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A phase 2 trial in stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab - TURANDORELA
EU CTIS ID: 2023-507460-39-00
What this study is testing
Establish efficacy of nivolumab + relatlimab as neo-adjuvant treatment in muscle-invasive and metastatic bladder cancer
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide informed consent
- Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.
- Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.
- Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)
- Age ≥ 18 years
- Resectable muscle-invasive urothelial cancer of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. Note: in cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed
You likely can't join if
- Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.
- Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated >10%). Patients with low-risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
- Pregnant and lactating female patients.
- Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina
See the full eligibility criteria
Who can join
- Willing and able to provide informed consent
- Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.
- Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.
- Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)
- Age ≥ 18 years
- Resectable muscle-invasive urothelial cancer of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. Note: in cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed
- Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria
- World Health Organization (WHO) performance Status 0 or 1
- Urothelial cancer is the dominant histology (>50%). Any component of small cell of adenocarcinoma is not allowed
- Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.
- Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.0x109/L, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, GFR>30 ml/min, AST ≤ 2.5 x ULN, ALT ≤2.5 x ULN, Bilirubin ≤1.5 X ULN
What rules you out
- Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.
- Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated >10%). Patients with low-risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
- Pregnant and lactating female patients.
- Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina
- Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).
- Previous intravenous systemic therapy or radiotherapy for Urothelial cancer.
- Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for Urothelial bladder cancer. This includes non-muscle-invasive disease.
- Prior CTLA-4, LAG3 or PD-1/PD-L1-targeting immunotherapy.
- Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection: - HIV-positive patients are eligible if the following applies: No AIDS defining opportunistic infection within the last year and a current CD4 count >350 cells/uL. Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study CD4 counts and viral load are monitored per standard of care by a local health care provider - In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.
- Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.
- Use of other investigational drugs before study drug administration
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.