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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000516-18 | EudraCT Number |
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This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: MOXR0916 + Atezolizumab | Experimental | Cohorts of at least 3 participants each will be treated at escalating doses of MOXR0916 in combination with a fixed dose of atezolizumab to determine the MTD or maximum administered dose (MAD). |
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| Expansion: MOXR0916 + Atezolizumab | Experimental | Approximately 250-580 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, pharmacokinetic variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + atezolizumab in different cancer types. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody | Drug | Atezolizumab will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities (DLTs) | Days (D) 1-21 of Cycle (C) 1 (cycle = 21 days); up to D42 if extended monitoring warranted | |
| Number of Participants with Adverse Events Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 | Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of MOXR0916 | Up to 1 year | |
| Recommended Phase II Dose (RP2D) of MOXR0916 | Up to 1 year | |
| Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Bisgrove | Scottsdale | Arizona | 85258 | United States | ||
| University of Colorado |
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| MOXR0916, a humanized agonist anti-OX40 monoclonal antibody | Drug | MOXR0916 will be administered intravenously. |
|
| Up to 120 days after the treatment discontinuation visit |
| Number of Cycles Received with MOXR0916 | Baseline until treatment discontinuation (up to 3 years) |
| Dose Intensity of MOXR0916 | Baseline until treatment discontinuation (up to 3 years) |
| Area under the Concentration-Time Curve (AUC) of MOXR0916 | Up to 120 days after the treatment discontinuation visit |
| Serum Maximum Observed Concentration (Cmax) of MOXR0916 | Up to 120 days after the treatment discontinuation visit |
| Serum Minimum Observed Concentration (Cmin) of MOXR0916 | Up to 120 days after the treatment discontinuation visit |
| Clearance (CL) of MOXR0916 | Up to 120 days after the treatment discontinuation visit |
| Volume of Distribution at Steady State (Vss) of MOXR0916 | Up to 120 days after the treatment discontinuation visit |
| Serum Cmax of Atezolizumab | Up to 120 days after the treatment discontinuation visit |
| Serum Cmin of Atezolizumab | Up to 120 days after the treatment discontinuation visit |
| Percentage of Participants with Objective Response Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Baseline until disease progression (up to 3 years) |
| Duration of Objective Response (DOR) Determined Using RECIST v1.1 | From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years) |
| Progression-Free Survival (PFS) Determined Using RECIST v1.1 | Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years) |
| Percentage of Participants with Objective Response Determined Using Modified RECIST | Baseline until disease progression (up to 3 years) |
| DOR Determined Using Modified RECIST | From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years) |
| PFS Determined Using Modified RECIST | Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years) |
| Overall Survival (OS) | Baseline until death (up to 3 years) |
| Aurora |
| Colorado |
| 80045-2517 |
| United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| University Of Chicago Medical Center; Section Of Hematology/Oncology | Chicago | Illinois | 60637 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Gustave Roussy | Villejuif | 94800 | France |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Yonsei University Health System/Severance Hospital | Seoul | 120-752 | South Korea |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000906 | Antibodies |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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