CompletedNCT01666444Updated Sep 26, 2019Results posted

VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

A Phase 2 interventional study of pegylated liposomal doxorubicin (PLD) and VTX-2337 in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by Celgene. Completed at 136 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Celgene · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 297
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.

Read the detailed description

OBJECTIVES

Primary Objectives:

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.
To compare the progression-free survival (PFS) between the two treatment groups using Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST).

Secondary Objectives:

To compare the progression-free survival (PFS) between the two treatment groups using Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
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 and RECIST 1.1.
To compare the disease control rate (DCR) between the two treatment groups using irRECIST and RECIST 1.1.
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 and BRCA1/BRCA2 mutations 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 and micro RNA in primary tumor tissue (e.g. immune score), on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
To assess whether the presence of autoantibodies to tumor-derived proteins are predictive of 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

Conditions studied

Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer

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Keywords

recurrent epithelial ovarian cancer
recurrent fallopian tube cancer
recurrent primary peritoneal cavity cancer
ovarian serous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
ovarian clear cell cystadenocarcinoma
ovarian mixed epithelial carcinoma
Brenner tumor

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 297 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified.
Patient must have measurable disease as defined by RECIST 1.1.
Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease.
Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of recurrent or persistent disease.
Patients must have platinum-resistant disease, defined as having a platinum-free interval (PFI) of \< 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy.
Patients must have adequate bone marrow, renal, hepatic, and neurologic functions as defined by the following:
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets ≥ 100,000/mm3. Hemoglobin ≥ 9 g/dL.
- Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN).
- Hepatic function: bilirubin \< 1.2 mg/dL, SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy:
- Patients should be free of active infection requiring parenteral antibiotics.
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
- Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents, must be discontinued at least three weeks prior to registration.
- Any prior radiation therapy must be completed at least four weeks prior to registration.
Patients must have a GOG performance status of 0 or 1.
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
Patients must meet the entry requirements and undergo the baseline procedures.
Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information.

Exclusion criteria

Exclusion Criteria:

Patients who have had treatment with VTX-2337, doxorubicin, PLD, or any other anthracycline.
Patients who have received an investigational agent \< 30 days prior to registration.
Patients who have received oral or parenteral corticosteroids \< 2 weeks prior to registration or who require ongoing systemic immunosuppressive therapy for any reason.
Patients with active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last three years.
Patients who have received prior radiotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.
Patients who have received prior chemotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.
Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
Patients with clinically significant cardiovascular disease.
Patients who are pregnant or nursing.
Patients under the age of 18.
Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 297 participants (actual)

Study arms

Experimental
PLD 40 mg/m2 plus VTX-2337
The dosing schedule will be be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 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 on Day 3 only, without additional doses of VTX-2337 on Days 10 and Day 17.
Drug: pegylated liposomal doxorubicin (PLD) · Drug: VTX-2337
Active comparator
PLD 40 mg/m2 plus placebo
The dosing schedule will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus 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 placebo on Day 3 only.
Drug: pegylated liposomal doxorubicin (PLD) · Drug: Placebo

Interventions

Drugpegylated liposomal doxorubicin (PLD)
Also known as: Doxil, Lipodox
DrugVTX-2337
TLR8 Agonist
DrugPlacebo

What researchers measure

Primary outcomes

Overall Survival
Comparison of duration of survival between the 2 treatment groups
Time frame: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.

Secondary outcomes

Progression-free Survival (PFS)
Comparison of PFS between the 2 treatment groups
Time frame: Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.
Frequency and Severity of Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death
Time frame: Assessed during each cycle of therapy and within 30 days after the last cycle of therapy

Results

Posted Sep 26, 2019

Participant flow

Enrollment was initiated on 2012-Aug-13 and terminated on 2014-Apr-11. During this time, 297 patients were enrolled.

Participant flow — Overall Study
Milestone	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Started	149	148
Completed	147	147
Not completed	2	1
Withdrew: Did not initiate treatment	2	1

Outcome measures

PrimaryOverall Survival

Comparison of duration of survival between the 2 treatment groups

Time frame:: Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.
Reported as:: Median · days

Overall Survival
days	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Overall Survival	574 (242 to 1141)	552 (240 to 869)

Statistical analysis

Pegylated Liposomal Doxorubicin (PLD) + Placebo vs Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) · Log Rank · p = 0.923 (P-value is for a one-sided hypothesis test.) · Hazard ratio (hr): 1.22Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.

SecondaryProgression-free Survival (PFS)

Comparison of PFS between the 2 treatment groups

Time frame:: Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.
Reported as:: Median · days

Progression-free Survival (PFS)
days	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Progression-free Survival (PFS)	159 (87 to 351)	147 (85 to 267)

Statistical analysis

Pegylated Liposomal Doxorubicin (PLD) + Placebo vs Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) · Log Rank · p = 0.943 (P-value is for a one-sided hypothesis test.) · Hazard ratio (hr): 1.21The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).

SecondaryFrequency and Severity of Adverse Events (AEs)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death

Time frame:: Assessed during each cycle of therapy and within 30 days after the last cycle of therapy
Reported as:: Number · participants

Frequency and Severity of Adverse Events (AEs)
participants	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Grade 1	8	3
Grade 2	40	44
Grade 3	83	90
Grade 4	10	3
Grade 5	6	7

Adverse events

Collected over Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pegylated Liposomal Doxorubicin (PLD) + Placebo	—	30/147 (20.4%)	147/147 (100%)
Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	—	36/147 (24.5%)	147/147 (100%)

Most frequent serious events

Showing 10 of 69

Most frequent serious events
Event	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
NauseaGastrointestinal disorders	8/147	9/147
VomitingGastrointestinal disorders	5/147	7/147
Abdominal PainGastrointestinal disorders	3/147	6/147
SepsisInfections and infestations	5/147	1/147
DiarrheaGastrointestinal disorders	1/147	4/147
FatigueGeneral disorders	2/147	4/147
Creatinine IncreasedInvestigations	4/147	0/147
AnemiaBlood and lymphatic system disorders	3/147	2/147
Small Intestinal ObstructionGastrointestinal disorders	3/147	0/147
FeverGeneral disorders	1/147	3/147

Most frequent other events

Showing 10 of 317

Most frequent other events
Event	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
FatigueGeneral disorders	109/147	127/147
Injection Site ReactionGeneral disorders	13/147	107/147
AnemiaBlood and lymphatic system disorders	103/147	105/147
NauseaGastrointestinal disorders	93/147	97/147
ChillsGeneral disorders	25/147	92/147
White Blood Cell DecreasedInvestigations	83/147	74/147
ConstipationGastrointestinal disorders	75/147	79/147
VomitingGastrointestinal disorders	48/147	70/147
FeverGeneral disorders	19/147	70/147
Abdominal PainGastrointestinal disorders	54/147	61/147

Baseline characteristics

All enrolled patients

Age, Continuous
Age, Continuous(years)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
Median	61.6 (29.7 to 91.1)	63.5 (39.6 to 84.8)	62.7 (29.7 to 91.1)

Age, Customized
Age, Customized(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
<40 years	4	1	5
40-49 years	22	11	33
50-59 years	39	42	81
60-69 years	50	51	101
70-79 years	31	38	69
> 79 years	3	5	8

Sex: Female, Male
Sex: Female, Male(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
Female	149	148	297
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
Hispanic or Latino	4	3	7
Not Hispanic or Latino	143	145	288
Unknown or Not Reported	2	0	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
American Indian or Alaska Native	1	1	2
Asian	3	3	6
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	4	6	10
White	141	137	278
More than one race	0	0	0
Unknown or Not Reported	0	1	1

Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
0 = Fully active, no restrictions	104	105	209
1=Restricted activity;ambulatory;can do light work	45	43	88

Prior Platinum-Free Interval as per Case Report Forms
Prior Platinum-Free Interval as per Case Report Forms(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
<= 6 months	79	72	151
> 6 months	70	76	146

Prior Chemotherapy Regimens
Prior Chemotherapy Regimens(Participants)	Pegylated Liposomal Doxorubicin (PLD) + Placebo	Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)	Total
1	81	69	150
2	64	74	138
3	4	5	9

Study locations

136 sites

St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013, United States
Winthrop P. Rockefeller Cancer Institute - University of Arkansas
Little Rock, Arkansas 72205, United States
Providence Saint Joseph Medical Center
Burbank, California 91505, United States
Kaiser Permanente Medical Center
Hayward, California 94545, United States
Long Beach Memorial Medical Center
Long Beach, California 90806, United States
Kaiser Permanente Medical Center
Oakland, California 94611, United States
Kaiser Permanente Medical Center
Roseville, California 95661, United States
Sutter Cancer Center
Sacramento, California 95816, United States
Kaiser Permanente Medical Center
Sacramento, California 95825, United States
Kaiser Permanente Medical Center
San Francisco, California 94115, United States
Kaiser Permanente Medical Center
San Jose, California 95119, United States
Kaiser Permanente Medical Center
Santa Clara, California 95051, United States
Kaiser Permanente Medical Center
South San Francisco, California 94080, United States
Stanford University School of Medicine
Stanford, California 94305, United States
Kaiser Permanente Medical Center
Vallejo, California 94586, United States
Kaiser Permanente Medical Center
Walnut Creek, California 94596, United States
University of Colorado Cancer Center
Aurora, Colorado 80045, United States
Hartford Hospital
Hartford, Connecticut 06102, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut 06050, United States
Yale - New Haven Hospital
New Haven, Connecticut 06520, United States
MD Anderson Cancer Center - Orlando
Orlando, Florida 32806, United States
Women's Cancer Associates
Saint Petersburg, Florida 33701, United States
Northside Hospital
Atlanta, Georgia 30342, United States
Georgia Regents University
Augusta, Georgia 30912, United States
Northeast Georgia Medical Center
Gainesville, Georgia 30501, United States
Central Georgia Gynecologic Oncology
Macon, Georgia 31201, United States
Memorial Health University Medical Center
Savannah, Georgia 31404, United States
St. Joseph's - Candler Gynecologic Oncology
Savannah, Georgia 31405, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois 60611, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
Sudarshan K. Sharma, MD, LTD
Hinsdale, Illinois 60521, United States
Carle Cancer Center
Urbana, Illinois 61801, United States
Indiana University Medical Center
Indianapolis, Indiana 46202, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana 46260, United States
McFarland Clinic
Ames, Iowa 50010, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242, United States
University of Kansas Medical Center
Westwood, Kansas 66205, United States
Maine Medical Partners Women's Health
Scarborough, Maine 04074, United States
University of Maryland Medical Center
Baltimore, Maryland 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland 21204, United States
Sinai Hospital of Baltimore
Baltimore, Maryland 21215, United States
Johns Hopkins Medical Institution
Baltimore, Maryland 21287, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805, United States
University of Massachusetts Memorial Healthcare
Worcester, Massachusetts 01605, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan 48106, United States
Bronson Battle Creek
Battle Creek, Michigan 49017, United States
Karmanos Cancer Institute - Wayne State University
Detroit, Michigan 48201, United States
Henry Ford Health System
Detroit, Michigan 48202, United States
Grand Rapids Clinical Oncology
Grand Rapids, Michigan 49503, United States
Saint Mary's Health Care
Grand Rapids, Michigan 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503, United States
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan 49546, United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007, United States
Mercy Health Partners - Mercy Campus
Muskegon, Michigan 49444, United States
Reed City Hospital - Spectrum Health
Reed City, Michigan 49677, United States
Munson Medical Center
Traverse City, Michigan 49684, United States
Minnesota Oncology Coon Rapids Clinic
Coon Rapids, Minnesota 55433, United States
Fairview Southdale Hospital
Edina, Minnesota 55435, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota 55404, United States
Metro Minnesota Clinical Oncology Program
Saint Louis Park, Minnesota 55416, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota 55426, United States
Minnesota Oncology Hematology - St. Paul Cancer Center
Saint Paul, Minnesota 55102, United States
Woodbury Clinic - CornerStone Medical Specialty Centre
Woodbury, Minnesota 55125, United States
St. Dominic-Jackson Memorial Hospital
Jackson, Mississippi 32916, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
Ellis Fischel Cancer Center - University of Missouri
Columbia, Missouri 65211, United States
Women's Cancer Care Center of Nevada
Las Vegas, Nevada 89169, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Cooper University Hospital
Camden, New Jersey 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey 07601, United States
Southwest Gynecologic Oncology Associates
Albuquerque, New Mexico 87016, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106, United States
Memorial Medical Center
Las Cruces, New Mexico 88011, United States
Women's Cancer Care Associates
Albany, New York 12208, United States
SUNY Downstate Medical Center
Brooklyn, New York 11203, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
Monter Cancer Center
Lake Success, New York 11042, United States
North Shore University Hospital
Manhasset, New York 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040, United States
NYU Langone Medical Center - Cancer Institute
New York, New York 10016, United States
Columbia University Medical Center
New York, New York 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
Gynecologic Oncology of Central New York - SUNY Upstate
Syracuse, New York 13057, United States
Hope Women's Cancer Center
Asheville, North Carolina 28806, United States
Alamance Regional Cancer Center
Burlington, North Carolina 27215, United States
Carolinas Medical Center / Levine Cancer Institute
Charlotte, North Carolina 28204, United States
Carolinas Medical Center - Northeast
Concord, North Carolina 28025, United States
Wake Forest University Health Science
Winston-Salem, North Carolina 27157, United States
Summa Health System
Akron, Ohio 44304, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
University Hospitals of Cleveland
Cleveland, Ohio 44106, United States
Fairview Hospital Moll Pavilion Cancer Center
Cleveland, Ohio 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195, United States
Ohio State University Medical Center
Columbus, Ohio 43210, United States
Women's Cancer Center at Kettering Medical Center
Kettering, Ohio 45429, United States
Hillcrest Hospital - Cleveland Clinic
Mayfield Heights, Ohio 44124, United States
Lake University Seidman Cancer Center
Mentor, Ohio 44060, United States
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma 73104, United States

Showing the first 100 of 136 sites.

References and documents

Publications

Monk BJ, Brady MF, Aghajanian C, Lankes HA, Rizack T, Leach J, Fowler JM, Higgins R, Hanjani P, Morgan M, Edwards R, Bradley W, Kolevska T, Foukas P, Swisher EM, Anderson KS, Gottardo R, Bryan JK, Newkirk M, Manjarrez KL, Mannel RS, Hershberg RM, Coukos G. A phase 2, randomized, double-blind, placebo- controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a Gynecologic Oncology Group partners study. Ann Oncol. 2017 May 1;28(5):996-1004. doi: 10.1093/annonc/mdx049. PubMed 28453702 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01666444
Lead sponsor: Celgene
Collaborators: Gynecologic Oncology Group
Responsible party: Sponsor
First posted: Aug 16, 2012
Start date: Oct 31, 2012
Primary completion: Jul 31, 2016
Completion: Jul 31, 2016
Results posted: Sep 26, 2019
Last update: Sep 26, 2019

Study contacts

Bradley J. Monk, MD

study chair · St. Joseph's Hospital and Medical Center, Phoenix AZ

Amar Patel, MD

study director · Celgene

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Ovarian Neoplasms→

Other studies from this sponsor

Celgene

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