08103 |
Carolinas Medical Center / Levine Cancer Institute | Charlotte, North Carolina 28204 |
Women's Cancer Center at Kettering Medical Center | Kettering, Ohio 45429 |
Lake University Seidman Cancer Center | Mentor, Ohio 44060 |
Abington Memorial Hospital; Hanjani Institute for Gynecologic Oncology | Abington, Pennsylvania 19001 |
Reading Hospital (McGlinn Family Regional Cancer Center) | West Reading, Pennsylvania 19611 |
Mid Atlantic Pelvic Surgery Associates | Annandale, Virginia 22003 |