Cancer

Clinical Research Studies in Cancer

Bladder Cancer

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Principal Investigator: JJ Zhang, MD
Status: Enrolling

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: Huong Pham, MD
Status: Enrolling

 

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A phase 2, randomised, multi-centre, open label trial to evaluate safety & efficacy of intravesical nadofaragene firadenovec alone or in combo with chemo (gem & doce) or immunotherapy (pembro) in high-grade BCG unresponsive NMIBC
Principal Investigator: JJ Zhang, MD
Status: Not Yet Enrolling

MODERN: AN INTEGRATED PHASE 2/3 AND PHASE 3 TRIAL OF MRD-BASED OPTIMIZATION OF ADJUVANT THERAPY IN UROTHELIAL CANCER
Principal Investigator: Huong Pham, MD
Status: Not Yet Enrolling

 

Blood Cancer

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
Principal Investigator: David Aboulafia, MD
Status: Not Yet Enrolling

 

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A Randomized, Open-label, Phase 3 Trial of A+AVD versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

 

Brain Cancer

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms Short Title:  STaRT
Principal Investigator: Huong Pham, MD
Status: Enrolling

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.
Principal Investigator: Huong Pham, MD
Status: Enrolling

Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in MGMT+ GBM
Principal Investigator: John Paul Flores, MD 
Status: Enrolling

 

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Randomized trial of veliparib or placebo in combination with adjuvant temozolomide in newly diagnosed GBM with MGMT promoter hypermethylation
Principal Investigator: John Paul Flores, MD
Status: Closed to Enrollment

Breast Cancer

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
Principal Investigator: Nanette Robinson, MD
Status: Enrolling

NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemo to Ovarian Function Suppression + Endocrine Therapy in Premenopausal Patients w/ pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)
Principal Investigator: Huong Pham, MD
Status: Enrolling

 

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A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A PHASE III CLINICAL TRIAL COMPARING TRASTUZUMAB GIVEN CONCURRENTLY WITH RADIATION THERAPY AND RADIATION THERAPY ALONE FOR WOMEN WITH HER2-POSITIVE DUCTICAL CARCINOMA IN SITU RESECTED BY LUMPECTOMY
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A RANDOMIZED, PHASE III TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MK-3475 (PEMBROLIZUMAB) AS ADJUVANT THERAPY FOR TRIPLE RECEPTOR-NEGATIVE BREAST CANCER WITH ≥ 1 CM RESIDUAL INVASIVE CANCER OR POSITIVE LYMPH NODES (ypN+) AFTER NEOADJUVANT CHEMOTHERAPY
Principal Investigator: Meaghan O'Malley, MD
Status: Closed to Enrollment

Intra-Operative Radiotherapy after breast conserving therapy in the treatment of early stage breast cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk Hormone Receptor-Positive and Her2/Neu Negative Breast Cancer
Principal Investigator: Nanette Robinson, MD
Status: Closed to Enrollment

Cancer Non-Specific

EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III TrialEA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial
Principal Investigator: Bruce Lin, MD
Status: Enrolling

Virginia Mason Medical Center and Benaroya Research Institute Tumor Tissue Repository (VM-BRITE) Sample Collection Protocol
Principal Investigator: Christopher Gault, MD 
Status: Enrolling

 

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A prospective observational cohort study to assess miRNA 371 for outcome prediction in patients with newly diagnosed germ cell tumors
Principal Investigator: John Paul Flores, MD
Status: Closed to Enrollment

Characterization of the peripheral blood signature in patients treated with PD1/PDL-1 Checkpoint Inhibitors
Principal Investigator: John Paul Flores, MD
Status: Closed to Enrollment

Phase III Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Program for the assessment of clinical cancer tests (PACCT-1):  Trial assigning individualized options for treatment:  The TAILORx Trial
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Colorectal Cancer

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A PHASE 3 RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY, EXCISION AND OBSERVATION VERSUS CHEMORADIOTHERAPY FOR EARLY RECTAL CANCER
Principal Investigator: Huong Pham, MD
Status: Enrolling

HAI Consortium Research Network: Registry of Hepatic Arterial Infusion (HAI)
Principal Investigator: Lauren Wancata, MD
Status: Enrolling

The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients with Locally Advanced Rectal Cancer
Principal Investigator: Val Simianu, MD
Status: Enrolling

 

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A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III –Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Randomized trial of standard chemotherapy alone or combined with Atezolizumab as adjuvant therapy for patients with Stage III colon cancer and deficient DNA mismatch repair.
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

NEOADJUVANT CHEMOTHERAPY, EXCISION AND OBSERVATION FOR EARLY RECTAL CANCER | The NEO Trial.
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

 

Gastroesophageal Cancer

A Phase 2 Study of Futibatinib in Combination with PD-1 Antibody-based Standard of Care Therapy in Patients with Solid Tumors
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Phase 2 study of ZW25 plus first-line combination chemotherapy in HER2-Expression gastroesophageal adenocarcinoma (GEA)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

 

Gynecologic Cancer

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)
Principal Investigator: Allison Barrie, MD
Status: Enrolling

Hepatobiliary Cancer (Liver and Biliary Tract)

A PHASE 1 DOSE ESCALATION AND COHORT EXPANSION STUDY OF TSR-022, AN ANTI-TIM-3 MONOCLONAL ANTIBODY, IN PATIENTS WITH ADVANCED SOLID TUMORS (AMBER)
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A PHASE II, OPEN-LABEL, MULTI-COHORT, MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
Principal Investigator: Bruce Lin, MD
Status: Enrolling

ALTUS: PERFORMANCE OF A MULTI-TARGET HEPATOCELLULAR CARCINOMA (HCC) TEST IN SUBJECTS WITH INCREASED RISK
Principal Investigator: Asma Siddique, MD
Status: Enrolling

 

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A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY 4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy Regimen
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement (FIGHT-302)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Single Arm Phase Ib/II Multi-Center Study of Nivolumab in Combination with nanoliposomal-Irinotecan, 5-Fluorouracil, and Leucovorin as Second Line Therapy for Patients with Advanced Biliary Tract Cancer
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

 

HIV/AIDS Malignancies

Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living with HIV: A Feasibility Study
Principal Investigator: David Aboulafia, MD
Status: Enrolling

 

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A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

ANCHOR: Anal Cancer/HSIL Outcomes Research Study
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

 

Kaposi Sarcoma

A Phase 2 Trial of Ixazomib for Kaposi Sarcoma
Principal Investigator: David Aboulafia, MD
Status: Enrolling

Multicenter Phase II Study of Pomalidomide Monotherapy in Kaposi Sarcoma
Principal Investigator: David Aboulafia, MD
Status: Enrolling

 

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A Phase II Study of sEphB4-HAS in Kaposi Sarcoma
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

A Pilot Study of Nelfinavir for the Treatment of Kaposi Sarcoma: A Trial of the AIDS Malignancy Consortium (AMC)
Principal Investigator: David Aboulafia, MD
Status: Closed to Enrollment

Kidney Cancer

NRG-GU012: RANDOMIZED PHASE II STEREOTACTIC ABLATIVE RADIATION THERAPY (SABR) FOR METASTATIC UNRESECTED RENAL CELL CARCINOMA (RCC) RECEIVING IMMUNOTHERAPY (SAMURAI)
Principal Investigator: Huong Pham, MD
Status: Enrolling

 

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EVEREST EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Neuroendocrine Tumors

An International, Non-Interventional, Post-Authorization Long-Term Safety Study of Lutathera®, in Patients with Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours (SALUS study).
Principal Investigator: Bruce Lin, MD
Status: Enrolling

 

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Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on everolimus (CABINET)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Pancreatic Cancer

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination with Chemotherapy (mFOLFIRINOX) in Participants with CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination with Avutometinib (VS-6766) and Defactinib in Patients with Previously Untreated Metastatic Adenocarcinoma of the Pancreas
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy with Lumen-Apposing Metal Stent for Gastric Outlet Obstruction from Malignant Unresectable Disease
Principal Investigator: Shayan Irani, MD
Status: Enrolling

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

Alternating neoadjuvant Gemcitabine-Nab-Paclitaxel and nal-IRI with 5-Fluorouracil and folinic acid (Leucovorin) regimens in resectable and borderline resectable pancreatic cancer, A Pilot Study
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

Analysis of Health Outcome of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

 

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A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

VM-BRI repository for early detection of pancreas cancer (VM-BRIDPAN)
Principal Investigator: Margaret Mandelson, PhD
Status: Closed to Enrollment

Prostate Cancer

NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)
Principal Investigator: Huong Pham, MD and John Paul Flores, MD
Status: Enrolling

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
Principal Investigator: Huong Pham, MD and John Paul Flores, MD
Status: Enrolling

 

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Principal Investigator: Joseph Rosales, MD
Status: Closed to Enrollment

A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Principal Investigator: John Paul Flores, MD
Status: Closed to Enrollment

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A PHASE III TRIAL OF SHORT TERM ANDROGEN DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE CANCER PATIENTS WITH A RISING PSA AFTER RADICAL PROSTATECTOMY.
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for localized intermediate risk prostate cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

 

Skin Cancer

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-risk Melanoma
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment