Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study
NCT03832673 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-02-26
Summary
An open label, monocenter, single-arm, phase 2 study of neoadjuvant pembrolizumab and epacadostat, preceding radical cystectomy, for patients with muscle-invasive bladder cancer.
Conditions
- Muscle-invasive Bladder Cancer
Interventions
- DRUG
-
Pembrolizumab 200 mg IV every 3 weeks (for 3 cycles)
- DRUG
-
Epacadostat
Epacadostat 300 mg (BID) orally continuously every 28 days (for 3 cycles)
Sponsors & Collaborators
-
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
lead OTHER
Principal Investigators
-
Andrea Necchi, MD · Fondazione IRCCS Istituto Nazionale Tumori-Milano
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-22
- Primary Completion
- 2019-05-22
- Completion
- 2019-05-22
Countries
- Italy
Study Locations
More Related Trials
-
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
NCT02625961 ·Status: COMPLETED ·Phase: PHASE2
-
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
NCT03244384 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
NCT03532451 ·Status: COMPLETED ·Phase: PHASE1
-
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
NCT03978624 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
NCT06305767 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma
NCT03534804 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer
NCT02662062 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
NCT04164082 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
NCT03319745 ·Status: COMPLETED ·Phase: PHASE2
-
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
NCT03924856 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Investigator Grant (IG) 2022 27746
NCT06341478 ·Status: RECRUITING ·Phase: NA
-
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
NCT04586244 ·Status: TERMINATED ·Phase: PHASE2
-
Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects
NCT02365766 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer
NCT02560636 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer
NCT02808143 ·Status: COMPLETED ·Phase: PHASE1
-
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
NCT05687721 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer
NCT05535218 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma
NCT03287050 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
NCT02853305 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
NCT02621151 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer
NCT03272217 ·Status: TERMINATED ·Phase: PHASE2
-
Drug Screening Using IMD in Bladder Cancer
NCT06204614 ·Status: ENROLLING_BY_INVITATION ·Phase: EARLY_PHASE1
-
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
NCT04209114 ·Status: COMPLETED ·Phase: PHASE3
-
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
NCT03924895 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pembrolizumab in Muscle-invasive Bladder Cancer
NCT05406713 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2