A Phase 1 interventional study of Atezolizumab and RO6958688 in Solid Tumors, sponsored by Hoffmann-La Roche. Completed at 24 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 228 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria
Participants will receive RO6958688 weekly (QW) at escalating doses starting at 5 mg, in combination with a fixed dose (1200 mg) of atezolizumab every 3 weeks (Q3W). RO6958688 dosage will not exceed the MTD if defined in the BP29541 study.
Drug: Atezolizumab · Drug: RO6958688
Part IB will explore different RO6958688 administration schedules in combination with atezolizumab, consisting of: Cohort A: will compare the QW vs Q3W dosing schedules at a flat dose of RO6958688. Step Up dosing schedules: RO6958688 dose will start at 40 mg and increase with each administration up to the MTD or 1200 mg, whichever occurs first.
Drug: Atezolizumab · Drug: RO6958688
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion.
Also known as: 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.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline up to 60 months
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 21
Maximum-Tolerated Dose (MTD) of RO6958688
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
Recommended Phase II Dose (RP2D) of RO6958688
Time frame: Day 1 up to 60 months
Pharmacokinetic (PK): Area Under the Concentration-Time Curve (AUC) of RO6958688
Time frame: Baseline up to 60 months
PK: Volume of Distribution at Steady State (Vss) of RO6958688
Time frame: Baseline up to 60 months
PK: Maximum Serum Concentration (Cmax) of RO6958688
Time frame: Baseline up to 60 months
PK: Clearance (CL) of RO6958688
Time frame: Baseline up to 60 months
PK: AUC of Atezolizumab
Time frame: Baseline up to 60 months
PK: Vss of Atezolizumab
Time frame: Baseline up to 60 months
PK: Cmax of Atezolizumab
Time frame: Baseline up to 60 months
PK: CL of Atezolizumab
Time frame: Baseline up to 60 months
Pharmacodynamics: Immune Cell Numbers as Assessed using Flow Cytometry
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)
Percentage of Participants with Objective Response (Partial Response [PR] or Complete Response [CR] as Assessed Using Response Evaluation Criteria in Solid Tumors [RECIST])
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
Percentage of Participants with Disease Control (PR, CR, or Stable Disease [SD]) as Assessed Using RECIST
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
Percentage of Participants with Stable Disease (SD) as Assessed Using RECIST
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
Duration of Response (DOR) as Assessed Using RECIST
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)
Progression-Free Survival (PFS) according to RECIST V1.1
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)
Overall Survival (OS)
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)
Best Overall Response (BOR)
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
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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