Cancer Clinical Research

Clinical Trials

Cancer

Benaroya Research Institute and Virginia Mason Medical Center conduct cancer clinical trials to find better ways to treat and prevent cancer. Our studies include the use of chemotherapy, radiation, and targeted therapies, as well as contributing to the development of diagnostic tests and improving quality of life/symptom management. More than 100 cancer-related clinical studies are conducted at Virginia Mason Medical Center each year, including studies sponsored by the National Cancer Institute and industry-sponsored trials.

Clinical Research Studies in Cancer

We have ongoing clinical research studies in several areas of cancer research. Studies labeled as “Enrolling” are actively accepting new participants while studies labeled as “Closed to Enrollment” are still active but no longer seeking new participants.

Please email Cancer Clinical Research or call (206) 287-6270 for more information.

Bladder Cancer

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

Does the use of a post-operative pedometer impact the return of bowel function and narcotic use following radical cystectomy?
Principal Investigator: Alvaro Lucioni, MD
Status: Enrolling

Adjuvant study of MK-3475 (Pembrolizumab) in muscle invasive and locally advanced urothelial carcinoma (Ambassador) versus observation
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Blood Cancer

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

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

SWOG S0016 A Phase III Trial of CHOP Plus Rituximab versus CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for the Treatment of Newly Diagnosed Follicular Non-Hodgkin’s Lymphoma
Principal Investigator: Huong Pham, 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

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

A Phase 3, Randomized, Open-Label, Multicenter Trial of Arv-471 Vs Fulvestrant in Participants with Estrogen Receptor-Positive, Her2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease
Principal Investigator: Meaghan O'Malley, MD
Status: Enrolling

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

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: Enrolling

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

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 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: Enrolling

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

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

A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer
Principal Investigator: Val Simianu, MD
Status: Enrolling

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

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 Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Under
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in patients with advanced Colorectal Carcinoma or Cholangiocarcinoma
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

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

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: Enrolling

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment
Evaluation of the Lasting Symptoms After Esophageal Resection (LASER) questionnaire in esophageal disease
Principal Investigator: Donald Low, MD
Status: Closed to Enrollment

Influence of Nutrition and SarcoPenia on Esophageal Cancer outcomes (INSPECT study)
Principal Investigator: Donald Low, MD
Status: Closed to Enrollment

Temporal variation in exhaled volatile organic compounds in response to therapeutic intervention in esophageal cancer patients
Principal Investigator: Donald Low, 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

CAN DIET AND EXERCISE MODULATE OVARIAN, FALLOPIAN TUBE AND PRIMARY PERITONEAL CANCER PROGRESSION-FREE SURVIVAL?
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Hepatobiliary Cancer (Liver and Biliary Tract)

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 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: Enrolling

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

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 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

A Single-arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

HIV/AIDS Malignancies

AMC-101, A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas
Principal Investigator: David Aboulafia, MD
Status: Enrolling

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

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: Enrolling

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

Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
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

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

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

Lung Cancer

A Phase II Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK)
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

ATEZOLIZUMAB + SBRT VERSUS SBRT ALONE IN HIGH RISK, EARLY STAGE NSCLC
Principal Investigator: Joseph Rosales, 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

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 1/1b 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 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

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

A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

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

PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

PRECISION PROMISE PLATFORM TRIAL FOR METASTATIC PANCREATIC CANCER
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

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

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

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 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