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Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

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ClinicalTrials.gov Identifier: NCT02625623
Recruitment Status : Active, not recruiting
First Posted : December 9, 2015
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

December 4, 2015
December 9, 2015
April 10, 2018
December 28, 2015
September 14, 2017   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
Time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death
Overall Survival [ Time Frame: Time from date of randomization until death, assessed up to 3 years ]
Time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Complete list of historical versions of study NCT02625623 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
    PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS will be assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD is defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
  • Best Overall Response (BOR) [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
    BOR will be determined according to RECIST 1.1 and as adjudicated by an Independent Review Committee (IRC). BOR is defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
  • Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
    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).
  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
    EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer subjects. 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 GHS/QoL score ranges from 0 to 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.
  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC STO22) Questionnaire Scores [ Time Frame: Until 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized (assessed up to 2 years) ]
    The QLQ-STO22 is a gastric cancer quality of life 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.
  • Progression Free Survival (PFS) [ Time Frame: Time from date of randomization until PD or death, assessed up to 3 years ]
    PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS will be assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD is defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
  • Best Overall Response (BOR) [ Time Frame: Time from date of randomization up to 3 years ]
    BOR will be determined according to RECIST 1.1 and as adjudicated by an Independent Review Committee (IRC). BOR is defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
  • Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire [ Time Frame: Baseline up to 3 years ]
    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).
  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status [ Time Frame: Baseline up to 3 years ]
    EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer subjects. 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 GHS/QoL score ranges from 0 to 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.
  • Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC STO22) Questionnaire Scores [ Time Frame: Baseline up to 3 years ]
    The QLQ-STO22 is a gastric cancer quality of life 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.
Not Provided
Not Provided
 
Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
The purpose of this study is to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer Third Line
  • Drug: Avelumab
    Avelumab will be administered as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with best supportive care (BSC).
    Other Names:
    • MSB0010718C
    • Anti PD-L1
  • Drug: Irinotecan
    Irinotecan will be administered at a dose of 150 mg/m ^2 on Day 1 and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
  • Drug: Paclitaxel
    Paclitaxel will be administered at a dose of 80 mg/m^2 on Day 1, 8, and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
  • Other: Best Supportive Care (BSC)
    BSC is defined as treatment administered with the intent to maximize Quality of life without a specific antineoplastic regimen and is based on investigator's discretion. BSC will be administered once every 3 weeks.
  • Experimental: Avelumab+Best Supportive Care (BSC)
    Interventions:
    • Drug: Avelumab
    • Other: Best Supportive Care (BSC)
  • Active Comparator: Physician's choice chemotherapy+BSC or BSC alone

    Physician's choice chemotherapy comprises of the following:

    Paclitaxel or

    Irinotecan

    Subjects who are not deemed eligible to receive Paclitaxel or Irinotecan at the dose and schedule specified will receive BSC as per investigator discretion and visit the clinic once every 3 weeks.

    Interventions:
    • Drug: Irinotecan
    • Drug: Paclitaxel
    • Other: Best Supportive Care (BSC)
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
371
330
September 30, 2022
September 14, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged greater than or equal to (>=) 18 years
  • Subjects with histologically confirmed recurrent unresectable, recurrent locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
  • Availability of a formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue
  • Subjects must have received 2 prior courses of systemic treatment for unresectable, recurrent, locally advanced or metastatic gastric cancer, and must have progressed after the second line
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at trial entry
  • Adequate hematological, 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

Exclusion Criteria:

  • Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
  • Concurrent anticancer treatment
  • Major surgery
  • 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 less than [<] 10 mg prednisone daily).
  • All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, 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 of grade >2 related to prior therapy except alopecia
  • Neuropathy Grade greater than or equal (>=) 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 within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
  • Legal incapacity or limited legal capacity
  • Subjects will be excluded from the treatment with irinotecan or paclitaxel monotherapy if administration of their chemotherapy would be inconsistent with the current local labeling (for example, in regard to contraindications, warnings/precautions, or special provisions) for that chemotherapy. Investigators should check updated labeling via relevant websites before randomization
  • Subjects should start treatment administration within 28 days after signing the informed consent form (ICF). Treatment administration will start within 4 days after the randomization call
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Spain,   United States
Czech Republic
 
NCT02625623
EMR 100070-008
2015-003301-42 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
EMD Serono ( EMD Serono Research & Development Institute, Inc. )
EMD Serono Research & Development Institute, Inc.
Merck KGaA
Study Director: Medical Responsible EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
EMD Serono
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP