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Study of RO7247669, Tiragolumab, and Atezolizumab for Patients with Untreated Advanced Urothelial Cancer Ineligible for Platinum Chemotherapy

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What is this study about?

This clinical trial is focused on studying treatments for urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study involves three different treatments: RO7247669, tiragolumab, and atezolizumab. RO7247669 is also known by the code name TOBEMSTOMIG. These treatments are types of immunotherapy, which help the body’s immune system fight cancer.

The purpose of the study is to evaluate how effective these treatments are in patients who have not received any previous treatment for their advanced or metastatic urothelial cancer and are not eligible for chemotherapy that contains platinum. The study will compare the effects of RO7247669 alone, RO7247669 combined with tiragolumab, and atezolizumab alone. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment. The study will look at how many participants experience a reduction in their cancer, how long it takes for the cancer to progress, and overall survival rates. The study will also track any side effects that participants may experience. This research aims to find the most effective treatment option for patients with this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including performance status and medical history related to urothelial cancer.

A representative tumor specimen is required for analysis to determine specific markers.

2 randomization

Participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

3 treatment administration

Participants receive treatment through intravenous infusion. The specific treatment depends on the group assigned during randomization.

The treatments include atezolizumab, RO7247669, and tiragolumab, either alone or in combination. The dosage and frequency are determined by the study protocol.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure the size and progression of the cancer.

Participants are also monitored for any side effects or adverse reactions to the treatment.

5 follow-up evaluations

Follow-up evaluations are scheduled to continue monitoring the participant’s health and the effectiveness of the treatment.

These evaluations help determine the overall response rate and progression-free survival.

6 completion of study participation

Upon completion of the study, participants may undergo final assessments to gather data on long-term outcomes and any lasting effects of the treatment.

Who Can Join the Study?

  • The patient must have previously untreated locally advanced or metastatic urothelial cancer. This means the cancer has not been treated before and has spread to nearby areas or other parts of the body.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less. This is a scale that measures how well a patient can perform daily activities, with lower numbers indicating better ability.
  • The patient must have a type of cancer called transitional cell carcinoma (TCC) of the urothelium, which is the lining of the bladder and other parts of the urinary tract. The cancer must have a urothelial component, even if it has other types of cells.
  • The patient must be considered ineligible or “unfit” to receive platinum-based chemotherapy. This could be due to certain health conditions or the patient’s ability to handle chemotherapy.
  • The patient must not have had any prior chemotherapy for inoperable locally advanced, metastatic, or recurrent urothelial carcinoma.
  • The patient must have measurable disease, meaning there is at least one tumor that can be measured to see if it changes in size during the study.
  • The patient must provide a tumor specimen that can be used to check for certain markers, like PD-L1 status, which helps in understanding the cancer better and planning treatment.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, meaning they might need extra protection or care during the study.

Who Cannot Join the Study?

  • Patients who have already received treatment for their urothelial cancer cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned, cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients with certain heart conditions that are not well controlled cannot participate.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Hospital Universitario 12 De Octubre Madrid Spain
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Alexandra Hospital Athens Greece
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
University Hospital Consorziale Policlinico Bari Italy
Csgqto Lgid Banogb Lyon France
Uhuqdopppy Mhmpmoq Ccdtwz Heruecnarozektrmf Hamburg Germany
Ieztjljr Czmhiy Drswmvypemakncjgc L'hospitalet De Llobregat Spain
Thvmdrkpth Cqwgds Hmuugrae Thessaloniki Greece
Hrnnak Hfxrduja Herlev Denmark
Ihlftren Rjkbljosj Pba Lf Sbwqbp Dlj Tiidmr Dyvl Aoevlsc Iyix Spmtuq Meldola Italy
Uehwtvgopmkdgpjefssbs Davcpcfnldl Anc Duesseldorf Germany
Amgmno Ulwwadgntk Hmcqyjnb Aarhus Denmark
Amtnkuv Ungux Sjmpezmes Lfwfon Dy Bevzmzn Bologna Italy
Fearfuuwx Pdqt Lx Icqdaxbwzsapg Bmooakhom Dpx Hkciwtwe Uysabyzxigzyk Lq Ptg Madrid Spain
Hmqhwuju Vrbu dtfsoryx Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
31.05.2023
France France
Not recruiting
31.05.2023
Germany Germany
Not recruiting
31.05.2023
Greece Greece
Not recruiting
31.05.2023
Italy Italy
Not recruiting
31.05.2023
Poland Poland
Not recruiting
31.05.2023
Spain Spain
Not recruiting
31.05.2023

Trial locations

Investigated drugs:

RO7247669 is an investigational medication being studied for its potential to treat urothelial cancer. It is being tested to see how well it works on its own and in combination with another medication. Researchers are looking at how effective it is in shrinking tumors or stopping them from growing.

Tiragolumab is another investigational medication used in this study. It is being combined with RO7247669 to see if the combination is more effective than using RO7247669 alone. The goal is to determine if this combination can improve the treatment outcomes for patients with urothelial cancer.

Atezolizumab is an approved medication that is used as a comparison in this study. It is a type of immunotherapy that helps the immune system attack cancer cells. The study aims to compare the effectiveness of RO7247669, both alone and in combination with tiragolumab, against atezolizumab in treating urothelial cancer.

Investigated diseases:

Urothelial Cancer – Urothelial cancer is a type of cancer that typically begins in the cells lining the bladder, but it can also occur in other parts of the urinary tract. It is characterized by the abnormal growth of cells in the urothelium, which is the tissue lining the bladder and other parts of the urinary system. The disease can be classified as either non-invasive, where the cancer cells are confined to the inner layer of the bladder, or invasive, where the cancer has spread into the muscle layer or beyond. In its advanced stages, the cancer may spread to nearby tissues or distant organs, a process known as metastasis. Symptoms often include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining localized while others become more aggressive and spread to other parts of the body.

Trial ID:
2023-504027-78-00
Protocol code:
BO44157
Trial Phase:
Therapeutic exploratory (Phase II)

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