2024-517785-42-00CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination with Cabozantinib Versus Cabozantinib Alone in Patients with Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination with Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Nov 2024
Brief summary (registry, in English)
To evaluate the efficacy of atezolizumab in combination with cabozantinib (i.e. atezolizumab + cabozantinib arm) compared with cabozantinib alone (cabozantinib arm) in the intent-to-treat population
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 26 Sept 2024
- Start date
- 8 Oct 2020
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Kidney cancer
- EU CT number
- 2024-517785-42-00
- EudraCT number
- 2020-000502-29
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 64
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
- Patients who received cabozantinib at any time prior to screening
- Patients who received more than one ICI treatment in the locally advanced or metastatic setting
- Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
- Patients who have received a mammalian target of rapamycin inhibitor in any setting
Other
- Symptomatic, untreated, or actively progressing CNS metastases
Who the study is looking for
- Histologically confirmed locally advanced or metastatic clear cell or non-clear cell RCC (papillary, chromophobe and unclassified only). RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
- Evaluable International Metastatic Renal Cell Carcinoma Database Consortium risk scores
- Radiographic disease progression to prior immune checkpoint inhibitor (ICI) therapy for RCC
- Karnofsky Performance Status score of >= 70
- Adequate hematologic and end-organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum rechts der Isar der TU Muenchen AöR | Munich | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Completed |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Completed |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy | Bydgoszcz | Poland | Completed |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. | Otwock | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Completed |
| Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. | Warsaw | Poland | Completed |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Poland | Completed |
Are you the coordinator? Confirm the details
In 2 countries, 8 sites
Poland 5, Germany 3
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.