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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519865-23-00 | Other Identifier | EU CT Number |
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| Name | Class |
|---|---|
| Arcus Biosciences, Inc. | INDUSTRY |
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This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary purpose of this study is to determine the recommended Phase III dose (RP3D) of volrustomig and measure the efficacy and safety of volrustomig in combination with casdatifan compared with nivolumab plus ipilimumab in participants with advanced ccRCC (as 1L treatment).
The study comprises of 2 parts -
In Phase 1b part of the study, participants will be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
In Phase III part of the study, participants will be randomized in 1:1:1 to receive either Volrustomig (at the dose to be determined in the Phase Ib) in combination with casdatifan, volrustomig monotherapy or standard of care (nivolumab plus ipilimumab).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1A (Volrustomig Dose 1 + Casdatifan) | Experimental | Participants will receive dose 1 of volrustomig in combination with casdatifan. |
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| Arm 1B (Volrustomig Dose 2 + Casdatifan) | Experimental | Participants will receive dose 2 of volrustomig in combination with casdatifan. |
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| Arm 3A (Volrustomig Dose X + Casdatifan) | Experimental | Participants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan. |
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| Arm 3B (Volrustomig Dose 1) | Experimental | Participants will receive dose 1 of volrustomig. |
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| Arm 3C (Nivolumab + Ipilimumab) | Active Comparator | Participants will receive nivolumab plus ipilimumab as standard of care treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volrustomig | Drug | Volrustomig will be administered as an intravenous (IV) infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Number of participants who received at least one dose of study treatment will be assessed. | Approximately 39 months |
| Phase III: Progression-free Survival (PFS) | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 38 months |
| Phase III: Overall Survival (OS) | The OS is defined as the time from randomization until the date of death due to any cause. | Approximately 67 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Objective Response rate (ORR) | The ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR). | Approximately 39 months |
| Phase Ib: Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | 92037 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Casdatifan | Drug | Casdatifan will be administered orally. |
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| Nivolumab | Drug | Nivolumab will be administered as an IV infusion. |
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| Ipilimumab | Drug | Ipilimumab will be administered as an IV infusion. |
|
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The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death due to any cause.
| Approximately 39 months |
| Phase Ib: Progression-free Survival (PFS) | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 39 months |
| Phase Ib: Disease Control Rate (DCR) | The DCR is defined as the percentage of participants who have a confirmed CR or PR or who have stable disease (SD) after randomization. | Approximately 39 months |
| Phase Ib: Volrustomig concentration in serum | To assess the serum concentration of volrustomig when administered concomitantly with casdatifan. | Up to 27 months |
| Phase Ib: Casdatifan concentration in plasma | To assess the plasma concentration of casdatifan when administered concomitantly with volrustomig. | Up to 27 months |
| Phase Ib: Time to Response (TTR) | The TTR is defined as the time from randomization until the first documentation of a subsequently confirmed objective response. | Approximately 39 months |
| Phase III: Overall Survival | The OS is defined as the time from randomization until the date of death due to any cause. | Approximately 67 months |
| Phase III: Number of participants with AEs and SAEs | Number of participants who received at least one dose of study treatment will be assessed. | Approximately 67 months |
| Phase III: Time to second progression or death (PFS2) | The PFS2 is defined as the time from randomization to the earliest progression event after the start of the first subsequent therapy, or death from any cause, whichever occurs first. | Approximately 67 months |
| Phase III: Objective Response rate (ORR) | The ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR. | Approximately 67 months |
| Phase III: Duration of Response (DoR) | The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death due to any cause. | Approximately 67 months |
| Phase III: Progression-free Survival | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 67 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Lubbock | Texas | 79430 | United States |
| Research Site | East Melbourne | 3002 | Australia |
| Research Site | Elizabeth Vale | 5112 | Australia |
| Research Site | North Adelaide | 5000 | Australia |
| Research Site | Syndey | 4032 | Australia |
| Research Site | Beijing | 100142 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Nanjing | 2100008 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Xiamen | 361003 | China |
| Research Site | Batumi | 6010 | Georgia |
| Research Site | Tbilisi | 0112 | Georgia |
| Research Site | Tbilisi | 0114 | Georgia |
| Research Site | Tbilisi | 0186 | Georgia |
| Research Site | Busan | 48108 | South Korea |
| Research Site | Seongnam-si | 13496 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 5505 | South Korea |
| Research Site | Kaohsiung City | 833401 | Taiwan |
| Research Site | Taichung | 404327 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| ID | Term |
|---|---|
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| 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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