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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006032-92 | EudraCT Number |
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Slow recruitment
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This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).
In the Phase Ia part of the study, tiragolumab is administered as a single agent in participants with R/R MM or R/R NHL.
In the Phase Ib part of the study, tiragolumab is administered in combination with atezolizumab and/or daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Tiragolumab R/R MM | Experimental | Participants with relapsed or refractory (R/R) Multiple Myeloma (MM) will receive a single dose of 600 mg tiragolumab by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). |
|
| Arm B: Tiragolumab R/R NHL | Experimental | Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg tiragolumab by IV infusion Q3W. |
|
| Arm C: Tiragolumab + Daratumumab R/R MM | Experimental | Participants with R/R MM will receive 600 mg tiragolumab Q3W + daratumumab by subcutaneous (SC) injection. |
|
| Arm D: Tiragolumab + Rituximab R/R NHL | Experimental | Participants with R/R NHL will receive 600 mg tiragolumab Q3W + rituximab by IV infusion and SC injection (optional). |
|
| Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM | Experimental | Participants with R/R MM will receive 600 mg tiragolumab Q3W + atezolizumab by IV infusion Q3W + daratumumab by SC injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiragolumab | Drug | Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Determined according to the NCI CTCAE Version 5.0 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Tiragolumab | Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) | |
| Serum Concentration of Atezolizumab | Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) |
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Inclusion Criteria:
General Inclusion Criteria (All Participants):
Inclusion Criteria Specific to Arms A, C and E (R/R MM):
Inclusion Criteria Specific to Arms B and D (R/R NHL):
Exclusion Criteria:
General Exclusion Criteria (All Participants):
Exclusion Criteria Specific to Arms A, C and E (R/R MM):
Exclusion Criteria Specific to Arms B and D (R/R NHL):
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center | Denver | Colorado | 80218 | United States | ||
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| Daratumumab/rHuPH20 | Drug | Administered by SC injection 1800 mg/30,000 U rHuPH20 weekly for a total of 6 doses, then every 3 weeks for a total of 16 doses (first dose given at Week 7), then every 4 weeks from Week 55 onward until disease progression |
|
| Rituximab | Drug | Administered for a total of 8 doses. Rituximab will be administered by IV infusion for the first dose at a dose of 375 mg/m^2. After administration of at least one full infusion of IV rituximab, the SC formulation of rituximab (rituximab and rHuPH20) may be used for the remaining doses per institutional guidelines. SC rituximab will be administered at a dose of 1400 mg rituximab/23400 U rHuPH20 once weekly (QW). |
|
| Atezolizumab | Drug | Administered by IV infusion at a fixed dose of 1200 mg Q3W |
|
| Objective Response Rate (ORR) for R/R MM | Proportion of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), as defined by the International Myeloma Working Group (IMWG) criteria | Through study completion, an average of 1 year |
| ORR for R/R NHL | Proportion of participants with a CR or PR on two consecutive occasions >/= 4 weeks apart, according to the Lugano classification | Through study completion, an average of 1 year |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) |
| Percentage of Participants With ADAs to Atezolizumab | Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) |
| Emory Clinic |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Washington University | St Louis | Missouri | 63128 | United States |
| Clinical Research Alliance | Westbury | New York | 11590 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45236 | United States |
| University of Pennsylvania; School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI | Nashville | Tennessee | 37203 | United States |
| Virginia Cancer Specialists (Fairfax) - USOR | Fairfax | Virginia | 22031 | United States |
| Samsung Medical Center; Nephrology Department | Seoul | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Yonsei Cancer Center; Yonsei Uni Coll. Med. | Seoul | 120-752 | South Korea |
| Seoul St.Mary's Hospital; Medical Oncology | Seoul | 137-807 | South Korea |
| Asan Medical Center; Internal Dept / Gastorenterology | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000730814 | Tiragolumab |
| C556306 | daratumumab |
| D000069283 | Rituximab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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