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| ID | Type | Description | Link |
|---|---|---|---|
| RG7802 | Other Identifier | Roche | |
| 2015-003771-30 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation (Part IA): RO6958688 + Atezolizumab | Experimental | 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. |
|
| Dose/Schedule Finding (Part IB): RO6958688 + Atezolizumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Baseline up to 60 months | |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | Day 1 up to Day 21 | |
| Maximum-Tolerated Dose (MTD) of RO6958688 | 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 | Day 1 up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): Area Under the Concentration-Time Curve (AUC) of RO6958688 | Baseline up to 60 months | |
| PK: Volume of Distribution at Steady State (Vss) of RO6958688 | Baseline up to 60 months |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Cancer Center | Santa Monica | California | 90404 | United States | ||
| Stanford Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36261015 | Derived | Martinez-Sabadell A, Morancho B, Rius Ruiz I, Roman Alonso M, Ovejero Romero P, Escorihuela M, Chicote I, Palmer HG, Nonell L, Alemany-Chavarria M, Klein C, Bacac M, Arribas J, Arenas EJ. The target antigen determines the mechanism of acquired resistance to T cell-based therapies. Cell Rep. 2022 Oct 18;41(3):111430. doi: 10.1016/j.celrep.2022.111430. |
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| RO6958688 | Drug | 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. |
|
| PK: Maximum Serum Concentration (Cmax) of RO6958688 | Baseline up to 60 months |
| PK: Clearance (CL) of RO6958688 | Baseline up to 60 months |
| PK: AUC of Atezolizumab | Baseline up to 60 months |
| PK: Vss of Atezolizumab | Baseline up to 60 months |
| PK: Cmax of Atezolizumab | Baseline up to 60 months |
| PK: CL of Atezolizumab | Baseline up to 60 months |
| Pharmacodynamics: Immune Cell Numbers as Assessed using Flow Cytometry | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline up to 60 months |
| Stanford |
| California |
| 94305 |
| United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Smilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug Pharmacy | New Haven | Connecticut | 06510 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Columbia Univ Med Ctr | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sarah Cannon Cancer Center | Germantown | Tennessee | 38138 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Rigshospitalet; Onkologisk Klinik | København Ø | 2100 | Denmark |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Tuscany | 53100 | Italy |
| Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie | Amsterdam | 1066 CX | Netherlands |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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