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Authors
Soma, Takahiko https://orcid.org/0000-0002-7086-8214
Takemura, Kosuke https://orcid.org/0000-0003-4321-6074
Toide, Masahiro https://orcid.org/0000-0002-0623-3695
Ito, Masaya https://orcid.org/0000-0002-0230-6367
Koga, Fumitaka https://orcid.org/0000-0001-7888-0085
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04640623 at ClinicalTrials.govnct04452591 at ClinicalTrials.govDocuments that mention this clinical trial
Reasons for refusal of or ineligibility for radical cystectomy (RC) in patients (Pts) with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) from the SunRISe-1 study.
https://doi.org/10.1200/jco.2024.42.4_suppl.701
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04752722 at ClinicalTrials.govDocuments that mention this clinical trial
426 A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)
https://doi.org/10.1136/jitc-2021-sitc2021.426
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct03317158 at ClinicalTrials.govDocuments that mention this clinical trial
A phase 1/2 study of detalimogene voraplasmid (EG-70) intravesical monotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC).
https://doi.org/10.1200/jco.2025.43.5_suppl.tps886
441 Reimagining bladder cancer immunotherapy: local non-viral gene delivery of DNA-encoded immune checkpoint inhibitors
https://doi.org/10.1136/jitc-2025-sitc2025.0441
Clinical results of a phase 1 study of intravesical EG-70 in patients with BCG-unresponsive NMIBC.
https://doi.org/10.1200/jco.2023.41.6_suppl.512
Preliminary results from LEGEND: A phase 2 study of detalimogene voraplasmid (EG-70), a novel, non-viral intravesical gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
https://doi.org/10.1200/jco.2025.43.5_suppl.802
A phase 1/2 study of EG-70 (detalimogene voraplasmid) intravesical monotherapy for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
https://doi.org/10.1200/jco.2024.42.16_suppl.tps4626
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
993 Mechanism of action and translation to the clinic of EG-70 – a novel, investigational non-viral immunotherapy for non-muscle-invasive bladder cancer
https://doi.org/10.1136/jitc-2024-sitc2024.0993
nct03892642 at ClinicalTrials.govDocuments that mention this clinical trial
A phase 1/2 trial of durvalumab plus intravesical gemcitabine and docetaxel in BCG-unresponsive non-muscle invasive bladder cancer patients (HCRN GU16-243: ADAPT-BLADDER Cohort 4).
https://doi.org/10.1200/jco.2025.43.5_suppl.667
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04172675 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04172675 at ClinicalTrials.govDocuments that mention this clinical trial
Phase 2 study of the efficacy and safety of erdafitinib in patients (pts) with intermediate-risk non–muscle-invasive bladder cancer (IR-NMIBC) with <i>FGFR3/2</i> alterations (alt) in THOR-2: Cohort 3 interim analysis.
https://doi.org/10.1200/jco.2023.41.6_suppl.504
Phase 2 study of the efficacy and safety of erdafitinib in patients (pts) with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with <i>FGFR3/2</i> alterations (<i>alt</i>) in THOR-2: Cohort 2 interim analysis results.
https://doi.org/10.1200/jco.2023.41.6_suppl.503
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02449239 at ClinicalTrials.govDocuments that mention this clinical trial
Phase 2 study of the efficacy and safety of erdafitinib in patients (pts) with intermediate-risk non–muscle-invasive bladder cancer (IR-NMIBC) with <i>FGFR3/2</i> alterations (alt) in THOR-2: Cohort 3 interim analysis.
https://doi.org/10.1200/jco.2023.41.6_suppl.504
Phase 2 study of the efficacy and safety of erdafitinib in patients (pts) with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with <i>FGFR3/2</i> alterations (<i>alt</i>) in THOR-2: Cohort 2 interim analysis results.
https://doi.org/10.1200/jco.2023.41.6_suppl.503
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06388720 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct01259063 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04640623 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06211764 at ClinicalTrials.govDocuments that mention this clinical trial
Reasons for refusal of or ineligibility for radical cystectomy (RC) in patients (Pts) with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) from the SunRISe-1 study.
https://doi.org/10.1200/jco.2024.42.4_suppl.701
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct07000084 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct05024773 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06663137 at ClinicalTrials.govDocuments that mention this clinical trial
A phase III single-arm study to evaluate the efficacy and safety of paclitaxel-hyaluronic acid conjugate administered intravesically to patients with BCG-unresponsive carcinoma in situ of the bladder with or without Ta-T1 papillary disease (Orion-BC study).
https://doi.org/10.1200/jco.2025.43.5_suppl.tps885
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02982395 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06732531 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04498702 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04490993 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02773849 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06545955 at ClinicalTrials.govDocuments that mention this clinical trial
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer
https://doi.org/10.1136/jitc-2021-002552
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06929286 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
ABLE-22: Safety and efficacy evaluation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy—A randomized, open-label, phase 2 study.
https://doi.org/10.1200/jco.2025.43.5_suppl.tps891
nct04452591 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04387461 at ClinicalTrials.govDocuments that mention this clinical trial
426 A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)
https://doi.org/10.1136/jitc-2021-sitc2021.426
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06567743 at ClinicalTrials.govDocuments that mention this clinical trial
955 CORE1: phase 2, single arm study of CG0070 combined with pembrolizumab in patients with non muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guerin (BCG)
https://doi.org/10.1136/jitc-2021-sitc2021.955
Final results of CORE-001: A phase-2, single arm study of cretostimogene grenadenorepvec in combination with pembrolizumab in patients with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ.
https://doi.org/10.1200/jco.2024.42.16_suppl.4601
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04752722 at ClinicalTrials.govDocuments that mention this clinical trial
CORE-008: A phase 2, multi-arm, multi-cohort, open-label study to evaluate intravesical cretostimogene grenadenorepvec in participants with high-risk non-muscle invasive bladder cancer.
https://doi.org/10.1200/jco.2025.43.5_suppl.tps901
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06255964 at ClinicalTrials.govDocuments that mention this clinical trial
A phase 1/2 study of detalimogene voraplasmid (EG-70) intravesical monotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC).
https://doi.org/10.1200/jco.2025.43.5_suppl.tps886
441 Reimagining bladder cancer immunotherapy: local non-viral gene delivery of DNA-encoded immune checkpoint inhibitors
https://doi.org/10.1136/jitc-2025-sitc2025.0441
Clinical results of a phase 1 study of intravesical EG-70 in patients with BCG-unresponsive NMIBC.
https://doi.org/10.1200/jco.2023.41.6_suppl.512
Preliminary results from LEGEND: A phase 2 study of detalimogene voraplasmid (EG-70), a novel, non-viral intravesical gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
https://doi.org/10.1200/jco.2025.43.5_suppl.802
A phase 1/2 study of EG-70 (detalimogene voraplasmid) intravesical monotherapy for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
https://doi.org/10.1200/jco.2024.42.16_suppl.tps4626
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
993 Mechanism of action and translation to the clinic of EG-70 – a novel, investigational non-viral immunotherapy for non-muscle-invasive bladder cancer
https://doi.org/10.1136/jitc-2024-sitc2024.0993
nct04799847 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct01200992 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct05232136 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06971614 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02625961 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct03711032 at ClinicalTrials.govDocuments that mention this clinical trial
Phase 2 KEYNOTE-057 cohort C: Pembrolizumab (pembro) with vibostolimab or favezelimab for patients (pts) with high-risk (HR) bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC).
https://doi.org/10.1200/jco.2023.41.6_suppl.tps591
Outcomes of patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer who demonstrated nonresponse to pembrolizumab in KEYNOTE-057: A post hoc analysis.
https://doi.org/10.1200/jco.2024.42.16_suppl.4597
Pembrolizumab with favezelimab or vibostolimab for patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk (HR) non–muscle-invasive bladder cancer (NMIBC): Phase 2 KEYNOTE-057 cohort C.
https://doi.org/10.1200/jco.2024.42.4_suppl.tps719
Pembrolizumab (pembro) monotherapy for patients (pts) with high-risk non–muscle-invasive bladder cancer (HR NMIBC) unresponsive to bacillus Calmette–Guérin (BCG): Results from cohort B of the phase 2 KEYNOTE-057 trial.
https://doi.org/10.1200/jco.2023.41.6_suppl.lba442
Bladder sparing by short-course radiotherapy combined with toripalimab in high-risk/extremely high-risk non-muscle invasive bladder cancer (HOPE-04): study protocol for a single-arm, prospective, phase II trial
https://doi.org/10.1136/bmjopen-2023-076663
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer
https://doi.org/10.1136/jitc-2021-002552
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02808143 at ClinicalTrials.govDocuments that mention this clinical trial
Phase 3 KEYNOTE-676 cohort A: Bacillus Calmette-Guérin (BCG) with or without pembrolizumab for high-risk (HR) non–muscle-invasive bladder cancer (NMIBC) that persists/recurs after BCG induction.
https://doi.org/10.1200/jco.2024.42.4_suppl.tps722
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer
https://doi.org/10.1136/jitc-2021-002552
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06972615 at ClinicalTrials.govDocuments that mention this clinical trial
Protocol for phase I study of pembrolizumab in combination with Bacillus Calmette-Guérin for patients with high-risk non-muscle invasive bladder cancer
https://doi.org/10.1136/bmjopen-2018-028287
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct03317158 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct04149574 at ClinicalTrials.govDocuments that mention this clinical trial
A phase 1/2 trial of durvalumab plus intravesical gemcitabine and docetaxel in BCG-unresponsive non-muscle invasive bladder cancer patients (HCRN GU16-243: ADAPT-BLADDER Cohort 4).
https://doi.org/10.1200/jco.2025.43.5_suppl.667
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06919965 at ClinicalTrials.govDocuments that mention this clinical trial
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer
https://doi.org/10.1136/jitc-2021-002552
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct05014139 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06551233 at ClinicalTrials.govDocuments that mention this clinical trial
A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104).
https://doi.org/10.1200/jco.2023.41.16_suppl.4596
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
Study EV-104: Phase 1 study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC)—Trial in progress.
https://doi.org/10.1200/jco.2023.41.6_suppl.tps582
nct05996952 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct05943379 at ClinicalTrials.govDocuments that mention this clinical trial
Adjuvant or rescue disitamab vedotin (RC48-ADC) for high-risk non-muscle invasive bladder cancer with HER2 overexpression: A phase II multi-center study.
https://doi.org/10.1200/jco.2024.42.16_suppl.tps4625
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct05957757 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct02449239 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct00981656 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct03950362 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926
https://doi.org/10.1200/jco.23.02510
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct06770582 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct03945162 at ClinicalTrials.govDocuments that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
nct01259063 at ClinicalTrials.govDocuments that mention this clinical trial
A phase II clinical study of intravesical photo dynamic therapy in patients with BCG-unresponsive NMIBC (interim analysis).
https://doi.org/10.1200/jco.2023.41.6_suppl.528
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
Documents that mention this clinical trial
Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette–Guérin failure: a systematic review
https://doi.org/10.1136/bmjonc-2025-000753
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