Informations générales (source: ClinicalTrials.gov)
A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy
Interventional
Phase 2
Hoffmann-La Roche (Voir sur ClinicalTrials)
avril 2023
décembre 2026
05 août 2025
This study will evaluate the safety of tobemstomig alone or in combination with
tiragolumab compared with atezolizumab in participants with previously untreated, locally
advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum
containing chemotherapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 13/05/2024 10:01:21 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon CEDEX 08 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Histologically or cytologically documented locally advanced or metastatic
transitional cell carcinoma (TCC) of the urothelium. Participants with squamous,
sarcomatoid, micropapillary, and glandular variant histologies are eligible for
inclusion in the study, provided that a urothelial component is present in the tumor
specimen. Participants with other variant histologies or pure variant histologies
are not eligible for inclusion in this study
- Ineligible ("unfit") to receive platinum-based chemotherapy
- No prior chemotherapy for inoperable locally advanced or metastatic or recurrent
urothelial carcinoma (UC)
- Measurable disease; at least one measurable lesion as defined by response evaluation
criteria in solid tumors, version 1.1 (RECIST v1.1)
- Availability of a representative leftover tumor specimen that is suitable for
determination of PD-L1 status as assessed by a central laboratory
- Adequate hematologic and end organ function
- Negative for hepatitis B and hepatitis C virus (HCV)
- Adequate cardiovascular function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Histologically or cytologically documented locally advanced or metastatic
transitional cell carcinoma (TCC) of the urothelium. Participants with squamous,
sarcomatoid, micropapillary, and glandular variant histologies are eligible for
inclusion in the study, provided that a urothelial component is present in the tumor
specimen. Participants with other variant histologies or pure variant histologies
are not eligible for inclusion in this study
- Ineligible ("unfit") to receive platinum-based chemotherapy
- No prior chemotherapy for inoperable locally advanced or metastatic or recurrent
urothelial carcinoma (UC)
- Measurable disease; at least one measurable lesion as defined by response evaluation
criteria in solid tumors, version 1.1 (RECIST v1.1)
- Availability of a representative leftover tumor specimen that is suitable for
determination of PD-L1 status as assessed by a central laboratory
- Adequate hematologic and end organ function
- Negative for hepatitis B and hepatitis C virus (HCV)
- Adequate cardiovascular function
- Pregnancy or breastfeeding
- GFR <15 mL/min/1.73 m2
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on
screening chest computed tomography (CT) scan
- Active tuberculosis (TB) or acute Epstein-Barr virus (EBV)
- Significant cardiovascular/cerebrovascular disease within 3 months prior to
initiation of study treatment
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to
initiation of study treatment, or anticipation of need for a major surgical
procedure during the study
- History of another primary malignancy other than urothelial carcinoma within 2 years
prior to initiation of study treatment, with the exception of malignancies with a
negligible risk of metastasis or death
- Severe infection within 4 weeks prior to initiation of study treatment
- Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to
initiation of study treatment. Participants receiving prophylactic antibiotics
(e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease
[COPD] exacerbation), or who are receiving oral antibiotics to treat a urinary tract
infection are eligible for the study
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of
study treatment, or anticipation of need for such a vaccine during treatment or
within 5 months after the final dose of atezolizumab, 4 months after the final dose
of tobemstomig, or 90 days after the final dose of tiragolumab
- Current treatment with anti-viral therapy for HBV
- Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal
therapy, within 3 weeks prior to initiation of study treatment
- Treatment with investigational therapy within 4 weeks or 5 drug-elimination
half-lives (whichever is longer) prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting
agents
- Treatment with systemic immunostimulatory agents within 4 weeks or 5
drug-elimination half-lives prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of need for systemic
immunosuppressive medication during study treatment
- History of severe allergic anaphylactic reactions to chimeric or humanized
antibodies or fusion proteins