A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Key facts
- Where
- Barcelona, Córdoba, Madrid, Sevilla és Valencia, SpanyolországSee the 8 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital General Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Ramón y CajalMadrid, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-505816-39-00
- Record updated
- 2026. augusztus 24.
- Original description
To evaluate the safety and tolerability of Arm A (tobemstomig + axitinib) vs. Control Arm (pembrolizumab + axitinib) and Arm B (Tiragolumab + tobemstomig + axitinib) vs. Control Arm in the safety evaluable (SE) populationRead full original descriptionShow less
A Randomized, Open-Label, Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
To evaluate the safety and tolerability of Arm A (tobemstomig + axitinib) vs. Control Arm (pembrolizumab + axitinib) and Arm B (Tiragolumab + tobemstomig + axitinib) vs. Control Arm in the safety evaluable (SE) population
Inclusion: International Metastatic Renal Cell Carcinoma Database Consortium IMDC risk intermediate (score of 1 or 2), or poor (score of 3 to 6); Measurable disease, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Adequate hematologic and end-organ function (within 14 days prior to study treatment); Histologically confirmed clear-cell renal cell carcinoma renal cell carcinoma (ccRCC) with or without sarcomatoid features; non-clear-cell renal cell carcinoma (nccRCC) subtypes (papillary, chromophobe, and unclassified) are not allowed; Negative hepatitis B surface antigen (HBsAg) test and hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening; Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening.
Exclusion: Prior treatment for localized and/or metastatic RCC with systemic RCC directed therapy; Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer; Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment; History of leptomeningeal disease; Moderate to severe hepatic impairment (Child-Pugh B or C); Symptomatic, untreated, or actively progressing CNS metastases.