Actively Recruiting
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
Led by The Netherlands Cancer Institute · Updated on 2025-09-03
90
Participants Needed
9
Research Sites
232 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment
CONDITIONS
Official Title
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Age 18 years or older
- Resectable muscle-invasive urothelial carcinoma of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0 with confirmed lymph node positivity
- Surgical removal of the bladder (cystectomy) is recommended and accepted by the patient
- Patients are either ineligible for cisplatin or choose not to undergo cisplatin-based chemotherapy
- World Health Organization performance status 0 or 1
- Urothelial cancer is the main type of tumor (over 50%), with no small cell or adenocarcinoma components
- Available tumor tissue samples from diagnostic surgery
- Laboratory values within specified safety ranges
- Negative pregnancy test for women of childbearing potential within 2 weeks before treatment
- Use of highly effective contraception if there is a risk of pregnancy
You will not qualify if you...
- Active autoimmune disease within the past 2 years, except for mild skin diseases or controlled diabetes or thyroid conditions
- History of severe autoimmune disease such as inflammatory bowel disease or myasthenia gravis
- Prior intravenous systemic therapy or radiotherapy for urothelial cancer
- Upper urinary tract disease unless planned for removal during bladder surgery
- Previous immunotherapy targeting CTLA-4, LAG3, or PD-1/PD-L1
- Active infections including HIV (unless well controlled), tuberculosis, hepatitis B or C
- Medical conditions or medications that could make study treatment unsafe or interfere with side effect assessment
- Use of other investigational drugs before this study
- Other cancers within the past 2 years with high recurrence risk, except low-risk prostate cancer under surveillance
- Pregnant or breastfeeding women
- Major surgery within 4 weeks before enrollment or planned during the study
- Severe infections within 2 weeks before enrollment
- Significant heart disease or recent heart attack or unstable heart conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Rijnstate
Arnhem, Gelderland, Netherlands, 6815AD
Not Yet Recruiting
2
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
3
NKI-AVL
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
4
Amsterdam UMC (AUMC)
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
5
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2143TM
Actively Recruiting
6
ISALA
Zwolle, Overijssel, Netherlands, 8025AB
Not Yet Recruiting
7
Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
8
Erasmus Medical Center
Rotterdam, Zuid_Holland, Netherlands, 3015GD
Actively Recruiting
9
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
M
Michiel Van der Heijden, PhD
CONTACT
H
Hamza Ali, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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