Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Ureteral Neoplasms

Urethral Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ureteral Diseases

Urethral Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

TOCOSOL Paclitaxel

Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium

Achieve Life Sciences

Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Crizotinib was administered orally at 250mg twice daily

Earle Burgess, MD

This is a single arm two-stage phase II study with crizotinib (Xalkori®) in the treatment of subjects with metastatic urothelial cancer of the bladder, upper (ureter or renal pelvis) or lower (urethra) urinary tracts. The purpose of this study is to see if this experimental drug has a potential benefit in subjects with stage 4 urothelial cancer.

This study tests crizotinib used alone in subjects with urothelial cancer, previously treated with chemotherapy, and whose tumors have certain proteins. Proteins are complex natural substances essential to the structure and function of all living cells. These proteins, c-MET or RON, may trigger molecular pathways that are involved in the growth and spread of bladder or upper urinary tract cancer. Crizotinib is a drug taken by mouth that blocks these pathways. Early laboratory research suggests that crizotinib may benefit patients with urothelial and other cancers with these molecular pathways.

This is a single arm two-stage phase II study designed to evaluate the objective response rate in subjects with metastatic urothelial cancer demonstrating c-MET or RON overexpression who have received prior therapy with a cisplatin or carboplatin containing regimen.

Subjects will be recruited at Levine Cancer Institute (LCI) and other participating sites.

Immunohistochemistry will be utilized to define tumor sample c-MET and RON protein expression patterns for assignment into molecular cohorts as described in section 12.1.

In the first stage of this study, subjects will be enrolled in parallel to three molecularly defined cohorts as follows:

1. c-MET high (\>50%), RON null (0-9%) (n = 14 subjects)
2. c-MET-positive (10-100%), RON-positive (10-100%) (n = 7 subjects)
3. c-MET null (0-9%), RON-positive (10-100%) (n = 7 subjects)

All enrolled subjects will continue with study treatment until criteria for treatment discontinuation has been met.

If Stage 1 response criteria are met in a cohort, the cohort may be considered for expansion, and additional subjects (16 in Cohort 1 or 25 in Cohorts 2 or 3) may then be enrolled into that cohort in Stage 2. An expansion cohort will be defined by the Sponsor- Investigator following review of all available trial data which will be conducted after the first Stage 1 cohort has completed accrual and at least every six months thereafter until all Stage 1 cohorts have completed accrual.

If more than one cohort meets Stage 1 response criteria (2 responses out of 14 subjects for Cohort 1 or 1 response out of 7 subjects for each of Cohorts 2 and 3), then the cohort showing the highest response rate will be given highest consideration for expansion.

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer

LCI-GU-URO-CRI-001: A Phase II Study of Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer

Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is required.

Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.

PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.

Pfizer

Wake Forest University Health Sciences

Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.

c-MET high (\> 50%), RON null (0-9%)

Crizotinib: All arms will receive crizotinib.

Cohort 1

c-MET + (10-100%), RON + (10-100%)

Crizotinib: All arms will receive crizotinib.

Cohort 2

c-MET null (0-9%), RON + (10-100%)

Crizotinib: All arms will receive crizotinib.

Cohort 3

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Primary Tumor Site

Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group, where 0 indicates subject is fully active, able to carry on all pre-disease performance without restriction and where 1 indicates subject is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

ECOG at Baseline

c-MET protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.

c-MET Expression, %

RON protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.

RON Expression, %

Note, there were no subjects enrolled to cohort 2 as no subjects were enrolled who were c-MET + and RON+. Therefore, no baseline results are available for Cohort 2.

Chair of Biostatistics Department

This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.

Total Enrolled Study Cohort

Study was designed to evaluate objective response rate overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline.

Overall Response

Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.

Overall Survival

Progression Free Survival

c-MET + (10-100%), RON + (10-100%)

Crizotinib was administered orally at 250 mg twice daily.

c-MET null (0-9%), RON + (10-100%)

Crizotinib was administered orally at 250 mg twice daily.

Overall Study

scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy

scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy

Lymphadenectomy (intervention group only):

Lymphadenectomy performs in four fractions on the right side and two fractions on the left side according to Dissection template (Appendix 1). Renal hilar nodes are included in fraction 1 and 3, respectively.

Lymphadenectomy in conjugation with nephroureterectomy

Removing the kidney, ureter and bladder cuff

Nephroureterectomy without lymphadenectomy

Nessn H Azawi, MB.Ch.B.

Two out of three tumours in the upper urinary tract are located in the renal pelvis. Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive disease. Information regarding indications, extent and possible curative potential is currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with survival data for patients with lymph node metastasis that report long term survival after surgery as monotherapy \[4\] with similar survival proportions as in bladder cancer with lymph node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to the only available prospective study, where 68 patients with UUTUC were submitted to template-based lymphadenectomy. Another retrospective study by the same Japanese group, showed that 5-year cancer-specific and recurrence-free survival was significantly higher in the complete lymphadenectomy group than in the incomplete lymphadenectomy or without lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.

Background:

Two out of three tumours in the upper urinary tract are located in the renal pelvis. Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive disease. Information regarding indications, extent and possible curative potential is currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with survival data for patients with lymph node metastasis that report long term survival after surgery as monotherapy with similar survival proportions as in bladder cancer with lymph node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to the only available prospective study, where 68 patients with UUTUC were submitted to template-based lymphadenectomy. Another retrospective study by the same Japanese group, showed that 5-year cancer-specific and recurrence-free survival was significantly higher in the complete lymphadenectomy group than in the incomplete lymphadenectomy or without lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.

Hypothesis: Complete lymphadenectomy during nephroureterectomy because of invasive urothelial carcinoma may reduce the incidence of lymph nodes metastasis, local recurrence, distant metastasis and improve the cancer survival rate.

Purpose: To evaluate the influence of complete lymphadenectomy on recurrence and cancer specific survival rate compared to limited or no lymphadenectomy.

Primary endpoint/analysis: Recurrence free survival at five-year postoperative. Secondary endpoints: Incidence of lymph node metastases, local recurrence and/or distant metastasis, cancer specific and overall survival at one, three and five-year postoperative. Complications rate according to Clavien classification within the first thirty days postoperatively.

Another endpoint/analysis: Multivariate analysis of possible preoperative risk factors for lymph node metastases (tumour size, preoperative urinary cytology, lymph node enlargement on CT, PET-CT positivity) and postoperative risk factors for lymph node metastases (stage, grade, tumour diameter, presence of necrosis in the tumour (none; \<10%; \>10% of total tumour area), number of lymph nodes excised).

Design: Prospectively randomized to template based lymphadenectomy or not, in patients with clinically muscle-invasive UUTUC in the renal pelvis or upper 2/3 of the ureter. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 183 patients in each group. Group A will be scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy except for clinically enlarged. Group B will be scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy.

Lymphadenectomy in Urothelial Carcinoma

Lymphadenectomy in Urothelial Carcinoma in the Renal Pelvis and Ureter

Zealand University Hospital

Urologist

Pembrolizumab

Avelumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Copanlisib will be administered through intravenous infusion (IV) at 60 mg on Day 1, 8 and 15, and avelumab will be administered 800 mg IV on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles

intravenous infusion (IV) at 60 mg on Day 1, 8 and 15 of each 4-week treatment cycle for up to 26 cycles

copanlisib

800 mg intravenous infusion on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles

Chong-Xian Pan, MD PhD

Hizra Farrukh, MD

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Patients with advanced urothelial cancer will be treated with platinum-based chemotherapy. After chemotherapy, an imaging study will be performed to determine cancer response. If there is no disease progression, patients will be eligible for this study. After informed consent is obtained, patients are enrolled. The treatment include immunotherapy avelumab as the standard of care plus a study medication copanlisib. Both medications are administrated through intravenous infusion. Avelumab wil be given once every two weeks while copanlisib will be administrated on Day 1, 8 and 15 of every 4-week cycle. Patient will be followed up for disease progression.

Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

A Phase II Trial With Copanlisib Plus Avelumab as a Maintenance Therapy for Metastatic Bladder Cancer After Platinum-based Chemotherapy

Immune cell infiltration, immune cell activation/exhaustion status, cytokine production and signaling transduction pathways will be studied.

The primary endpoint is PFS. PFS is defined as the time between initiation of the avelumab/copanlisib combination and tumor progression or death from any cause, with censoring of patients who are lost to follow-up.

Overall survival is defined as the length of time from the start of this trial treatment to the time of death from any cause

Objective response rate is defined as the percentage of patients who have a partial or complete response at any time during this treatment of this trial

Disease-control rate is defined as the percentage of patients who have a partial or complete response or stable disease at any time during this treatment of this trial

Adverse events are defined as any untoward medical occurrence of subjects which does not necessarily have a causal relationship with the treatment

Bayer

VA Office of Research and Development

Pelvic Neoplasms

Gemcitabine

Carboplatin

Antibodies

Cisplatin

Immunoglobulins

Antimetabolites

Immune Checkpoint Inhibitors

Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days

Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days

Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days

Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days

Enfortumab vedotin on days 1 and 8 every 21 days

Enfortumab vedotin on days 1 and 8 and every 21 days

Intravenous (IV) infusion on days 1 and 8 every 21 days

enfortumab vedotin (EV)

pembrolizumab

cisplatin

carboplatin

IV infusion on days 1 and 8 every 21 days

gemcitabine

Changting Meng, MD

Jason Lukas, MD, PhD

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts:

Locally advanced or metastatic urothelial cancer:

* Dose escalation
* Expansion

  * Part 1: Cohorts A and Optional B
  * Part 2: Cohorts D, E, and Optional F
  * Part 3: Cohort G.
* Randomized Cohort K

  * EV Monotherapy Arm
  * EV Combination Arm

Muscle invasive bladder cancer:

* Cohort H
* Optional Cohort J
* Cohort L

multi-cohort, open-label, multicenter study, global

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

Descriptive statistics will be used to summarize results.

The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1

The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.

Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).

The proportion of patients with confirmed CR or PR according to RECIST 1.1.

The proportion of patients with confirmed CR or PR according to RECIST 1.1

The proportion of patients with confirmed CR or PR according to iRECIST.

Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.

Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1

Proportion of patients with CR, PR, or SD according to iRECIST.

The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD per RECIST 1.1) or to death due to any cause, whichever comes first.

The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per RECIST 1.1 or to death due to any cause, whichever comes first

The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per iRECIST or to death due to any cause, whichever comes first.

The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first.

The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first

The time from start of study treatment to first documentation of objective tumor progression (PD per iRECIST) on or following study therapy, or to death due to any cause, whichever comes first.

The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.

The time from start of study treatment to date of death due to any cause.

Cmax will be derived from the PK blood samples collected.

Blood samples for ATA analysis will be collected.

Tmax will be derived from the PK blood samples collected.

AUC will be derived from the PK blood samples collected.

The pDS rate is defined as patients with tumors \<pT2 and N0 in examined tissue from radical cystectomy (RC) and pelvic lymph node dissection (PLND).

DFS is defined as the time from RC to the time of first occurrence of a DFS event, including local recurrence of urothelial cancer (UC), urinary tract recurrence of UC, distant metastasis of UC, or death from any cause.

DFS is defined as the time from RC to the time of first occurrence of a DFS event

Delayed is defined as greater than 12 weeks after the last dose of treatment.

Merck Sharp & Dohme LLC

Seagen Inc.

Astellas Pharma Global Development, Inc.

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

LOXO-435 administered orally to participants with FGFR3-altered advanced solid tumors.

LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma. (Cohort to be implemented as needed, based on Sponsor's discretion.)

LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma who were previously treated with an FGFR inhibitor.

LOXO-435 administered orally to participants with FGFR3-altered advanced urothelial carcinoma who have not received a prior FGFR inhibitor.

LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV) to participants with FGFR3-altered advanced urothelial carcinoma who have not received a prior FGFR inhibitor.

LOXO-435 administered orally to participants with advanced solid tumors who have not received a prior FGFR inhibitor.

LOXO-435

Patient Advocacy

Ryan Widau, PhD

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

This is an open-label, multi-center, phase 1a/b study in participants with FGFR3-altered advanced solid tumors, including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Dose escalation and dose optimization (1a) and dose expansion (1b). Phase 1a will include up to 2 cohorts to assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D) (or optimal dose). Phase 1b will include 4 dose expansion cohorts of participants with prespecified activating FGFR3 alterations to evaluate the efficacy and safety of LOXO-435 at the RP2D. Cohort B will enroll pts with metastatic UC and includes three cohorts to evaluate LOXO-435 as monotherapy (B1, B2) and in combination with pembrolizumab (B3). Cohort C will enroll pts with non-UC advanced solid tumors and includes a cohort to evaluate LOXO-435 as monotherapy (C1).

A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3

An Open-Label, Multicenter Study of LOXO-435 (LY3866288) In Advanced Solid Tumor Malignancies With FGFR3 Alterations

ORR per investigator assessed RECIST v1.1

The BlCS has 12 items with a total score range of 0 to 48, with higher scores representing better bladder-related symptoms. A ≥ 4-point score change from baseline will be considered as clinically meaningful improvement in bladder-related symptoms

The PWB subscale has 7 items with a total score range of 0-28, with higher scores representing better physical function. A ≥ 3-point score change from baseline for a participant will be considered as clinically meaningful improvement in physical function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium	NCT00077688	Bladder Neoplas... Ureteral Neopla... Urethral Neopla... Carcinoma, Tran...	TOCOSOL Paclita...	18 Years -	Achieve Life Sciences
LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer	NCT02612194	Urinary Bladder... Ureteral Neopla... Urethral Neopla...	Crizotinib	18 Years -	Wake Forest University Health Sciences
Lymphadenectomy in Urothelial Carcinoma	NCT02607709	Ureteral Neopla...	Lymphadenectomy... Nephroureterect...	18 Years -	Zealand University Hospital
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer	NCT05687721	Advanced Urothe...	copanlisib Avelumab	18 Years -	VA Office of Research and Development
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer	NCT03288545	Carcinoma, Tran... Urinary Bladder... Urologic Neopla... Renal Pelvis Ne... Urothelial Canc... Ureteral Neopla... Urethral Neopla...	enfortumab vedo... pembrolizumab cisplatin carboplatin gemcitabine	18 Years -	Astellas Pharma Inc
A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3	NCT05614739	Urinary Bladder... Neoplasm Metast... Ureteral Neopla...	LOXO-435 Pembrolizumab	18 Years -	Eli Lilly and Company
LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer	NCT02612194	Urinary Bladder... Ureteral Neopla... Urethral Neopla...	Crizotinib	18 Years -	Wake Forest University Health Sciences
A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3	NCT05614739	Urinary Bladder... Neoplasm Metast... Ureteral Neopla...	LOXO-435 Pembrolizumab	18 Years -	Eli Lilly and Company
TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma	NCT01328574	Urothelial Carc... Ureteral Neopla... Ureter Cancer Neoplasm, Urete... Cancer of the U...	TRC105	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for ureteral neoplasms