A study comparing TAR-210 versus single agent treatment instilled directly into the bladder in people with bladder cancer with FGFR gene alterations.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Jul 2024 → ongoing

Decision date (initial)

2024-06-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenomic, Pharmacodynamic, Therapy, Efficacy, Pharmacokinetic, Others

To compare DFS between Group A and Group B.

Conditions and MedDRA coding

FGFR+ Intermediate-risk Non-muscle Invasive Bladder Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: • Ta LG/G1: primary or recurrent • Ta LG/G2: primary or recurrent And ≥1 of the following risk factors: • Multiple Ta LG tumors • Solitary LG tumor ≥3 cm • Early recurrence (≤1 year) • Frequent recurrence (>1 per year) • Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) Note: Mixed histology tumors are allowed if percentage of variant histology and subtype of variant histology are consistent with an LG tumor.
2. Have a susceptible FGFR mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
3. Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy.

Exclusion criteria 5

1. Histologically confirmed diagnosis of HR NMIBC (defined as HG/G2 or HG/G3 Ta and T1, or CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
2. Has or had urothelial carcinoma outside of the urinary bladder (ie, urethra, ureter, or renal pelvis, N+, M+) or has a histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and without any evidence of disease following nephroureterectomy.
3. Received an investigational treatment for bladder cancer after TURBT for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study.
4. Received adjuvant intravesical chemotherapy within 6 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy per institutional guidelines (is not considered adjuvant therapy (and no washout period is required for this single dose).
5. Received prior treatment with an FGFR inhibitor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 14

Locations

10 EU/EEA countries · 76 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 176 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications