JOURNAL ONKOLOGIE – STUDIE

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05645692

Studienbeginn:
April 2023

Letztes Update:
16.04.2024

Wirkstoff:
Atezolizumab, Tobemstomig, Tiragolumab

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-LaRoche

Kontakt

Reference Study ID Number: BO44157 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 80)

Universitätsklinikum Düsseldorf; Urologische Klinik
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps

Martini-Klinik am UKE GmbH
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Muenster; Urology
48149 Muenster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Universitätsklinikum Tübingen; Klinik für Urologie
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Advent Health Orlando
32804 Orlando
United StatesRekrutierend» Google-Maps

Cleveland Clinic
44106 Cleveland
United StatesRekrutierend» Google-Maps

SCRI Mark H. Zangmeister Center
43219 Columbus
United StatesRekrutierend» Google-Maps

Sarah Cannon Research Institute / Tennessee Oncology
37404 Chattanooga
United StatesRekrutierend» Google-Maps

SCRI Oncology Partners
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps

MD Anderson Cancer Center; Oncology
77030 Houston
United StatesRekrutierend» Google-Maps

Fred Hutchinson Cancer Research Center
98109 Seattle
United StatesRekrutierend» Google-Maps

Macquarie University Hospital
2109 Macquarie Park
AustraliaRekrutierend» Google-Maps

Lyell McEwin Hospital
5112 Adelaide
AustraliaRekrutierend» Google-Maps

ICON Cancer Care Adelaide
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps

Hospital Universitario Evangelico De Curitiba
80440-220 Curitiba
BrazilRekrutierend» Google-Maps

Oncoclinicas Rio de Janeiro S.A.
22250-905 Rio de Janeiro
BrazilRekrutierend» Google-Maps

Hospital de Amor Amazônia
76834-899 Porto Velho
BrazilRekrutierend» Google-Maps

Hospital das Clinicas - UFRGS
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps

*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
09060-650 Santo André
BrazilRekrutierend» Google-Maps

Hospital Alemao Oswaldo Cruz
01323-903 Sao Paulo
BrazilRekrutierend» Google-Maps

Peking University First Hospital
100034 Beijing City
ChinaRekrutierend» Google-Maps

Beijing Cancer Hospital
100142 Beijing
ChinaRekrutierend» Google-Maps

West China Hospital - Sichuan University
610047 Chengdu City
ChinaAktiv, nicht rekrutierend» Google-Maps

Sun yat-sen University Cancer Center; Internal Medicine of Oncology
510060 Guangzhou
ChinaRekrutierend» Google-Maps

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
200025 Shanghai City
ChinaRekrutierend» Google-Maps

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
200127 Shanghai
ChinaZurückgezogen» Google-Maps

Tianjin Cancer Hospital; urologic tumor
300060 Tianjin City
ChinaRekrutierend» Google-Maps

Union Hospital Tongji Medical College Huazhong University of Science and Technology
430023 Wuhan City
ChinaRekrutierend» Google-Maps

Aalborg Universitetshospital; Onkologisk Afdeling
9000 Aalborg
DenmarkRekrutierend» Google-Maps

Aarhus Universitetshospital; Kræftafdelingen
8200 Aarhus N
DenmarkRekrutierend» Google-Maps

Herlev Hospital; Afdeling for Kræftbehandling
2730 Herlev
DenmarkRekrutierend» Google-Maps

Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
5000 Odense C
DenmarkRekrutierend» Google-Maps

CHRU Besançon
25030 Besançon
FranceRekrutierend» Google-Maps

CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
33075 Bordeaux
FranceRekrutierend» Google-Maps

Centre Leon Berard
69373 Lyon CEDEX 08
FranceRekrutierend» Google-Maps

Institut Régional du Cancer de Montpellier
34298 Montpellier
FranceRekrutierend» Google-Maps

Centre Eugène Marquis
35000 Rennes
FranceRekrutierend» Google-Maps

Gustave Roussy
94805 Villejuif
FranceRekrutierend» Google-Maps

Alexandras General Hospital of Athens; Oncology Department
115 28 Athens
GreeceRekrutierend» Google-Maps

Athens Medical Center; Dept. of Oncology
151 25 Athens
GreeceRekrutierend» Google-Maps

Attikon University General Hospital
124 62 Chaidari
GreeceRekrutierend» Google-Maps

Theageneio Hospital
546 39 Thessaloniki
GreeceRekrutierend» Google-Maps

ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
40138 Bologna
ItalyAktiv, nicht rekrutierend» Google-Maps

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyRekrutierend» Google-Maps

Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
00168 Roma
ItalyRekrutierend» Google-Maps

Irccs Ospedale San Raffaele
20132 Milano
ItalyRekrutierend» Google-Maps

A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria
70124 Bari
ItalyRekrutierend» Google-Maps

Azienda Ospedaliera S. Maria - Terni; Oncologia
05100 Terni
ItalyRekrutierend» Google-Maps

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
35128 Padova
ItalyRekrutierend» Google-Maps

Seoul National University Bundang Hospital; Internal Medicine
Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps

Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Severance Hospital, Yonsei University
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Health Pharma Professional Research
03100 Cdmx
MexicoRekrutierend» Google-Maps

Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia
06720 Mexico City
MexicoRekrutierend» Google-Maps

Instituto Nacional de Cancerologia
14080 Mexico City
MexicoRekrutierend» Google-Maps

Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
75-581 Koszalin
PolandRekrutierend» Google-Maps

Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
31-501 Kraków
PolandRekrutierend» Google-Maps

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
10-228 Olsztyn
PolandRekrutierend» Google-Maps

Centrum Medyczne Pratia Poznan
60-185 Skórzewo
PolandRekrutierend» Google-Maps

Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
04-073 Warszawa
PolandRekrutierend» Google-Maps

Hospital Univ Vall d'Hebron; Servicio de Oncologia
08740 Sant Andreu de La Barca
SpainRekrutierend» Google-Maps

Institut Catala d Oncologia Hospital Duran i Reynals
08908 Barcelona
SpainRekrutierend» Google-Maps

Hospital Universitario Clínico San Carlos; Servicio de Oncologia
28040 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainRekrutierend» Google-Maps

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
28050 Madrid
SpainRekrutierend» Google-Maps

Adana Baskent University Medical Faculty; Oncology
01220 Adana
TurkeyRekrutierend» Google-Maps

Ankara City Hospital; Oncology
06800 Ankara
TurkeyRekrutierend» Google-Maps

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
22030 Edirne
TurkeyAktiv, nicht rekrutierend» Google-Maps

Izmir Medical Point Hospital
35101 Izmir
TurkeyRekrutierend» Google-Maps

Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
34722 Kadiköy
TurkeyRekrutierend» Google-Maps

Western General Hospital; Clinical Oncology
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps

Barts and the London NHS Trust
E1 2ES London
United KingdomRekrutierend» Google-Maps

Royal Preston Hosptial
PR2 9HT Preston
United KingdomRekrutierend» Google-Maps

Royal Marsden Hospital (Sutton)
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

This study will evaluate the efficacy, safety, and pharmacokinetics 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.

Ein-/Ausschlusskriterien

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

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Confirmed Objective Response Rate (ORR) (Time Frame - Up to approximately 30 months)

Secondary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to approximately 30 months)

2. Overall Survival (OS) (Time Frame - Up to approximately 30 months)

3. Duration of Response (DOR) (Time Frame - Up to approximately 30 months)

4. PFS (Time Frame - 6 months and 12 months)

5. OS (Time Frame - 6 months, 12 months, and 18 months)

6. Disease Control Rate (DCR) (Time Frame - Up to 12 weeks)

7. Time to Confirmed Deterioration (TTCD) (Time Frame - Baseline up to 3 weeks)

8. Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores (Time Frame - Up to approximately 30 months)

9. Maximum Concentration (Cmax) of Tobemstomig (Time Frame - Up to approximately 30 months)

10. Time of Maximum Concentration (Tmax) of Tobemstomig (Time Frame - Up to approximately 30 months)

11. Clearance (CL) of Tobemstomig (Time Frame - Up to approximately 30 months)

12. Volume of Distribution at Steady State (Vss) of Tobemstomig (Time Frame - Up to approximately 30 months)

13. Area Under the Curve (AUC) of Tobemstomig (Time Frame - Up to approximately 30 months)

14. Half-Life (T1/2) of Tobemstomig (Time Frame - Up to approximately 30 months)

15. Maximum serum concentration (Cmax) of tiragolumab (Time Frame - Up to approximately 30 months)

16. Minimum serum concentration (Cmin) of tiragolumab (Time Frame - Up to approximately 30 months)

17. Cmax of atezolizumab (Time Frame - Up to approximately 30 months)

18. Cmin of atezolizumab (Time Frame - Up to approximately 30 months)

19. Incidence of Anti-Drug Antibodies (ADAs) (Time Frame - Up to approximately 30 months)

Studien-Arme

Active Comparator: Arm A
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
Experimental: Arm B
Participants will receive IV tobemstomig Q3W.
Experimental: Arm C
Participants will receive IV tobemstomig + IV tiragolumab Q3W.

Geprüfte Regime

Atezolizumab:
Participants will receive 1200 mg IV atezolizumab Q3W.
Tobemstomig (RO7247669):
Participants will receive 600 mg IV tobemstomig Q3W.
Tiragolumab:
Participants will receive 600 mg IV tiragolumab Q3W.

Quelle: ClinicalTrials.gov

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"A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer"

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