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A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Last updated on August 15, 2018

FOR MORE INFORMATION
Study Location
Arizona Oncology Associates, PC - HAL
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer.

- Platinum resistant/refractory disease, defined as disease progression within 180 days
following the last administered dose of platinum therapy (resistant), or lack of
response or disease progression while receiving the most recent platinum based
therapy (refractory), respectively.

- Received up to 3 lines of chemotherapy for platinum sensitive disease, most recently
platinum containing, and no prior therapy for platinum resistant disease.

- Measurable disease by investigator assessment with at least 1 unidimensional
measurable lesion by RECIST v.1.1 that has not previously been irradiated.

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid
disease not requiring immunosuppressive treatment are eligible.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Non epithelial tumor, including malignant mixed Müllerian tumors without high grade
serous component, or ovarian tumors with low malignant potential (ie, borderline
tumors).

- Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti
cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab,
tremelimumab or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways).

- Known symptomatic brain metastases requiring steroids. Patients with previously
diagnosed brain metastases are eligible if they have completed their treatment and
have recovered from the acute effects of radiation therapy or surgery prior to study
entry, have discontinued corticosteroid treatment for these metastases for at least 4
weeks prior to study entry and are neurologically stable.

- Diagnosis of any other malignancy within 5 years prior to registration, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the breast or of the cervix.

- Severe gastrointestinal conditions such as clinical or radiological evidence of bowel
obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4
weeks prior to enrollment, or history of inflammatory bowel disease.

NCT02580058
Pfizer
Active, not recruiting
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

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A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
A Phase 3, Multicenter, Randomized, Open-label Study Of Avelumab (msb0010718c) Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum-resistant/Refractory Ovarian Cancer
A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Biological: avelumab
    10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
  • Drug: PLD
    PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
    Other Name: doxorubicin, calyx
  • Experimental: avelumab
    Arm A: avelumab alone
    Intervention: Biological: avelumab
  • Experimental: avelumab plus pegylated liposomal doxorubicin (PLD)
    Arm B: avelumab plus PLD
    Interventions:
    • Biological: avelumab
    • Drug: PLD
  • Active Comparator: PLD
    Arm C: PLD alone
    Intervention: Drug: PLD
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
546
March 12, 2018
March 12, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
  • Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
  • Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
  • Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

Exclusion Criteria:

  • Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
  • Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
  • Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
  • Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
  • Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT02580058
B9991009
2015-003091-77 ( EudraCT Number )
JAVELIN OVARIAN 200 ( Other Identifier: Alias Study Number )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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