Clinical trial • Phase II • Oncology

RO7247669 (TOBEMSTOMIG) for Urothelial carcinoma (locally advanced or metastatic)

Phase II trial of RO7247669 (TOBEMSTOMIG) for Urothelial carcinoma (locally advanced or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Urothelial carcinoma (locally advanced or metastatic)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Other antibody

Key dates

Initial CTIS Submission Date
17-04-2024
First CTIS Authorization Date
30-05-2024

Trial design

Randomised, open-label, arm a: atezolizumab (tecentriq) — comparator/control; product listed as "tecentriq 1 200 mg concentrate for solution for infusion" (active substance: atezolizumab). arm b: tobemstomig (ro7247669) — experimental (product ro7247669). arm c: tobemstomig (ro7247669) + tiragolumab — experimental combination (products ro7247669 and tiragolumab). specific dosing schedules are not detailed in the provided record. Phase II trial across 30 sites in Denmark, Germany, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Atezolizumab (Tecentriq) — comparator/control; product listed as "Tecentriq 1 200 mg concentrate for solution for infusion" (active substance: atezolizumab). Arm B: Tobemstomig (RO7247669) — experimental (product RO7247669). Arm C: Tobemstomig (RO7247669) + Tiragolumab — experimental combination (products RO7247669 and Tiragolumab). Specific dosing schedules are not detailed in the provided record.
Biomarker Stratified
True, PD-L1 status (stratified by central laboratory)
Target Sample Size
94

Stratification factors

  • PD-L1 status (stratification assessed by a central laboratory)

Eligibility

Recruits 94 Vulnerable population selection is indicated (isVulnerablePopulationSelected = true). Subject information and informed consent documents include specific forms such as "L1_ICF_Infant Authorization", "L1_SIS andICF_new born child", partner and pregnancy-specific ICFs and multiple language versions. Informed consent is obtained using these ICFs; specific authorization forms for infants/newborns and partner-related documents are provided. Details on assent procedures are not specified in the available record..

Pregnancy Exclusion
1. Pregnancy or breastfeeding, or intention of becoming pregnant during study 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
Vulnerable Population
Vulnerable population selection is indicated (isVulnerablePopulationSelected = true). Subject information and informed consent documents include specific forms such as "L1_ICF_Infant Authorization", "L1_SIS andICF_new born child", partner and pregnancy-specific ICFs and multiple language versions. Informed consent is obtained using these ICFs; specific authorization forms for infants/newborns and partner-related documents are provided. Details on assent procedures are not specified in the available record.

Inclusion criteria

  • {"criterion_text":"- 1. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n- 2. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Patients 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. Patients with other variant histologies or pure variant histologies are not eligible for inclusion in the study\n- 3. Considered to be ineligible (\"unfit\") to receive platinum-based chemotherapy defined by one of the following criteria: • ECOG Performance Status of 0 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 30 mL/min/1.73 m2 • ECOG Performance Status of 1 or 2 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 45 mL/min/1.73 m2 • ECOG Performance Status of 0-2 with Grade ≥ 2 neuropathy • Patients for whom chemotherapy is not deemed appropriate\n- 4. No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)\n- 5. Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)\n- 6. Availability of a representative leftover tumor specimen that meet the criteria outlined prior to study enrollment, and that is suitable for determination of programmed death-ligand 1 (PD-L1) status, and for stratification as assessed by a central laboratory"}

Exclusion criteria

  • {"criterion_text":"- 1. Pregnancy or breastfeeding, or intention of becoming pregnant during study 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\n- 2. Glomerular filtration rate (GFR) < 15 mL/min/1.73 m2 as calculated through use of the chronic kidney disease epidemiology collaboration (CKD-EPI) equation or receiving dialysis\n- 3. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n- 4. History of leptomeningeal disease\n- 5. Uncontrolled tumor-related pain. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures and uncontrolled or symptomatic hypercalcemia\n- 6. 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 or chronic active Epstein-Barr virus (EBV)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5), with the exception of Cytokine Release Syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT)","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v5; severity of Cytokine Release Syndrome (CRS) determined according to ASTCT criteria."}

Recruitment

Planned Sample Size
94
Recruitment Window Months
43
Consent Approach
Informed consent is obtained using subject information and informed consent forms (ICFs). Multiple ICF documents exist (including main ICFs, partner/pregnancy ICFs, infant/newborn authorization forms and optional biopsy ICFs). ICFs and patient-facing documents are available in multiple languages (examples in the record include English, German, Spanish, French, Italian, Greek, Polish). Specific details on who provides consent for infants/newborns are addressed via dedicated infant/newborn authorization documents; explicit assent procedures are not detailed in the available record.

Geography

Total Number Of Sites
30
Total Number Of Participants
150

Denmark

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
803
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Aarhus Universitetshospital
Department Name
Kræftafdelingen
Principal Investigator Name
Mette Marie Fode
Principal Investigator Email
mettfode@rm.dk
Contact Person Name
Mette Marie Fode
Contact Person Email
mettfode@rm.dk
Site Name
Region Hovedstaden
Department Name
Afdeling for Kræftbehandling, Herlev Hospital
Principal Investigator Name
Line Hammer Dohn
Principal Investigator Email
Line.hammer.dohn.02@regionh.dk
Contact Person Name
Line Hammer Dohn
Contact Person Email
Line.hammer.dohn.02@regionh.dk
Site Name
Odense University Hospital
Department Name
Onkologisk Afdeling R
Principal Investigator Name
Niels Viggo Jensen
Principal Investigator Email
niels.viggo.jensen@rsyd.dk
Contact Person Name
Niels Viggo Jensen
Contact Person Email
niels.viggo.jensen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Klinisk forskningsenhed, Onkologisk Afdeling
Principal Investigator Name
Andreas Carus
Principal Investigator Email
andreascarus@rn.dk
Contact Person Name
Andreas Carus
Contact Person Email
andreascarus@rn.dk

Germany

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
26-05-2025
Processing Time Days
831
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie
Principal Investigator Name
Gunhild von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Uroonkologisches Zentrum
Principal Investigator Name
Günter Niegisch
Principal Investigator Email
Guenter.Niegisch@med.uni-duesseldorf.de
Contact Person Name
Günter Niegisch
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Urologie
Principal Investigator Name
Florian Seseke
Principal Investigator Email
Florian.Seseke@Martha-Maria.de
Contact Person Name
Florian Seseke
Contact Person Email
Florian.Seseke@Martha-Maria.de

Italy

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
29-04-2025
Processing Time Days
804
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncologia
Principal Investigator Name
Sergio Bracarda
Principal Investigator Email
s.bracarda@aospterni.it
Contact Person Name
Sergio Bracarda
Contact Person Email
s.bracarda@aospterni.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Unità Operativa Oncologia Medica
Principal Investigator Name
Francesco Massari
Principal Investigator Email
francesco.massari@aosp.bo.it
Contact Person Name
Francesco Massari
Contact Person Email
francesco.massari@aosp.bo.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica Seconda
Principal Investigator Name
Marco Maruzzo
Principal Investigator Email
marco.maruzzo@iov.veneto.it
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it
Site Name
University Hospital Consorziale Policlinico
Department Name
U.O. Oncologia Medica Universitaria
Principal Investigator Name
Mimma Rizzo
Principal Investigator Email
trials.rizzo@gmail.com
Contact Person Name
Mimma Rizzo
Contact Person Email
trials.rizzo@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Giampaolo Tortora
Principal Investigator Email
giampaolo.tortora@policlinicogemelli.it
Contact Person Name
Giampaolo Tortora
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dipartimento Uro-Ginecologico
Principal Investigator Name
Rosa Tambaro
Principal Investigator Email
m.tambaro@istitutotumori.na.it
Contact Person Name
Rosa Tambaro
Contact Person Email
m.tambaro@istitutotumori.na.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Emilio Francesco Giunta
Principal Investigator Email
emilio.giunta@irst.emr.it
Contact Person Name
Emilio Francesco Giunta
Contact Person Email
emilio.giunta@irst.emr.it

France

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
803
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Institut Gustave Roussy
Department Name
DITEP
Principal Investigator Name
Yohann Loriot
Principal Investigator Email
yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohann Loriot
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
oncologie
Principal Investigator Name
Florian Estrade
Principal Investigator Email
f.estrade@rennes.unicancer.fr
Contact Person Name
Florian Estrade
Contact Person Email
f.estrade@rennes.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Oncologie
Principal Investigator Name
Aude Flechon
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude Flechon
Contact Person Email
aude.flechon@lyon.unicancer.fr

Greece

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
1169
Number Of Sites
2
Number Of Participants
32

Sites

Site Name
Theageneio Cancer Hospital
Department Name
Oncology Clinic Theageneio
Principal Investigator Name
Grigorios Rallis
Principal Investigator Email
grrallis@yahoo.com
Contact Person Name
Grigorios Rallis
Contact Person Email
grrallis@yahoo.com
Site Name
Alexandra Hospital
Department Name
Clinical Therapeutics Department / Oncology Unit
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk

Poland

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
1176
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Pratia S.A.
Department Name
Pratia Poznań
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
md.piotr.tomczak@gmail.com
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Department Name
Oddział Chemioterapii
Principal Investigator Name
Iwona Skoneczna
Principal Investigator Email
iskoneczna@grochowski.waw.pl
Contact Person Name
Iwona Skoneczna
Contact Person Email
iskoneczna@grochowski.waw.pl

Spain

Earliest CTIS Part Ii Submission Date
15-02-2023
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
1168
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
David Marmolejo Castañeda
Principal Investigator Email
davidmarmolejo@vhio.net
Contact Person Name
David Marmolejo Castañeda
Contact Person Email
davidmarmolejo@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Daniel Castellano Gauna
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncología
Principal Investigator Name
Xavier Garcia del Muro
Principal Investigator Email
garciadelmuro@iconcologia.net
Contact Person Name
Xavier Garcia del Muro
Contact Person Email
garciadelmuro@iconcologia.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncología
Principal Investigator Name
Javier Puente Vázquez
Principal Investigator Email
jpuente.hcsc@salud.madrid.org
Contact Person Name
Javier Puente Vázquez
Contact Person Email
jpuente.hcsc@salud.madrid.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncología
Principal Investigator Name
Elena Sevillano Fernandez
Principal Investigator Email
esevillano@hmhospitales.com
Contact Person Name
Elena Sevillano Fernandez
Contact Person Email
esevillano@hmhospitales.com
Site Name
Hospital Universitario La Paz
Department Name
Oncología
Principal Investigator Name
Álvaro Pinto Marín
Principal Investigator Email
alvaropintomarin@gmail.com
Contact Person Name
Álvaro Pinto Marín
Contact Person Email
alvaropintomarin@gmail.com
Site Name
Hospital Universitario La Paz (additional listed site entries aggregated)
Department Name
Oncología
Principal Investigator Name
Álvaro Pinto Marín
Principal Investigator Email
alvaropintomarin@gmail.com
Contact Person Name
Álvaro Pinto Marín
Contact Person Email
alvaropintomarin@gmail.com

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Almac Clinical Technologies LLC
Name
Frontage Laboratories Inc.
Name
Icon Development Solutions LLC

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
RO7247669
Active Substance
RO7247669 (TOBEMSTOMIG)
Modality
Other antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
600 mg
Investigational Product Name
Tiragolumab
Active Substance
TIRAGOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
600 mg
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation EU/1/17/1220/001 (authorised)
Maximum Dose
1200 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.