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Showing 1 - 10 of 38 Trials

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High-Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Principal Investigator:

Andrew T Lenis, MD

Contact Number:

212-342-5162

NCT Number:

NCT05538663

Population:

Adult

Phase:

III

This study is being done to answer the following question: Can we lower the chance of your bladder cancer growing or spreading by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual therapy? The usual approach for patients who are not in a study is treatment with Transurethral surgery of bladder tumor (TURBT) followed by instillations of Bacillus Calmette-Guerin (BCG) immunotherapy into the bladder via a catheter. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your bladder...
A Phase III Randomized, Open-Label, Multicenter Study 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

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT04960709

Population:

Adult

Phase:

III

The purpose of this study is to learn more about if the combination of medications not approved by the Food and Drug Administration (FDA), called durvalumab, tremelimumab and enfortumab vedotin (EV) given intravenously before and after surgery will work and be safe to treat muscle invasive bladder cancer (This is a cancer that spreads into the detrusor muscle of the bladder. The detrusor muscle is the thick muscle deep in the bladder wall) in patients not eligible or who do not want to receive a type of platinum containing chemotherapy (cisplatin), and also to better understand the studied...
A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06534983

Population:

Adult

Phase:

II

This study is testing a drug called autogene cevumeran in combination with nivolumab, a cancer treatment drug known for treating bladder cancer. The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus nivolumab versus nivolumab on patients with Muscle Invasive Urothelial Carcinoma (MIUC.) In this study, you will get either autogene cevumeran plus nivolumab or saline plus nivolumab. Autogene Cevumeran is not approved by the Food and Drug Administration to treat muscle-invasive urothelial cancer. Are you Eligible? (Inclusion Criteria) 18 years or older - For...
A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06225596

Population:

Adult

Phase:

II/III

The purpose of this study aims to determine if BT8009, when given in combination with pembrolizumab, works against urothelial cancer. This will be compared to standard chemotherapy treatment followed by avelumab therapy. This research study also aims to understand the side effects of BT8009 when given in combination with pembrolizumab. The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Food and Drug Administration (FDA) to treat a certain condition or illness or a certain type of patient. Pembrolizumab is an antibody...
A Phase 1a/1b Study of LY4052031, an Antibody-Drug ConjugateTargeting Nectin-4, in Participants with Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06465069

Population:

Adult

Phase:

I

The purpose of this study is to determine whether using LY4052031 in a type of cancer that may have tumor cells that express a protein called Nectin-4 is safe and how well the cancer responds to the study drug. LY4052031 has not been approved by the US Food and Drug Administration (FDA). This is a first in human study and all of the risks are not fully known yet. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Life expectancy must be more than 12 weeks - Must not have uncontrolled diabetes
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...
An Open-Label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, inAdvanced Solid Tumor Malignancies with SMARCA4/BRG1 Alterations- J5M-OX-JOXA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06561685

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an investigational treatment called LY4050784 in subjects with solid tumors that have a particular genetic abnormality (called an alteration or mutation) of a gene called SMARCA4 and/or BRG1. LY4050784 is an investigational (or experimental) drug, taken by mouth that targets a gene called SMARCA2/BRM, and may treat certain cancers. Investigational means neither the FDA nor any other health or regulatory authority in other countries have approved LY4050784. This study will be the first time LY4050784 will be tested in humans. Are you Eligible...
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05176483

Population:

Adult

Phase:

I

The purpose of this study is to evaluate the efficacy of the study drug, XL092 alone and/or in combination of other study drugs such as with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed dose combination as a potential anticancer therapy to treat people with locally advanced or metastatic cancers including advanced renal cell cancer, castration-resistant prostate cancer, bladder cancer, liver cancer, lung cancer, colon cancer, head and neck cancer. Nivolumab has been approved as single agent for the treatment of melanoma, lung cancer, and bladder cancer and in...
A Phase 1 Open-Label Study of PF-07985045 as a Single-Agent and in Combination with Other Anti-Cancer Agents in Participants with Advanced Solid Tumors

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06704724

Population:

Adult

Phase:

I

The purposes of this research study are (1) to learn about the safety and the effects of study drug, PF-07985045 on your specific cancer and on your body, with or without combination drugs and (2) to find the best dose for treating your specific type of cancer, as well as treating other types of cancers. This study is divided in two parts: Part 1 and Part 2. Part 1 testing and results applies to the study drug alone, called monotherapy. The goal of Part 1 is to determine the maximum tolerated dose (highest dose that is safe and tolerable in study participants, called MTDM and the recommended...
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP6306 Alone or in Combination with RP-3500 or Debio 0123 in Patients with Advanced Solid Tumors (MYTHIC Study)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04855656

Population:

Adult

Phase:

I

The purpose of this research study is to test how safe RP-6306 is at different doses and schedules, test how well RP-6306 works to shrink cancer in the body, and evaluate if food affects the way RP-6306 moves through your body. This study will test the investigational drug, RP-6306, for the first time in humans. “Investigational” means that the study drug being tested has not been approved by the United States Food and Drug Administration (FDA). RP- 6306 is a PKMYT1 inhibitor (blocks the activity of the PKMYT1 protein) that is designed to stop certain cancer cells from growing...

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