Skip to main content
Summit Health provides state-of-the-art medical advances and technology by offering novel treatment options to patients through clinical research.

Our Research Review Committee is comprised of Summit Health physicians and staff who manage all medical clinical trials, determine the scientific/ethical merits, and identify the potential impact of clinical research on patients.

What is Clinical Research?

Also known as clinical trials, clinical research involves patients who might benefit from new treatments that are not yet available. Research physicians use clinical research to test a medication, device, treatment approach, or medication dose. All research includes a panel of experts, also known as physician investigators, who decide how best to use the new treatment. The investigators also identify the types of patients who are likely to benefit most from the treatment. To be eligible for a clinical trial, the patients must fit certain criteria.

During a clinical trial, the researchers track and make note of all the changes (data) subjects experience as a result of the treatment they are given. The data are then used to make decisions about whether to use the medication, device, or treatment for a wide range of patients.

People who participate in medical research and clinical trials are volunteers. 

In general, clinical research helps determine whether:

  • A new medication, device, treatment, or dose is safe and effective for a specific type of patient
  • An already marketed medication or device can be used for a different disease or condition than the one for which it was originally intended
  • A new medication, device, or treatment is more effective than previous treatments for a disease or condition

Medical clinical trials also sometimes compare more than one medication, device, or treatment to determine which is the most effective.

What to Expect

Better research helps researchers and practitioners understand a disease, condition, or disability as well as examine and develop ways to prevent, diagnose, treat and improve quality of life.

It is the foundation of advances in healthcare processes, treatments, and technologies.

Clinical research helps determine whether treatments are safe and effective. It is used to help improve quality of life for people who are experiencing temporary as well as ongoing (chronic) illness. Clinical research can give participants hope for overcoming a disease or condition.

Types of Clinical Research Include:

  • Natural history studies to gather information about health and disease
  • Screening trials to identify how to detect a disease or condition
  • Diagnostic trials to determine best tests or procedures for diagnoses
  • Treatment trials that include medication(s), surgery, procedures, and other therapies
  • Prevention trials, including medication, vaccines, and lifestyle changes to help prevent disease from occurring and recurring
  • Quality of life (or supportive care) trials to identify ways to improve quality of life for people with chronic illness

About Clinical Research

All clinical research in the United States is conducted with the review and approval of an accredited, independent review board (IRB) comprised of physicians, and statisticians. The IRB reviews each clinical trial before and during research to ensure the trial is ethical, participants’ rights are protected, and that risks are minimal.

Clinical research involves a plan known as a protocol that:

  • Identifies the purpose of the trial
  • Outlines who can participate (eligibility)
  • Defines how long the study will last (study duration) and its phases
  • Describes the treatments, including frequency and dosages of medication
  • Gives details about tests and procedures
  • Identifies the researchers, including a principal investigator and coinvestigator(s)
  • Specifies information the researchers will gather
  • Suggests whether the data will be published

Informed consent is an important part of the clinical research process. It helps people decide whether to participate in a clinical trial. During informed consent, researchers explain details of the study, including its purpose, length, treatments involved, required tests and procedures, and benefits and risks. Participants also are given contact information so that participants know whom to call to get answers to their questions. Once a trial is underway, participants continue receiving information about the trial as part of informed consent.

All participants must sign a document of informed consent to engage in clinical research.

Informed consent is not a contract. All participants for clinical research are considered volunteers who are free deny treatments, test, or procedures as well as withdraw from the study. In some cases, however, denying treatments, tests, or procedures can mean being unable to complete (or becoming ineligible for) the trial.

Summit Providers

Our Research Team

Clinical researchers learn about disease processes when they compare healthy volunteers with patient groups in a clinical trial.

View Our Specialists

Enrolling in Clinical Research

Before enrolling in clinical research, potential participants must qualify for it.

If you are considering enrolling in clinical research, you should consider:

  • Risks, including:
    • Unpleasant side effects it might cause
    • Potential complications that require additional medical attention
    • Visits to the study site and time it takes from your other activities
    • The need for additional treatments, test, and hospital stays
    • Possible costs to you for traveling to the study site
  • Benefits, including:
    • Having an active role in your health care
    • Access to new treatments before they are available to others
    • Receiving medical care and attention from doctors and other health care practitioners
    • Contributing to the health and well-being of others

Once a new treatment, device, or intervention is proven safe and effective in clinical research, it can become a standard of medical practice.

For All Oncology Trials

Contact Michelle Mackenzie, RN, OCN, CRC at 973-436-1755 or mmackenzie@summithealth.com.

For All Other Studies

Contact Kelly Ritter, LPN, CCRC at 908-721-5673 or kritter@summithealth.com.


Current Active Trials - Last Updated July 31, 2023

In addition to the below trials, Summit Health has access to the Tempus TIME Trial™ Program which seeks to rapidly match patients to targeted clinical trials.

Service Type Principal Investigator Title Description
Cancer Services Gastrointestinal Dr. David Gallinson Colorectal - Advanced Disease 2nd Line NCT04793958 A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
Cancer Services Gastrointestinal Dr. David Gallinson Colorectal - 1st Line metastatic braf v600e NCT04607421 A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer
Cancer Services Gastrointestinal Dr. David Gallinson Metastatic colorectal cancer NCT04444622 Phase II open-label study to assess the safety and efficacy of stimvax® as third line therapy for metastatic colorectal cancer.
Cancer Services Gastrointestinal Dr. David Gallinson CLOSED TO ENROLLMENT
Metastatic Colorectal cancer - Maintenance NCT05141721
A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer
Cancer Services Breast Dr. Steven Papish ON ENROLLMENT HOLD ER+HER2- Metastatic Breast Cancer (VERU-024) NCT05065411 A Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm in Combination with Abemaciclib (Enobosarm Combination Group) compared to Estrogen Blocking Agent (Control Treatment Group) for the Second Line Treatment of ER+HER2- Metastatic Breast Cancer in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent plus Palbociclib or Ribociclib
Cancer Services Breast Dr. Winnie Polen Invasive Breast Cancer or DCIS NCT04397185 Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Cancer Services Breast Dr. Steven Papish 1st Line Met. TNBC - PD-L1+ US-592-6238 (ASCENT-03) NCT05382299 A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Cancer Services Breast Dr. Steven Papish 1st Line mTNBC - PD-L1+ US-592-6173 (ASCENT-04)  NCT05382286 A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Vs Treatment of Physician’s Choice & Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Cancer Services Breast Dr. Steven Papish TNBC w/residual disease. US-595-6184 (ASCENT 05) NCT05633654
NCT04457596
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Cancer Services Breast Dr. Steven Papish HER2 + Residual Breast Cancer NCT04457596 A011801, The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinb
Cancer Services Breast Dr. Steven Papish 1st Line Met TNBC NCT05374512 "A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02)"
Enrollment of patients with DFI ≤ 12 months IS CLOSED effective  Wednesday, March 1st, 2023
Cancer Services Breast Dr. Roshini George Met ER+/HER2- Met, Breast Cancer NCT05306340 A Phase III, Randomized, Open-Label, Multicenter Study Evaluating The Efficacy And Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus In Patients With Estrogen Receptor-Positive, Her2-Negative, Locally Advanced Or Metastatic Breast Cancer
Cancer Services Breast Dr. Steven Papish ER+HER2- metastatic breast cancer NCT05563220 A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)  
Cancer Services Gastrointestinal Dr. David Gallinson

1st Line Metastatic Cholangiocarcinoma Incyte - INCB52828-302 NCT03656536 

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)
Cancer Services Gastrointestinal Dr. David Gallinson

Pancreatic Cancer - 2nd Line NCT04825288

A Phase I/II randomized, double-blind, placebo-controlled trial (1-BETTER) examining XB2001 (anti-IL-1⍺ True Human antibody) in combination with ONIVYDE + 5-FU/LV (+folinic acid) in advanced pancreatic cancer
Cancer Services Gastrointestinal Dr. David Gallinson

Untreated Advanced Gastric and Gastroesophageal Cancer With FGFR2b Overexpression

PART 2 PHASE 3 Open FGFR2b overexpression is required for the part 2 (Phase 3) of the trial.  

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Cancer With FGFR2b Overexpression 
Cancer Services Genitourinary Oncology Dr. William Brown NMIBC-Unresponsive/High-Risk NCT04752722
Phase 1 closed - waiting for Phase 2 to open
EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients Who Have Been Incompletely Treated With BCG or Are BCG-Naïve (LEGEND STUDY)
Cancer Services Genitourinary Oncology Dr. Elan Diamond Muscle Invasive Bladder Cancer NCT04241185 A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Chemoradiotherapy (CRT) versus CRT Alone
Cancer Services Genitourinary Oncology Dr. Elan Diamond MIBC NCT04960709 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 Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Cancer Services Genitourinary Oncology Dr. Mutahar Ahmed Prostate Cancer NCT04263025 Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Cancer Services Genitourinary Oncology Dr. Elan Diamond mCRPC NCT03574571 DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Cancer Services Genitourinary Oncology Dr. Glen Gejerman  Prostate Cancer NCT04905069 Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body RadiothErapy SABRE
Cancer Services Genitourinary Oncology Dr. Karl Coutinho Urethral Stricture Disease Urotronic - STREAM
NCT05383274
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Cancer Services Genitourinary Dr. Thomas Mueller Renal Calculi (Device) NCT04519294 A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Ureteroscopic Laser Lithotripsy
Cancer Services Genitourinary N/A Hypogonadal Men NCT04976595 24 hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated with Natesto Nasal Testosterone Gel 
Cancer Services Gynecology Dr. Darlene Gibbon COMING SOON Ovarian/Endometrial - metastatic  A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status
Cancer Services Head & Neck Dr. KarLeung Siu Oropharyngeal Cancer A Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of clonidine mucoadhesive buccal tablet to placebo to prevent chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer
Cancer Services Hematology Dr. Benjamin Freeman CLL-Previously treated  (Acalabrutinib) NCT04116437  A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib
Cancer Services Hematology Dr. KarLeung Siu CLL Recurrent NCT04895436 A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax- Obinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia
Cancer Services Hematology Dr. Benjamin Freeman B-Cell Malignancies
NCT05207670
An Open-Label, Multicenter, Phase II Trial Evaluating The Safety, Efficacy, And Pharmacokinetics Of Subcutaneous Mosunetuzumab Monotherapy In Patients With Select B-Cell Malignancies
Cancer Services Hematology Dr. William DeRosa NHL - Observational
NCT04982471
"Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Cancer Services Hematology Dr. David Gallinson R/R CLL/NHL NCT05515406 A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
Cancer Services Hematology Dr. William DeRosa R/R MM NCT05590377 A Phase 1/2a Open-label Study to Study  Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed/Refractory Multiple MyelomaA Study of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed/Refractory Multiple Myeloma
Cancer Services Hematology Dr. KarLeung Siu Myelofibrosis NCT04468984 Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed /Refractory Myelofibrosis (TRANSFORM-2)
Cancer Services Hematology Dr. Benjamin Freeman COMING SOON R/R Follicular; MZL NCT05100862 A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Cancer Services Hematology Dr. William DeRosa COMING SOON Untreated DLBCL - Unfit/Frail pts
NCT05144009
A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination with Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients with Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)
Cancer Services Hematology Dr. David Gallinson COMING SOON R/R CLL/SLL NCT04965493 A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322).
Cancer Services Thoracic Dr. Sarada Gurubhagavatula Lung - Metastatic EGRF mutant NCT03909334 An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC
Cancer Services Thoracic Dr. Sarada Gurubhagavatula NSCLC - Stage 1A2-1A3 EGRFm NCT05120349 A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2)
Cancer Services Thoracic Dr. Sarada Gurubhagavatula NSCLC - Stage III NCT05211895 A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy (PACIFIC-8)
Cancer Services Thoracic Dr. William DeRosa NSCLC Stage IIIB  EGRF mut. NCT05493501 A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, versus Aumolertinib with Chemotherapy, versus Osimertinib for Patients with Metastatic NSCLC and an EGFR Mutation
Cancer Services Thoracic Dr. William DeRosa NSCLC - Stage IV NCT05403385                         --- The 40mg Cohort is filled with all 3 subjects continuing on study treatment
- The 60mg Cohort is temporarily closed: 2 subjects are in active screening, and 2 subjects having initiated treatment earlier
- New Screenings are ON HOLD at this time.
 
A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy
Cancer Services Thoracic Dr. William DeRosa COMING SOON NSCLC Stage III/IV A Real-World Prospective Observational Study of the DAWN-LUNG Clinical Outcome Prediction and Recurrence Risk Glycoproteomic Liquid Biopsy Test
Cancer Services Thoracic Dr. Sarada Gurubhagavatula COMING SOON HCRN-LUN21-497 NCT05617313 A Phase II Study of GT103 in Combination with Pembrolizumab in Refractory, Metastatic
Non-Small Cell Lung Cancer
Cancer Services Thoracic Dr. KarLeung Siu BTCRC-LUN19-396 NCT04367311 A phase II study of adjuvant treatment with cisplatin-based chemotherapy plus
concomitant atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select stage III
[any T1-3 N1-2 and T4N0-2] resected non-small cell lung cancer (NSCLC) and the clearance of
circulating tumor DNA (ctDNA)
Big Ten Cancer Research Consortium BTCRC-LUN19-396
Cancer Services Thoracic N/A CLN-081-001 NCT04036682 A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy