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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02580058




Registration number
NCT02580058
Ethics application status
Date submitted
16/10/2015
Date registered
20/10/2015
Date last updated
11/06/2019

Titles & IDs
Public title
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)
Scientific title
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
Secondary ID [1] 0 0
2015-003091-77
Secondary ID [2] 0 0
B9991009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - avelumab
Treatment: Drugs - PLD

Experimental: avelumab - Arm A: avelumab alone

Experimental: avelumab plus pegylated liposomal doxorubicin (PLD) - Arm B: avelumab plus PLD

Active Comparator: PLD - Arm C: PLD alone


Other interventions: avelumab
10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles

Treatment: Drugs: 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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Timepoint [1] 0 0
randomization up to approximately 20 months
Primary outcome [2] 0 0
Progression Free Survival (PFS) - To demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Progression Free Survival (PFS) in patients with platinum resistant/platinum refractory ovarian cancer.
Timepoint [2] 0 0
randomization up to approximately 20 months
Secondary outcome [1] 0 0
OR (Objective Response) - Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study =4 weeks after initial documentation of response.
Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as =30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.
Timepoint [1] 0 0
Baseline up to approximately 20 months
Secondary outcome [2] 0 0
PFS (Progression Free Survival) - The period from study entry until disease progression, death or date of last contact.
Timepoint [2] 0 0
randomization up to approximately 20 months
Secondary outcome [3] 0 0
DR (Duration of Response) - Duration of response (DR) is defined, for patients with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
Timepoint [3] 0 0
first documentation of objective tumor response up to approximately 20 months
Secondary outcome [4] 0 0
DC (Disease Control) - Defined as complete response (CR), partial response (PR), or stable disease (SD) 24 weeks according to the RECIST version 1.1 recorded from randomization until disease progression or death due to any cause. The DC rate (DCR) on each randomized treatment arm will be estimated by dividing the number of patients with CR, PR, or SD 24 weeks by the number of patients randomized to the treatment arm. The corresponding exact 2 sided 95% CI for the DC rates will be provided by treatment arm
Timepoint [4] 0 0
Randomization up to approximately 20 months
Secondary outcome [5] 0 0
Ctrough for avelumab - Ctrough is defined as the trough plasma concentrate at the end of an avelumab interval
Timepoint [5] 0 0
pre dose and at the end of infusion (immediately before the end of avelumab infusion) on Days 1 and 15.
Secondary outcome [6] 0 0
Cmax for avelumab - Cmax defined as the maximum plasma concentration of avelumab
Timepoint [6] 0 0
pre dose and at the end of infusion (immediately before the end of avelumab infusion) on Days 1 and 15.
Secondary outcome [7] 0 0
Cmax for PLD - Cmax defined as the maximum plasma concentration of PLD
Timepoint [7] 0 0
in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose.
Secondary outcome [8] 0 0
Vd (volume of distribution) for PLD - Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Timepoint [8] 0 0
in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose.
Secondary outcome [9] 0 0
CL (clearance) for PLD - CL is a quantitative measure of the rate at which PLD is removed from the body
Timepoint [9] 0 0
in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose.
Secondary outcome [10] 0 0
AUC (area under the concentration time curve) for PLD - AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption
Timepoint [10] 0 0
in the first 12 patients pre dose, immediately prior to end of infusion, and at 2, 6, 24, and 336 hours (Day 15) post start infusion of PLD on Day 1 of next dose.
Secondary outcome [11] 0 0
Incidence of Anti-Drug Antibody (ADA) - immunogenicity assessment for avelumab
Timepoint [11] 0 0
prior to start of avelumab infusion on Day 1 and at end of treatment for up to 24 months.
Secondary outcome [12] 0 0
EORTC QLQ C30 - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire: 30 question survey and includes 5 functional domain subscales, including a physical functioning sub scale, a role functioning subscale, an emotional functioning sub scale, a cognitive functioning sub scale and a social functioning subscale. Higher scores on the functioning domains are indicative of higher levels of functioning
Timepoint [12] 0 0
once a month before dosing, up to 24 months
Secondary outcome [13] 0 0
EORTC QLQ OV28 - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire: 28 item instrument with seven (7) functional domain subscales. The 7 subscales include: (i) an abdominal/gastrointestinal symptom subscale (7 items); (ii) a peripheral neuropathy subscale (3 items); (iii) an other chemotherapy side effects subscale (7 items); (iv) a hormonal/menopausal symptoms subscale (2 items); (v) a body image subscale (2 items); (vi) an attitude to disease and treatment subscale (3 items) and (vii) a sexual function subscale (4 items)
Timepoint [13] 0 0
once a month before dosing, up to 24 months
Secondary outcome [14] 0 0
FOSI - a very brief ovarian cancer symptom index derived from the FACT O (ie, Functional Assessment of Cancer Therapy Ovarian) to measure symptom response to treatment for ovarian cancer. The 8 item FOSI includes items assessing worry about future deterioration, contentment with QoL, and lack of energy in addition to 5 questions to assess GI related symptoms
Timepoint [14] 0 0
once a month before dosing, up to 24 months
Secondary outcome [15] 0 0
EuroQoL EQ 5D - Euro Quality of Life: 6 item patient completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components to the EuroQol EQ 5D: a Health State Profile which has individuals rate their level of problems (no, some or moderate, extreme) in 5 areas (mobility, self care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights are available that allow for the creation of a single summary score. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction
Timepoint [15] 0 0
once a month before dosing, up to 24 months
Secondary outcome [16] 0 0
Tumor Tissue Biomarkers - May include but not limited to PD L1 expression and tumor infiltrating CD8+ T lymphocytes by IHC, and/or tissue expression of FoxP3, PD 1, PD L2
Timepoint [16] 0 0
Baseline, optional sample at disease progression
Secondary outcome [17] 0 0
Nab (neutralizing antibodies) against avelumab - immunogenicity assessment for avelumab
Timepoint [17] 0 0
performed if ADA is positive: prior to start of avelumab infusion on Day 1 and at end of treatment for up to 24 months.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Epic Pharmacy,Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Newcastle Private Hospital Pty Limited - Newcastle
Recruitment hospital [3] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [4] 0 0
Rivercity Pharmacy - Auchenflower
Recruitment hospital [5] 0 0
Mater Pharmacy Services - Brisbane
Recruitment hospital [6] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [7] 0 0
Clinical Research Unit - Herston
Recruitment hospital [8] 0 0
Metro North Hospital and Health Service - Herston
Recruitment hospital [9] 0 0
Oncology Pharmacy - Herston
Recruitment hospital [10] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [11] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [12] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [13] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [14] 0 0
Cabrini Health Limited - Brighton
Recruitment hospital [15] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [16] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [18] 0 0
Pharmacy Department - Parkville
Recruitment hospital [19] 0 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
3186 - Brighton
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3144 - Malvern
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3052 - Parkville
Recruitment outside Australia
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Taoyuan City
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United Kingdom
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Cambridgeshire
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CITY OF Glasgow
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Merseyside
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Middlesex
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Oxford
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Surrey
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Glasgow
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Manchester
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Nottingham
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Stockport

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02580058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications