ArticleWorld journal of urology2021
Phase I trial of intravesical Bacillus Calmette-Guérin combined with intravenous pembrolizumab in recurrent or persistent high-grade non-muscle-invasive bladder cancer after previous Bacillus Calmette-Guérin treatment.
Article in World journal of urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02324582 (Phase I Study of MK-3475 in Combination With BCG for Patients With High Risk Superficial Bladder Cancer), which is not on this map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I Study of MK-3475 in Combination With BCG for Patients With High Risk Superficial Bladder Cancer
Who cites it
18 citing papers in PubMed, 27 citations in OpenAlex.
- Review
- Combination Strategies to Enhance Bacillus Calmette-Guérin Efficacy for Nonmuscle-Invasive Bladder Cancer.The Journal of urology · 2026Review
- Immune checkpoint inhibitors in BCG-unresponsive non-muscle-invasive bladder cancer: a narrative review of evidence and future directions.Translational andrology and urology · 2026Review
- Vaccination-enabled immune readiness for checkpoint blockade.Frontiers in immunology · 2026Review
- Cancer vaccines as enablers of immunotherapy.Nature immunology · 2025Review
- Efficacy and safety of BCG and immune checkpoint inhibitors in non-muscle invasive bladder cancer: A meta-analysis with exploratory chemotherapy comparisons.Oncology letters · 2025Article
- On the Horizon: A Global Multidisciplinary Perspective on Delivering Emerging Therapies for Patients with BCG-Naïve High-Risk NMIBC.Oncology and therapy · 2025Article
- Heightened IDO1 levels predict Bacillus Calmette-Guèrin failure in high-risk non-muscle-invasive bladder cancer patients.Cell death discovery · 2025Article
- Safety profiles of intravesical Bacillus Calmette-Guerin in bladder cancer.Human vaccines & immunotherapeutics · 2024Article
- Development of a prognostic signature for immune-associated genes in bladder cancer and exploring potential drug findings.International urology and nephrology · 2024Article
- Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.Cancer medicine · 2023Review
- Review
- Bladder cancer immunomodulatory effects of intravesical Nitazoxanide, Rapamycin, Thalidomide and Bacillus Calmette-Guérin (BCG).World journal of urology · 2023Article
- BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer: Current Treatment Landscape and Novel Emerging Molecular Targets.International journal of molecular sciences · 2023Review
- Tuberculosis Epididymo-Orchitis Mimicking Malignancy Resulting from Intravesical Bacillus Calmette-Guérin Immunotherapy for Bladder Cancer: A Case Report of a Rare Complication.Diagnostics (Basel, Switzerland) · 2022Article
- Review
- Immunotherapy in non-muscle-invasive bladder cancer: current status and future directions.World journal of urology · 2021Review
- Round Up.Indian journal of urology : IJU : journal of the Urological Society of IndiaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe conducted the first phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab in patients with high-grade non-muscle-invasive bladder cancer (HGNMIBC) who had persistent or recurrent disease after prior intravesical therapy with BCG. The primary endpoint was the safety of this combination. The secondary endpoint was clinical activity at three months following BCG treatment.
methodsEighteen patients were consented for the study, five of which were screen failures. Six doses of pembrolizumab were administered every 3 weeks over 16 weeks concurrently with six weekly doses of BCG beginning at week 7. Patient safety was evaluated from the time of consent through 30 days following pembrolizumab treatment. Clinical activity was determined using cystoscopy and biopsy of suspicious lesions.
resultsTreatment-related adverse events included one grade 4 adverse event (AEs) (adrenal insufficiency). There were nine grade 3 AEs (chest discomfort, pulmonary embolism, arthritis, wrist edema, injection site reaction, bilateral wrist pain, cardiomyopathy, hypokalemia, urinary tract infection). There were 49 grade 1 and 30 grade 2 AEs (88% of AEs). Eleven patients finished the treatment, and two patients died during the study. Of 13 patients treated, nine patients (69%) had no evidence of disease at 3 months following BCG treatment.
conclusionsWe report for the first time that combining BCG and pembrolizumab in treating HGNMIBC is safe allowing complete treatment of most patients. A phase III trial has opened to test the efficacy of this combination in HGNMIBC (KEYNOTE-676).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.