GemRIS (gemcitabine-releasing intravesical system)

P3, N=250, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting

P3, N=1050, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2030 --> Sep 2029

P3, N=1050, Recruiting, Janssen Research & Development, LLC | Trial completion date: May 2030 --> Sep 2030

P2, N=160, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Dec 2023 --> Dec 2026

P3, N=1050, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: May 2030 --> Sep 2029

P3, N=250, Not yet recruiting, Janssen Research & Development, LLC

P2, N=200, Recruiting, Janssen Research & Development, LLC | Phase classification: P2b --> P2

P3, N=550, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2028 --> Dec 2029

P2, N=160, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> Mar 2027

P2b, P3 | "Secondary end points include overall complete response rate (CIS only), recurrence-free survival, time to progression, overall survival, cancer-specific survival, safety, and pt-reported outcomes. As of May 3, 2023, 1 pt has been randomized, with 16 in screening; recruitment is planned at 254 sites."

This activity is supported by educational grants from Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC. Selection of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) for pembrolizumab therapy Ongoing Phase III trials investigating the combination of BCG and anti-PD-1/PD-L1 antibodies for BCG-naïve and BCG-unresponsive NMIBC Rates of pathologic complete response and other clinically relevant endpoints achieved in early trials evaluating neoadjuvant anti-PD-1/PD-L1 antibody therapy for resectable muscle-invasive bladder cancer (MIBC) Key efficacy and safety data from the Phase III CheckMate 274 trial comparing nivolumab to placebo after radical surgery for high-risk MIBC Optimal integration of adjuvant nivolumab into clinical practice and identification of appropriate candidates Ongoing Phase III studies evaluating anti-PD-1/PD-L1 antibodies combined with chemotherapy, chemoradiation therapy, other immune checkpoint inhibitors or targeted therapies for patients with MIBC Mechanism of antitumor activity of and early data with the novel intravesical drug delivery system TAR-200 Design, eligibility criteria and key endpoints of the Phase II SunRISe-1 study evaluating TAR-200 and cetrelimab, TAR-200 alone or cetrelimab alone for patients with BCG-unresponsive high-risk NMIBC who are ineligible for or decline radical cystectomy; complete response rates reported with TAR-200 monotherapy and cetrelimab monotherapy Ongoing studies of TAR-200 with and without cetrelimab for NMIBC (eg, SunRISe-3) and MIBC (eg, SunRISe-2, SunRISe-4)

P2, N=160, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Apr 2023 --> Dec 2023

TAR-200 was generally safe, well tolerated, and demonstrated preliminary efficacy in this elderly and frail cohort with limited treatment options. TAR-200 is currently under investigation in combination with the systemic inhibitor of programmed cell death protein-1 cetrelimab in the SunRISe clinical trials program (NCT04640623, NCT04658862, NCT04919512).

GemRIS is an implantable novel form of intravesical drug delivery of gemcitabine and is currently being investigated with cetrelimab, a checkpoint inhibitor, in patients with high-risk NMIBC and MIBC...Nadofaragene firadenovec (rAd-IFN-α/Syn3) is a recombinant adenovirus that induces release of interferon-alpha in the urothelium...N-803 is an interleukin (IL)-15 analogue, which has been investigated in a phase 1b study in combination with BCG and has shown durable complete response in all nine patients for 72 months. It was granted breakthrough designation status by the FDA in 2019.

The TAR-200 system was generally safe and well tolerated in this elderly and frail cohort of patients with MIBC. TEAEs observed during the study were consistent with what would be expected in this patient population with lethal bladder cancer, with no unanticipated safety issues attributed to treatment with TAR-200. Procedural interventions in this high-risk cohort were modest.

P1b, N=12, Completed, Taris Biomedical LLC | Active, not recruiting --> Completed

P1b, N=22, Completed, Taris Biomedical LLC | Active, not recruiting --> Completed | Trial completion date: Oct 2019 --> May 2019