Current Research Studies at TUCC
Bristol Myers Squibb
Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX: CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)
Summary: The purpose of the study is to determine if treating men with castrate-resistant prostate cancer (mCRPC) with nivolumab in combination with docetaxel improves progression-free survival compared to treatment with docetaxel alone.
Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Summary: The purpose of the study is to determine if treatment with apalutamide plus androgen deprivation therapy before and after radical prostatectomy with pelvic lymph node dissection in subjects with high-risk localized or locally advanced prostate cancer is an improvement in pathological complete response rate and metastasis-free survival based on conventional imaging, when compared to placebo plus androgen deprivation therapy.
Title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Summary: The purpose of the study it to determine if the combination of apalutamide and androgen deprivation therapy in participants with high-risk localized prostate cancer improves the Biochemical Recurrence-free rate.
Title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer
Summary: The purpose of the study is to determine the efficacy of treatment with cabozantinib combined with atezolizumab compared to treatment with a second novel hormonal therapy in subjects with metastatic castration resistant prostate cancer.
Title: ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients
Summary: The purpose of this study is to determine if treatment with radium-223 following 16 weeks of enzalutamide or darolutamide treatment in patients demonstrating a biochemical response improves disease outcomes.
Title: A Randomized, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone versus Placebo Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer
Summary: The purpose of the study is to detrmine the efficacy of olaparib+abiraterone combination therapy compared to placebo+abiraterone in patients with metastatic castrate-resistant prostate cancer.
Janssen MAGNITUDE 3001:
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
Summary: The purpose of the study is to determine if niraparib plus abiraterone acetate and prednisone(AA-P) will improve radiographic progression-free survival (rPFS) compared to placebo plus AA-P in subjects with L1 metastatic castrate-resistant prostate cancer (mCRPC) and HRR gene alterations or in subjects with a prespecified subset of HRR gene alterations.
A second purpose of the study is to determine if niraparib plus AA-P will improve rPFS compared to a placebo plus AA-P in subjects with L1 mCRPC with or without HRR gene alterations.
Title: A Phase 1B/2 Open-label Study Evaluating Tazemetostat in Combination with Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naïve Subjects with Metastatic Castration-Resistant Prostate Cancer
Summary: The purpose of the Phase 2 study is to determine the benefit of combining tazemetostat with enzalutamide compared to enzalutamide alone in length of radiographic progression-free survival (rPFS) according to Prostate Cancer Clinical Trials Working Group 3 criteria for progression in bone or in soft tissue.
Title: PROCADE: A Multinational, Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Summary: The purpose of this study is to determine the efficacy of the study drug, HC-1119, for overall response rate and as compared to enzalutamide for achieving a ≥ 50% decline in PSA50.
Title: A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of Talazoparib in Combination with Physician’s choice of Enzalutamide or Abiraterone Acetate/Prednisone in Metastatic Castration-resistant Prostate Cancer with DNA Damage Repair Deficiencies
Summary: The purpose of the study is to confirm that 1mg per day as the starting dose of talazoparib for each treatment combination during Part 2 (double-blind treatment period. A second purpose of the study is to characterize talazoparib and Novel Hormone Therapy pharmacokinetics when dosed in combination.
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Summary: The purpose of the study is to determine if niraparib, abiraterone acetate and prednisone improves radiologic progression free survival in participants with deleterious germline or somatic HRR gene-mutated metastatic castration-sensitive prostate cancer.
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Active, recruiting new patients The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC With Deoxyribonucleic Acid (DNA) Damage Repair Deficiencies (DDR)
Active, recruiting new patients This study compares rPFS in men with DDR deficiency(ies) mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Patients Undergoing TURBT
Active, recruiting new patients This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to intermediate risk tumor characteristics will be included in the study.
Title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Summary: The purpose of the study is to determine if treatment with infigratinib improves disease-free survival (DFS) compared with placebo treatment in subjects with invasive urothelial carcinoma with susceptible FGFR3 alterations after nephroureterectomy, distal ureterectomy, or cystectomy
Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Summary: The purpose of the study is to determine if treatment with erdafitinib reduces tumor recurrence compared to intravesical chemotherapies in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who also have FGFR mutations or fusion whose cancer has recurred after Bacillus Calmette-Guerin (BCG) therapy.
Title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy
Summary: The purpose of the study is to compare the overall response to treatment between 3 different treatments: 1) participants treated with the investigational device TAR-200/gemcitabine in combination with cetrelimab, or 2) participants treated with TAR-200/gemcitabine alone or 3) cetrelimab alone. The study will include patients with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.
Title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination with Cetrelimab Versus Concurrent Chemoradiotherapy in Participants with Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy
Summary: The purpose of the study is to compare bladder intact event-free survival between participants receiving TAR-200 in combination with cetrelimab and participants receiving chemotherapy and radiation treatment.
Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guerin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Summary: The purpose of the study is to compare the rate of recurrence free survival between treatment with erdafitinib compared to Investigator’s Choice of treatment for participants with high-risk NMIBC who harbor FGFR mutations or fusions, and who recurred after Bacillus Calmette-Guerin therapy.
Title: Phase I Safety and Tolerability of Intravesical VAX014 for Instillation in Subjects with Non-Muscle Invasive Bladder Cancer (NMIBC)
Summary: The purpose of the study is to determine the maximum tolerated dose (MTD) [or maximum practical dose (MPD)] of intravesical VAX014 and to determine the safety profile of intravesical VAX014.