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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02625610




Registration number
NCT02625610
Ethics application status
Date submitted
4/12/2015
Date registered
9/12/2015
Date last updated
22/05/2019

Titles & IDs
Public title
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Scientific title
A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction
Secondary ID [1] 0 0
2015-003300-23
Secondary ID [2] 0 0
EMR 100070-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Capecitabine
Other interventions - Best supportive care
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Capecitabine

Experimental: Avelumab - Induction Phase: Subjects will be administered with oxaliplatin and either 5-Fluorouracil (5-FU) or capecitabine for 12 weeks.
Maintenance Phase: Subjects will be administered with intravenous (IV) infusion of avelumab once every 2 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Active Comparator: Oxaliplatin-fluoropyrimidine doublet - Induction Phase: Subjects will be administered with oxaliplatin and either 5-FU or capecitabine for 12 weeks.
Maintenance Phase: Subjects will continue the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5-FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Subjects who are not deemed eligible to receive further chemotherapy will receive best supportive care (BSC) alone with no active therapy.


Treatment: Drugs: Avelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.

Treatment: Drugs: Oxaliplatin
Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.
Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: 5-Fluorouracil
Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: Leucovorin
Induction Phase: Leucovorin will be administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.
Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: Capecitabine
Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.
Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Other interventions: Best supportive care
Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care will be administered per institutional guidelines and subjects will visit the clinic every 3 weeks.

Treatment: Drugs: Oxaliplatin
Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.

Treatment: Drugs: 5-Fluorouracil
Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks.

Treatment: Drugs: Leucovorin
Induction Phase: Leucovorin will be administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.

Treatment: Drugs: Capecitabine
Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Timepoint [1] 0 0
From the start of randomization to a minimum of 36 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.
Timepoint [1] 0 0
From the start of randomization to a minimum of 36 months
Secondary outcome [2] 0 0
Best Overall Response (BOR) in Maintenance Phase - BOR will be determined according to RECIST 1.1 per investigator assessment, and statistically evaluated as the objective response rate (ORR). The ORR is defined as the proportion of all randomized subjects with a confirmed BOR of partial response (PR) or complete response (CR) according to RECIST 1.1, as per Investigator assessment. BOR is defined as the best response of any of the CR, PR, stable disease (SD) and progressive disease (PD) recorded from the date of randomization until PD or recurrence (taking the smallest measurement recorded since the start of treatment as reference).
Timepoint [2] 0 0
From the start of randomization to a minimum of 36 months
Secondary outcome [3] 0 0
Change From Baseline in European Quality Of Life 5-dimensions-5 Levels (EQ-5D-5L) Health Outcome Questionnaire - The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
Timepoint [3] 0 0
From re-baseline to a minimum of 36 months
Secondary outcome [4] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) - The European Organization for Research and Treatment of Cancer (EORTC) Core QoL questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 Global Health Status/QoL scale is scored between 0 and 100. High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Timepoint [4] 0 0
From re-baseline to a minimum of 36 months
Secondary outcome [5] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Gastric Cancer Module QLQ-STO22 - The QLQ-STO22 is a gastric cancer quality of life (QoL) questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). For the symptom scales or single items, participants will be assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.
Timepoint [5] 0 0
From re-baseline to a minimum of 36 months
Secondary outcome [6] 0 0
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 - TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Timepoint [6] 0 0
From the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 3 years

Eligibility
Key inclusion criteria
- Male or female subjects aged greater than or equal to (>=) 18 years

- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST 1.1)

- Subjects with histologically confirmed unresectable locally advanced or metastatic
adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial
entry

- Estimated life expectancy of more than 12 weeks

- Adequate haematological, hepatic and renal functions defined by the protocol

- Negative blood pregnancy test at Screening for women of childbearing potential

- Highly effective contraception for both male and female subjects if the risk of
conception exists

- Other protocol defined inclusion criteria could apply
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior therapy with any antibody or drug targeting T-cell coregulatory proteins

- Concurrent anticancer treatment or immunosuppressive agents

- Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of
the stomach or gastro-esophageal junction (GEJ)

- Tumor shown to be human epidermal growth factor 2 plus (HER2+)

- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment
and/or if the subject has not fully recovered from the surgery within 4 weeks of
enrolment

- Subjects receiving immunosuppressive agents (such as steroids) for any reason should
be tapered off these drugs before initiation of the trial treatment (with the
exception of subjects with adrenal insufficiency, who may continue corticosteroids at
physiologic replacement dose, equivalent to <= 10 mg prednisone daily).

- All subjects with brain metastases, except those meeting the following criteria: a.
Brain metastases have been treated locally, have not been progressing at least 2
months after completion of therapy, and no steroid maintenance therapy is required,
and b. No ongoing neurological symptoms that are related to the brain localization of
the disease (sequelae that are a consequence of the treatment of the brain metastases
are acceptable)

- Previous malignant disease (other than gastric cancer) within the last 5 years with
the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ
(bladder, cervical, colorectal, breast)

- Prior organ transplantation, including allogeneic stem-cell transplantation

- Significant acute or chronic infections

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent

- Known severe hypersensitivity reactions to monoclonal antibodies, any history of
anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially
controlled asthma)

- Persisting toxicity related to prior therapy except alopecia

- Neuropathy Grade > 3

- Pregnancy or lactation

- Known alcohol or drug abuse

- History of uncontrolled intercurrent illness including hypertension, active infection,
diabetes

- Clinically significant (i.e., active) cardiovascular disease

- All other significant diseases might impair the subject's tolerance of trial treatment

- Any psychiatric condition that would prohibit the understanding or rendering of
informed consent and that would limit compliance with study requirements

- Vaccination with live or live/attenuated viruses within 55 days of the first dose of
avelumab and while on trial is prohibited except for administration of inactivated
vaccines

- Legal incapacity or limited legal capacity

- Patients will be excluded from the Induction Phase and the Maintenance Phase if
administration of their chemotherapy would be inconsistent with the current local
labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or
special provisions) for that chemotherapy. Investigators should check updated
labelling via relevant websites at the time of entry into the Induction Phase and the
Maintenance Phase

- Other protocol defined exclusion criteria could apply

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,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
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Greenslopes Private Hospital - Greenslopes
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Royal Brisbane and Women's Hospital - Herston
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Flinders Medical Centre - Bedford Park
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Lyell McEwin Hospital - Elizabeth Vale
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Royal Hobart Hospital - Hobart
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Ballarat Base Hospital - Ballarat
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Bendigo Hospital - Bendigo
Recruitment hospital [10] 0 0
Monash Medical Centre Clayton - Bentleigh
Recruitment hospital [11] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [14] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
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4120 - Greenslopes
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4006 - Herston
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
3550 - Bendigo
Recruitment postcode(s) [10] 0 0
8120 - Bentleigh
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3690 - Wodonga
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
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State/province [1] 0 0
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Country [124] 0 0
United Kingdom
State/province [124] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate superiority of treatment with avelumab versus
continuation of first-line chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT02625610
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany
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