A phase II trial of Atezolizumab for patients with unresectable alveolar soft tissue sarcoma - ALBERT trial

Yonemori Kan0 sites20 target enrollmentJune 1, 2020

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yonemori Kan

•1\) Patients must have histologically confirmed alveolar soft part sarcoma
•2\) Not curable by surgery
•3\) No symptomatic brain metastases, cancerous meningitis, spinal metastases requiring surgical intervention at the time of registration
•4\) No pericardial effusion, pleural effusion, or ascites with requiring treatment
•5\) Age at the time of registration is 16 years or older
•6\) ECOG performance status is 0 or 1
•7\) Having one or more measurable lesions confirmed by CT within 28 days before registration (Brain tumor must be confirmed by brain\-enhanced MRI)
•8\) No prior treatment with anti\-PD\-1 or anti\-PD\-L1 therapeutic antibody
•9\) Not received systemic administration of corticosteroids(Equivalent to prednisolone\> 10 mg / day) or immunosuppressant within 14 days before registration
•10\) Not received anti\-cancer drug or other study drug within 28 days before registration

•1\)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years).
•2\)Infection requiring systemic therapy.
•3\)Active gastrointestinal ulceration.
•4\)Current or previous interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings
•5\)Active radiation pneumonitis pneumonitis or Infectious pneumonia diagnosed based on imaging
•6\)Current or previous severe hypersensitive reaction to antibody drugs.
•7\)Active autoimmune disease or previous Chronic / recurrent autoimmune disease
•8\)HIV antibody\-positive, or HTLV\-1 antibody\-positive, or HBs antigen\-positive, or HCV antibody\-positive (those who are HCV\-RNA\-negative are not excluded even if HCV antibody\-positive)
•9\)Though HBs antigen\-negative, HBs antibody\-positive and/or HBc antibody\-positive, and HBV\-DNA quantitative test positive HBs
•10\)Pregnant or breast\-feeding women, or women suspected of being pregnant.