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

Completed · Phase 3

Conditions studied: Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Gastric Cancer Third Line

In brief

The purpose of this study was 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.

Key facts

Study ID

NCT02625623

Run by

EMD Serono Research & Development Institute, Inc.

People needed

371

Starts

2015-12-28

Expected to finish

2019-11-13

Last updated by the study team

2020-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 neuropathy and 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

Where it is running

• Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350 — Pueblo, Colorado, United States
• Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E — Miami, Florida, United States
• Ocala Oncology Center, P.L. 433 S.W. 10th Street — Ocala, Florida, United States
• Florida Cancer Specialists 560 Jackson Street, Suite 220 — St. Petersburg, Florida, United States
• Ingalls Memorial Hospital One Ingalls Drive, W741 — Harvey, Illinois, United States
• Illinois Cancer Specialists 8915 W. Golf Rd. — Niles, Illinois, United States
• Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16 — Niles, Illinois, United States
• Carle Cancer Center 509 W. University Avenue — Urbana, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St — Topeka, Kansas, United States
• Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6 — Metairie, Louisiana, United States
• Henry Ford Health System 2799 West Grand Boulevard — Detroit, Michigan, United States
• Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200 — Minneapolis, Minnesota, United States
• Southern Nevada Cancer Research Foundation 601 S Rancho Drive — Las Vegas, Nevada, United States
• New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1 — Albany, New York, United States
• Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058 — Fargo, North Dakota, United States
• Northwest Cancer Specialists, P.C. 265 N Broadway — Portland, Oregon, United States
• Penn State University Milton S. Hershey Medical Center 500 University Drive — Hershey, Pennsylvania, United States
• Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor — Greenville, South Carolina, United States
• Tennessee Oncology 250 20th Ave North — Nashville, Tennessee, United States
• Texas Oncology Bedford 1609 Hospital Parkway — Bedford, Texas, United States
• Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400 — Dallas, Texas, United States
• Texas Oncology, P.A. - Denton 3720 South I-35 East — Denton, Texas, United States
• Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor — Houston, Texas, United States
• Texas Oncology, P.A. - McAllen 1901 South 2nd Street — McAllen, Texas, United States
• Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100 — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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