Clinical trials: Refractory Urothelial Carcinoma
Urothelial Carcinoma, Bladder Cancer
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Upon successful screening and registration, enrollment to a cohort will begin. If DLT criteria are exceeded in a cohort, that cohort will close and will not proceed to Phase 2 of the study.
- Trial name
- ADAPT-BLADDER (NCT03317158)
- Testing
- Durvalumab (Cohort 1-3), External Beam Radiotherapy (EBRT), Bacillus Calmette-Guérin (BCG)
- Where
- 9 sites in United States
- Volunteers
- 186 people
- Sponsor
- Noah Hahn, M.D.
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07342517)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Relmada Therapeutics, Inc.
Bladder Cancer
Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma
The primary objective of this study is to determine in subjects with metastatic measurable bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who have progressed on 1 prior chemotherapeutic…
- Trial name
- NCT01331824
- Testing
- Amrubicin
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Matthew Galsky
Advanced Malignant Neoplasm, Castleman Disease
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body…
- Conditions
- Advanced Malignant Neoplasm, Castleman Disease, Digestive System Carcinoma, Erdheim-Chester Disease
- Trial name
- NCT01552434
- Testing
- Bevacizumab, Cetuximab, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- M.D. Anderson Cancer Center
Triple Negative Breast Cancer, HER2-negative Breast Cancer
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
- Conditions
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer
- Trial name
- NCT06999187
- Testing
- DR-0202
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Dren Bio
Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer
- Trial name
- NCT03538028
- Testing
- INCAGN02385
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Incyte Biosciences International Sàrl
Bladder Cancer
1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back.
- Trial name
- NCT01162785
- Testing
- SCH 721015
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- M.D. Anderson Cancer Center
Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors.
- Conditions
- Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Cancer
- Trial name
- NCT02808143
- Testing
- BCG Solution, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
Bladder Cancer
Ph 1B B-701 in Combination With Pembrolizumab in Metastatic Transitional Cell Carcinoma of the Urothelial Tract
This research study is studying a combination of two experimental drugs as a possible treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder Cancer that got worse while on treatment with…
- Trial name
- NCT02925533
- Testing
- B-701, Pembrolizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mark Pomerantz, MD
Bladder Cancer
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage…
- Trial name
- NCT00003129
- Testing
- valrubicin
- Where
- 10 sites in United States
- Volunteers
- 75 people
- Sponsor
- Eastern Cooperative Oncology Group
Breast Cancer, Urothelial Carcinoma
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.
- Trial name
- NCT03523572
- Testing
- Trastuzumab deruxtecan, Nivolumab
- Where
- 29 sites in United States, Belgium and 5 more
- Volunteers
- 86 people
- Sponsor
- Daiichi Sankyo
Urothelial Cancer
A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma
Background: Metastatic urothelial carcinoma is lethal and has no cure. Response rates to current treatments are modest. Researchers want to find new strategies to treat the disease.
- Trial name
- NCT04501094
- Testing
- Bintrafusp alfa (M7824)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary…
- Trial name
- NCT03945162
- Testing
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Theralase® Technologies Inc.
Bladder Cancer, Urothelial Carcinoma
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4/HER2 CAR-NK cell product in adults with relapsed/refractory locally…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
- Trial name
- DUET-UC-NK (NCT07492628)
- Testing
- EB-DT-NK-UC101, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Beijing Biotech
Metastatic Urothelial Carcinoma, Platinum-Resistant Urothelial Carcinoma
Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer
This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started…
- Conditions
- Metastatic Urothelial Carcinoma, Platinum-Resistant Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8
- Trial name
- NCT04936230
- Testing
- Biospecimen Collection, Bone Scan, Computed Tomography
- Where
- 83 sites in United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Cancer, Metastatic Colorectal Cancer
Study of OB-002 in Patients With Refractory Metastatic Cancer
This is an open-label, non-randomized trial with OB-002 monotherapy dose escalation followed by a dose expansion in patients with metastatic colorectal, pancreatic, gastric, breast, or urothelial cancer who have progressed on two…
- Conditions
- Metastatic Cancer, Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer
- Trial name
- NCT05940844
- Testing
- OB-002
- Sponsor
- Orion Biotechnology Polska Sp. z o.o.
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Trial name
- NCT07725796
- Testing
- UGN-501
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Melanoma, Solid Tumor
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions…
- Conditions
- Melanoma, Solid Tumor, CRAF Gene Amplification, RAF1 Gene Amplification
- Trial name
- NCT04985604
- Testing
- Tovorafenib
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 23 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor…
- Conditions
- Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer, Gastric Cancer
- Trial name
- NCT07227168
- Testing
- STRO-004, Pembrolizumab
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Sutro Biopharma, Inc.