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A phase 2 study to investigate the effectiveness of combination immunotherapy followed by chemoradiation of the tumor in patients with bladder cancer (Indi-blade).
EU CTIS ID: 2024-512211-41-00
What this study is testing
To establish efficacy of induction ipilimumab + nivolumab followed by CRT by determining bladder-intact event-free survival (BI-EFS) for the intention-to-treat population. Events are defined as: - Muscle-invasive recurrence in the bladder or in the ureter, distal of the crossing with the common iliac artery - Nodal or distant recurrence - Cystectomy - Death by any cause - Switch to cisplatin-based chemotherapy
- Phase I and Phase II (Integrated)- Other
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
- Highly effective contraception for both male and female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 4.4 Pregnancy, contraception and breastfeeding)
- Age ≥ 18 years
- Patients with cT2-4aN0-2M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and/or patients who are medically unfit for surgery. Patients with suspected metastatic disease are not eligible.
- Lymph node metastases should be amenable for inclusion into the radiation field according to the multidisciplinary tumor board and/or follow-up consultations between the treating physician and the radiation oncologist.
- World Health Organization (WHO) performance Status 0 or 1.
You likely can't join if
- Previous pelvic irradiation
- Known history of Human Immunodeficiency Virus, active tuberculosis, or other active infection requiring therapy at the time of inclusion.
- Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- 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 four weeks or five half-lives before study drug administration
See the full eligibility criteria
Who can join
- Willing and able to provide informed consent
- Highly effective contraception for both male and female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 4.4 Pregnancy, contraception and breastfeeding)
- Age ≥ 18 years
- Patients with cT2-4aN0-2M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and/or patients who are medically unfit for surgery. Patients with suspected metastatic disease are not eligible.
- Lymph node metastases should be amenable for inclusion into the radiation field according to the multidisciplinary tumor board and/or follow-up consultations between the treating physician and the radiation oncologist.
- World Health Organization (WHO) performance Status 0 or 1.
- Urothelial cancer is the dominant histology (>70%). A small cell component 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 as per Cockcroft-Gault formula, AST ≤ 2.5 x ULN, ALT ≤2.5 x ULN, Bilirubin ≤1.5 X ULN with an exception for patients with Gilbert’s syndrome (Bilirubin ≤2 X ULN)
- Negative pregnancy test (βHCG in urine or blood) for female patients of childbearing potential within 2 weeks prior to day 1 of start immunotherapy.
What rules you out
- Previous pelvic irradiation
- Known history of Human Immunodeficiency Virus, active tuberculosis, or other active infection requiring therapy at the time of inclusion.
- Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- 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 four weeks or five half-lives before study drug administration
- 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 pelvic 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.
- Upper tract urothelial cancer
- Extensive carcinoma in situ (CIS) of the bladder
- Bilateral hydronephrosis
- Previous intravenous chemotherapy for bladder cancer
- Contra-indication to one of the study treatment components, or mpMRI
- 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.
- Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).
- Prior CTLA-4 or PD-(L)1 -targeting immunotherapy.
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.