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Urologic NeoplasmsPhase 2TURANDORELANCT06237920

Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

A Phase 2 study testing Nivolumab and Relatlimab in people with Urologic Neoplasms and Urogenital Neoplasms, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Relatlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
9 sitesNetherlands
Study dates
19 Feb 2024to 1 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent
  • Age ≥ 18 years
  • Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.
  • Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.
  • 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.
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  • Urothelial cancer is the dominant histology (>50%). Any component of small cell or 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, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, GFR>30 ml/min, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN
  • Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.
  • 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)

Who cannot join

  • 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).
  • Previous intravenous systemic therapy or radiotherapy for UC.
  • Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. 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:
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  • 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.
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Netherlands9 sites

  • NKI-AVL

    Amsterdam, North Holland, 1066CX

  • Amsterdam UMC (AUMC)

    Amsterdam, North Holland, 1081HV

  • Rijnstate

    Arnhem, Gelderland, 6815AD

  • Spaarne Gasthuis

    Hoofddorp, North Holland, 2143TM

  • Leiden University Medical Center (LUMC)

    Leiden, South Holland, 2333ZA

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525GA

  • Erasmus Medical Center

    Rotterdam, Zuid_Holland, 3015GD

  • University Medical Center Utrecht

    Utrecht, 3584CX

  • ISALA

    Zwolle, Overijssel, 8025AB

Other trials in Netherlands

About this study

Official title: A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

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

Read the detailed description

This is a phase 2 study in which ninety adult patients with cT2-4aN0 or cT1-4aN1urothelial bladder cancer will be included.

Included patients will be treated with two cycles of checkpoint inhibition with nivolumab or two cycles of nivolumab+relatlimab every 28 days.

Response of this induction therapy will be evaluated by cystoscopy, mpMRI and a CT scan.

The primary endpoint is efficacy, defined as pathological complete response (pCR) defined as pT0N0 or pTisN0 at cystectomy.

Secondary end-points consist of feasibility analysis, defined as percentage of patients completing cystectomy within 12 weeks of start of treatment. Other key secondary end points are drug safety and overall and event-free survival. Events consist of death by any cause; disease recurrence inside or outside the urinary tract and switching to other treatments.

The first evaluation after completion of both treatment cycles will be after six months. Further follow-up visits will take place at 12 and 24 months after completion of the treatment. During these visits, focused physical examination, cystoscopy and a CT chest-abdomen will be performed, combined with registration of treatment-related adverse events and a questionnaire for evaluating QoL, bladder function and long-term effects of immunotherapy on QoL.

Being tested
Nivolumab, Relatlimab
Keywords
Nivolumab, Relatlimab
Medical subject headings
Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Urinary Bladder Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    Induction with immune checkpoint blockade nivolumab on day 1. Nivolumab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.

  • RelatlimabDrug

    Also called BMS-986016

    Induction with immune checkpoint blockade nivolumab and relatlimab on day 1. Nivolumab and relatlimab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.

Study groups in NCT06237920
Study groupRoleWhat they receive
NivolumabExperimental1 cycle of intravenous nivolumab on day 1 and 1 cycle of intraveous nivolumab on day 29. Total administration frequency is twice.
Receives: Drug: Nivolumab
Nivolumab and relatlimabExperimental1 cycle of intravenous nivolumab and relatlimab on day 1 and 1 cycle of intraveous nivolumab and relatlimab on day 29. Total administration frequency is twice.
Receives: Drug: Nivolumab; Drug: Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response

    Pathological complete response defined as pT0N0 or pTisN0 in all evaluable patients

    Measured: Immediately after surgery

Secondary outcomes (6)

  1. Drug toxicity

    Safety in terms of immunotherapy-related adverse events according to CTCAE 5.0 criteria

    Measured: Immunotherapy-related adverse events will be noted from time of immunotherapy start at day 1 throughout the study, up to 24 weeks after surgery.

  2. Feasibility of dual immunotherapy

    Percentage of patients that completes cystectomy within 12 weeks of start of treatment. Patients who elect to not undergo surgery or have a delay due to logistical reasons not related to study treatment will be excluded from this analysis.

    Measured: [Time Frame: From initiation of study drug until surgery, which will take place between day 50-71 after initiation of study drug]

  3. Tumor tissue biomarkers predicting treatment response

    PD-L1 expression of tumor tissue (obtained pre-treatment) will be determined using immunohistochemistry of tissue slides. For PD-L1, tumor proportion score (TPS) will be determined. Pathological complete response will be related to PD-L1 expression

    Measured: 12 weeks after immunotherapy administration

  4. Exploring the Immunological effects of immunotherapy on the tumor microenvironment

    RNA sequencing and multiplex immunofluorescence will be carried out on TUR and cystectomy tumor tissue. Methods may include RNA expression profiling and multiplex immunofluorescence.

    Measured: 21 weeks after the last patient has started treatment

  5. Event-free survival

    Event-free survival is a composite endpoint, defined by the time from randomization to occurrence of any of the events below:

    • Disease recurrence outside the urinary tract (distant metastases, pelvic recurrence).
    • Disease progression precluding surgery.
    • Muscle invasive recurrence in the bladder or distal ureters in case surgery is not performed for other reasons than progression.
    • Switch to other treatments pre- or post-surgery directed at systemic UC (e.g. platinum-based chemotherapy combinations, antibody-drug conjugates etc.). In case adjuvant chemotherapy or immunotherapy is administered without evidence of residual disease, patients will be censored at the start of adjuvant therapy. Locoregional therapy to the bladder, such as (chemo)radiotherapy will not be considered an event in the absence of progressive disease.

    Measured: Through study completion, an average of 2 years

  6. Overall survival

    OS is defined as the time between the date of enrollment and the date of death

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start19 Feb 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06237920
Sponsor's protocol ID
M23TRR
Acronym
TURANDORELA
Status last verified
Jul 2026
First submitted
10 Nov 2023
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Relatlimab in people with Urologic Neoplasms and Urogenital Neoplasms, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06237920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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