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Non-muscle Invasive Bladder CancerPhase 1NCT06816017

A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

A Phase 1 study testing Eciskafusp Alfa and BCG Medac Strain in people with Non-muscle Invasive Bladder Cancer, run by Hoffmann-La Roche at 9 sites in 6 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with BCG in participants with BCG-unresponsive high-risk NMIBC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
Eciskafusp Alfa and BCG Medac Strain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
9 sitesin 6 countries
Study dates
15 Jun 2025to 31 Oct 2030
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system
  • Absence of resectable disease after transurethral resection of bladder tumor (TURBT) procedures
  • The most recent cystoscopy/TURBT must have been performed within 12 weeks and up to 14 days of the first dose of study treatment
  • Presence of BCG-unresponsive disease defined as persistent or recurrent carcinoma in situ [CIS] (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy
  • The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure.
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Positive hepatitis B surface antibody (HBsAb) test at screening
  • Negative hepatitis C virus (HCV) antibody test at screening

Who cannot join

  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Active infections (both systemic and local urinary)
  • Congenital or acquired immune deficiencies resulting in immunosuppression
  • Known human immunodeficiency virus (HIV) infection
  • History of radiotherapy of the bladder
  • History of perforation of the bladder
Show all 13Show fewer
  • Major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment
  • Participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, and supportive care therapies for active disease
  • Any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/TURBT to the start of study treatment
  • Systemic immune-modulating and systemic immunosuppressive agents/medication
  • Administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment
  • Recurrence of BCG unresponsive CIS > 12 months after last BCG instillation
  • Concurrent second malignancy

Trial locations and contacts

9 sites in 6 countries.

9 sites in 6 countries

Netherlands2 sites

  • NKI/AvL

    Amsterdam, 1066 CX

  • UMC St Radboud

    Nijmegen, 6525 GA

Other trials in Netherlands

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

  • AIDPORT Sp. z o. o.

    Skórzewo, 60-185

Other trials in Poland

Spain2 sites

  • Hospital Univ. 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

Australia1 site

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2113

Other trials in Australia

Italy1 site

  • A.O.U di Verona Policlinico G.B. Rossi

    Verona, Veneto, 37134

Other trials in Italy

Malaysia1 site

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586

Other trials in Malaysia

About this study

Official title: A Phase I/II, Open-label, Dose Escalation and Extension Study of Intravesical Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with BCG in participants with BCG-unresponsive high-risk NMIBC.

The study plans a similar evaluation of eciskafusp alfa in monotherapy following a positive interim analysis of the combination therapy.

Being tested
Eciskafusp Alfa, BCG Medac Strain
Keywords
BCG-unresponsive Non-muscle Invasive Bladder Cancer
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

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

  • Eciskafusp AlfaDrug

    Also called RO7284755

    Participants will receive eciskafusp alfa via intravesical instillation.

  • BCG Medac StrainDrug

    Participants will receive BCG via intravesical instillation.

Study groups in NCT06816017
Study groupRoleWhat they receive
Phase I: Dose EscalationExperimentalParticipants will receive multiple ascending doses of eciskafusp alfa in combination with a fixed dose of BCG administered as an intravesicular instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.
Receives: Drug: Eciskafusp Alfa; Drug: BCG Medac Strain
Phase II: Dose Extension (Cohort A)ExperimentalParticipants will receive eciskafusp alfa at the maximum tolerated dose (MTD) and/or the recommended dose for extension (RDE), as determined in Phase 1, in combination with a fixed dose of BCG administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.
Receives: Drug: Eciskafusp Alfa; Drug: BCG Medac Strain
Phase II: Dose Extension (Cohort B)ExperimentalParticipants will receive eciskafusp alfa as monotherapy at the MTD or RDE determined in Phase 1, administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.
Receives: Drug: Eciskafusp Alfa

What is being measured

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

  1. Phase I: Number of Participants With Adverse Events (AEs)

    Measured: From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26)

  2. Phase I: Number of Participants With Dose Limiting Toxicities (DLTs)

    Measured: From Day 1 up to Day 14

  3. Phase I: Recommended Dose for Extension (RDE) of Eciskafusp Alfa in Combination With BCG

    Measured: At Month 25

  4. Phase II (Cohort A): Complete Response Rate (CRR) at 12 Months

    Measured: At Month 12

Secondary outcomes (14)

  1. Phase I and Phase II: CRR at any Time

    Measured: Up to Month 36

  2. Phase I and Phase II: CRR at 6, 18 and 24 Months

    Measured: At Months 6, 18 and 24

  3. Phase I and Phase II (Cohort B): CRR at 12 Months

    Measured: At Month 12

  4. Phase I and Phase II: Duration of Response (DOR)

    Measured: Time from the first occurrence of a documented CR until the time of evidence that the participant no longer meets the definition for CR or death from any cause, whichever occurs first (up to Month 36)

  5. Phase I and Phase II: DOR Rate at Specific Timepoints

    Measured: At Months 6, 12, 18, 24, 30 and 36

  6. Phase I and Phase II: Time to Worsening of NMIBC Grade or Stage, or Death

    Measured: Time from the first dose of study treatment to the first occurrence of documented worsening of grade, stage or death from any cause, whichever occurs first (up to Month 36)

  7. Phase I and Phase II: Progression Free Survival (PFS) to Muscle Invasive or Metastatic Disease or Death

    Measured: Time from the first dose of study treatment to the first occurrence of documented muscle-invasive or metastatic disease or death from any cause, whichever occurs first (up to Month 36)

  8. Phase I and II: Time to Cystectomy

    Measured: Time from the first dose of study treatment to the first occurrence of documented cystectomy or death from any cause, whichever occurs first (up to Month 36)

  9. Phase II: Number of Participants With AEs

    Measured: From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26)

  10. Phase I and Phase II: Number of Participants With Anti-drug Antibodies (ADAs) to Eciskafusp Alfa

    Measured: Up to Month 36

  11. Phase II: Programmed Cell Death Ligand 1 (PD-L1) Expression in the Tumor Microenvironment (TME) Pre-treatment and During the Study

    PD-L1 expression may be assessed at other timepoints when on-treatment biopsies will be collected.

    Measured: Predose (-12 weeks to -14 days or archival) and Postdose at Month 6

  12. Phase II: Number of Participants With Cluster of Differentiation 8+ (CD8+) T cell in TME

    Measured: Predose (-12 weeks to -14 days or archival)

  13. Phase II: Baseline Urine Tumor Deoxyribonucleic Acid (DNA)

    Measured: Baseline (Day 1 predose)

  14. Phase II: Amount of Urine Tumor DNA at Baseline and During the Study

    Measured: Up to Month 25

Timeline

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

  1. First posted10 Feb 2025
  2. Study start15 Jun 2025 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Why it stopped: Decision of the Sponsor.

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06816017
Sponsor's protocol ID
BP45381
Other IDs
2024-515410-41-00
Status last verified
Jun 2025
First submitted
4 Feb 2025
Last updated
16 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eciskafusp Alfa and BCG Medac Strain in people with Non-muscle Invasive Bladder Cancer, run by Hoffmann-La Roche at 9 sites in 6 countries.

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 8 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 Jun 2025. 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, Poland, Spain, Australia, Italy and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Phase I: Number of Participants With Adverse Events (AEs) (time frame: From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26)). The study lists 4 primary outcomes in all. 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 NCT06816017.

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 16 Jun 2025.

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