Atezolizumab
DrugAtezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion.
Other names: Tecentriq
NCT Number: NCT02650713
This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion.
Other names: Tecentriq
RO6958688 is administered by IV infusion
In Part IA: RO6958688 is administered weekly (QW) on days 1,8 and 15 of each 21-day cycle.
In Part 1b: RO6958688 is administered weekly (QW) or every 3 weeks (Q3W). Cohort A: RO6958688 starting dose will be 100 mg either QW or Q3W.
Step Up dose cohorts: RO6958688 starting dose will be 40mg and increase with each administration up to the MTD or 1200 mg whichever is lower.
Time frame: Baseline up to 60 months
Time frame: Day 1 up to Day 21
Time frame: Part IA: Day 1 up to Day 21; Part IB Step-up Cohorts: Day 1 up to Day 7 after each dose escalation
Time frame: Day 1 up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Baseline up to 60 months
Time frame: Pre-infusion (1 hour before infusion start) on Day 1 of Cycles 1, 2, 3, 6; Cycle 1 Days 2 and 8 (cycle length=21 days)
Time frame: Baseline up to 60 months
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: Baseline up to 60 months
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: Baseline up to 60 months
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: From initial objective response (PR or CR to the first disease progression or death from any cause (up to 60 months)
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: From first study treatment to the first occurrence of objective disease progression or death from any cause (up to 60 months)
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: From first study treatment to death from any cause (up to 60 months)
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Time frame: Baseline up to 60 months
Assessed at screening and after the start of treatment every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or treatment discontinuation.
Hoffmann-La Roche
Industry
An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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