AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF ATEZOLIZUMAB IN ADVANCED SOLID TUMORS

Phase 2

Completed

• Conditions: gevorderde solide tumoren; Advanced solid tumors; cancer

• Registration Number: NL-OMON47718
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1.Histologically documented advanced (i.e. stages III or IV) solid timors that
meet protocol defined cohort specifications, with progressive disease at study
entry and at least one line of prior line systemic anticancer therapy or for
which there is no alternative therapy known to prolong survival , Measurable
disease as defined by RECIST, v1.1. (except for prostate cancer and malignant
pleural mesothelioma) and disease-specific criteria for patients with prostate
cancer (see Appendix 6) and malignant pleural mesothelioma (see Appendix 7), 3.
Estern Cooperative Oncology group (ECOG) Performance Status of 0 or 1, 4.
Adequate hematologic and end organ function, defined by labortory results
obtained within 3 days prior to the first study treatment., 5.Women who are not
postmenopausal (* 12 months of non-therapy-induced amenorrhea) or surgically
sterile must have a negative serum pregnancy test result within 14 days prior
to initiation of study drug

Exclusion Criteria

1. 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 treated with expected curative outcome, 2 .History of treated
asymptomatic or symptomatic CNS metastasis or presence of CNS metastases as
determined by CT or MRI evaluation during screening and prior radiographic
assessments, 3 .Leptomeningeal disease, 4. Any approved anticancer therapy,
including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior
to initiation of study treatment; with certain exception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy objective for this study is as follows:<br /><br>1. To evaluate non-progression rate (NPR) at 18 weeks in patients with advanced<br /><br>solid tumors treated with Atezolizumab, defined as the<br /><br>percentage of patients with complete response (CR) partial response (PR) or<br /><br>stable disease (SD) as assessed by the Investigator according to<br /><br>Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) or<br /><br>according to disease specific criteriat for prostate cancer and malignant<br /><br>pleural mesothelioma</p><br>