NCCH1907/MK008 trial

JRCT ID: jRCT2031200041

Registered date:01/06/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: unresectable alveolar soft tissue sarcoma
• Date of first enrollment: 28/05/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): An intravenous injection of Atezolizumab (15mg/kg/body for patients under 18 years old, 1200mg/body for other patients, once in every three weeks)

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: objective response rate, progression free survival, overall survival, incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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
11) Not received operation under general anesthesia within 28 days before registration
12) Not received radiation therapy within 28 days before registration
13) Not received radiopharmaceutical within 56 days before registration
14) Having all laboratory tests performed within 14 days before registration are the values are within the following range.Patients should not receive administration of G-CSF and/or blood transfusion within 14 days before the blood collection
(1) Neutrophil count => 1,000/mm3
(2) Platelet count => 10.0 x 104/mm3
(3) Hemoglobin => 8.0 g/dL
(4) AST <= 100 U/L (allow AST <= 150 U/L with liver metastasis)
(5) ALT <= 100 U/L (allow ALT <= 150 U/L with liver metastasis)
(6) Total bilirubin <= 1.5 mg/dL
(7) Creatinine <= 1.5 mg/dL
15) => 92% of SpO2 under room air conditions within 14 days before registration
16) Consent to contraception and limited breast-feeding
17) Written informed consent.

Exclude criteria

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.
11)Psychiatric diseases or psychological symptoms interfering with participation in the trial.

Related Information

• Primary Sponsor: Yonemori Kan
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd.