Clinical Trial Search Results

Filter Results

Age group

Category

Primary purpose

Study type

Location

Search results

You can use the filters to refine your search.

Displaying 1 - 13 of 13

Open Actively Recruiting

CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Phase: N/A
Gender: All
Age Group: Adults
Contact: KRISTEN WILLIAMS
Investigator: Karim Chamie, MD
Open Actively Recruiting

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

This study is directed to patients with Non-Muscle Invasive Bladder Cancer (NMIBC) that have not previously been treated with Bacillus Calmette-Guerin (BCG). The purpose of this research study is to find out what are the side effects of the study drug, ALT-803, plus BCG in NMIBC. The study drug, ALT-803 is given through intravesical therapy, which means the drug is given directly into the bladder (through a catheter). In this study, investigators wish to find out how safe the study drug is and how well it is tolerated. They also wish to find out if the study drug plus BCG can stop the growth of the tumor. The team also wants to collect some other information about the study drug that will help improve the way the study drug is given to patients. ALT-803 will be tested with BCG. ALT-803 is investigational drug, which means that it has not been approved by the United States Food and Drug Administration (FDA), but the FDA has given its permission for ALT-803 to be tested in this research study.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Nazy Zomorodian
Investigator: Karim Chamie, MD
Open Actively Recruiting

Genetic and Gene Expression Profiling of Small Cell Carcinoma of the Bladder

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Arnold Chin
Open Actively Recruiting

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: KATHRYN B HILBURN
Open Actively Recruiting

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Jamaica, Nigeria, Norway, Spain, Sweden, Switzerland, the United Kingdom (UK), and the US. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.

Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Phase: N/A
Gender: Male
Age Group: Adults
Contact: Nazy Zomorodian
Open Actively Recruiting

Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

Phase: Phase I
Primary Purpose: Basic Science
Gender: All
Age Group: Adults
Contact: JEREMIE CALAIS
Open Actively Recruiting

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Nazy Zomorodian
Investigator: Karim Chamie, MD
Open Actively Recruiting

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

The purpose of this research study is to find out if the study drug, ALT-803, plus BCG can stop the growth of tumor in patients with non-muscle invasive bladder cancer whose tumor persisted after treatment with BCG. The sponsor also wish to collect some other information that will help them to improve the way study drug is given to patients.

In this research study, ALT-803 will be tested with BCG.

Patient will have a complete physical exam and vital signs including height, weight, heart and breathing rate, blood pressure and temperature will be checked. About two teaspoons of blood will be collected for testing the functions of patient's kidneys, liver and other organs and for blood cell counts. We will also collect urine for routine urine tests. An electrocardiogram (EKG) will be run to test electrical activity of patient's heart. The patient's lung functions will be examined if it is indicated, and will need to have a biopsy of patient's tumor tissue within 6 weeks of study entry to check the status of the disease. We also need to collect some tissue from these biopsies. The tissue may be analyzed for genes, gene products, proteins, or makers involved in cancer, interleukin response or cell death. The tissue from patient's biopsies that are collected for testing will be analyzed and stored for possible future analysis. Results from these screening tests will be used by the study doctor to find out if the patient qualifies for the research study. If the patient is a woman who can have children, we will collect another teaspoon of blood for a pregnancy test. The study doctor or study staff will tell the patient if the pregnancy test results are positive. The results of the pregnancy test must be negative in order for you to be in the study. We will enroll the patient and schedule their visits to receive the study treatment within 14 days. If the screening tests show that the patient is not eligible to continue in the research study, then the patient may not take part.

Patient's participation in the study will include one cycle of study treatment consisting of six weekly doses of BCG plus ALT-803 study drug and every 3 months visits to evaluate their response to the study treatment. Participants will receive 4 cycles of 3 weekly doses of BCG plus ALT-803 every 3 months if there is no tumor growth. Participants will receive another cycle of study treatment consisting of six weekly doses of BCG plus ALT-803 if there is a decrease in amount of cancer (residual tumor) at 3 months, followed by 4 cycles of 3 weekly doses of BCG plus ALT-803 every 3 months if there is no tumor growth in follow ups. If there is no decrease in the amount of cancer in after one cycle of treatment (6 weeks), patients will not receive more doses of study treatment.

Patient will be closely monitored during the entire treatment period. This study will last as long as patient does not have unacceptable side effects. After the patient completes the study treatment period, if they received at least one dose of study treatment, we will continue to monitor and follow the patients disease and health status every 3 months during years 1 and 2 by scheduled office visits

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Nazy Zomorodian
Investigator: Karim Chamie, MD
Open Actively Recruiting

Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer

This phase I trial studies the side effects and best dose of navtemadlin in treating patients with glioblastoma (brain cancer) that is newly diagnosed or has come back (recurrent). Navtemadlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: QUAN LI
Open Actively Recruiting

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). The purpose of this study is to compare the effects, good or bad, of the atezolizumab combination versus standard treatment with atezolizumab on patients with bladder cancer, to find out which is better. We expect to enroll approximately 5 people at UCLA and 130-305 (stage 1) & 30-80 (stage 2) patients study wide.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)

This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A, either alone or in combination with a check point inhibitor, in patients with advanced or metastatic epithelial tumours.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CHRISTOPHER LIM
Investigator: Lee S. Rosen, MD
Open Actively Recruiting

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts.

The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Investigator: Aaron Lisberg, MD