Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously As a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic malignancies

Phase 1

• Conditions: Advanced or Metastatic Solid Tumors or Hematologic Malignancies; MedDRA version: 18.1Level: LLTClassification code 10029000Term: Neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001422-23-GB
• Lead Sponsor: Genentech Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Study Completion: 2018-09-30
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

• Age = 18 years
• Histologically or cytologically documented, incurable or metastatic solid malignancy that is advanced (non -resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists. Tumor type-specific criteria are detailed in Appendix G.
• Representative tumor specimens in paraffin blocks/unstained slides with an associated pathology report
• Adequate hematologic and end organ function
• Measurable disease per RECIST
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of atezolizumab
• ECOG: 0-1. Patients with ECOG Performance Status of 2, secondary to the underlying disease, may be enrolled after consultation with the Medical Monitor

b. Inclusion Criteria Unique to Patients Undergoing Serial Biopsy in the Serial Biopsy Dose-Expansion Cohort:
• Baseline tumor tissue samples consisting of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions will be obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 34
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 439
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 216

Exclusion Criteria

• Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
• History of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, etc.)
• History of HIV, hepatitis B, or hepatitis C infection. Patients with past or resolved Hepatitis B are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
• Any signs or symptoms of infection
• Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., CLL Rai Stage 0, prostate cancer with Gleason score = 6, and PSA = 10 mg/mL, etc.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified