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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.

Michelle Mackenzie, RN, OCN, CCRC

out of 5
Clinical Research, Oncology and Hematology

Kelly M. Ritter, LPN, CCRC

out of 5
Clinical Research

For more information regarding our oncology trials, please call 973-436-1755 or email

Michelle Mackenzie, RN, OCN, CRC at mmackenzie@summithealth.com
Kelly Ritter, LPN, CCRC at kritter@summithealth.com


Current Active Trials - Last Updated May 15, 2025

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.

ServiceTypePrincipal InvestigatorTitleDescription
Cancer ServicesBasket Trial 

Solid Tumors

Artios (ART0380C001)

NCT04657068

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors
Cancer ServicesBasket Trial 

Advanced Solid Tumors

EIK1003-001

NCT06253130

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors
Cancer ServicesBasket Trial 

Advanced Tumors

FORE (F8394-201)

NCT05503797

A Phase 2 Master Protocol to assess the efficacy and safety of
FORE8394, an inhibitor of BRAF Class 1 and Class 2 alterations,
in participants with cancer harboring BRAF alterations  Refer to the individual subprotocols for their inclusion criteria
Cancer ServicesBasket Trial 

Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

Servier (CL1-95035-001)

NCT06188702

A Phase 1, open-label, multicenter clinical trial of
S095035 (MAT2A inhibitor) in adult participants with
advanced or metastatic solid tumors with homozygous
deletion of MTAP
Cancer ServicesBasket Trial 

Solid tumor malignancy or lymphoma

VM Oncology

NCT03556228

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety,
Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma (Version 9); Protocol No.: VMO-01C
Cancer ServicesBreastDr. Steven Papish

Early Breast Cancer with High Risk of Recurrence    

NCT06492616

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)
Cancer ServicesBreast

Dr. Jennifer Reeder

Dr. Steven Papish

Breast Cancer Survivors - Cognitive Impairment

NCT05896189

NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
Cancer ServicesBreastDr. 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 ServicesBreastDr. Winnie Polen

Malignant breast tumors </=15 mm

NCT03463954

Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm
Cancer ServicesBreastDr. 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 ServicesBreast 

Advanced/​Metastatic HR+/​HER2- Breast Cancer

CAPItello-292

NCT04862663

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Cancer ServicesBreast 

Locally Advanced or Metastatic ER+/​HER2- Breast Cancer with an ESR1 Mutation

Sermonix (SMX22-002 Elaine III)

NCT05696626

An Open Label, Randomized, Multicenter Study Comparing the
Efficacy and Safety of the Combination of Lasofoxifene and
Abemaciclib to the Combination of Fulvestrant and Abemaciclib for
the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation
Cancer ServicesGastrointestinal

Dr. Steven Papish

Dr. Jennifer Reeder

 

Stage IIB, IIC, or Stage III colon adenocarcinoma PI

NCT05174169

NRG-GI008: Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA)
Cancer ServicesGastrointestinal 

Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

GSK Azur-2

NCT05855200

A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Cancer ServicesGastrointestinal 

Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

CLARITY-Gastric 01

NCT06346392

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY-Gastric 01)
Cancer ServicesGastrointestinal 

Locally advanced /unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma

Servier CL1-95029-002

NCT06116136

Open Label, Non-randomized, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of S095029 (Anti-NKG2A Antibody) as a Part of Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer
Cancer ServicesGastrointestinal 

Advanced Tumors

FORE (F8394-201)

NCT05503797

A Phase 2 Master Protocol to assess the efficacy and safety of
FORE8394, an inhibitor of BRAF Class 1 and Class 2 alterations,
in participants with cancer harboring BRAF alterations
Cancer ServicesGastrointestinal 

Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene 

Servier (CL1-95035-001)

NCT06188702

A Phase 1, open-label, multicenter clinical trial of
S095035 (MAT2A inhibitor) in adult participants with
advanced or metastatic solid tumors with homozygous
deletion of MTAP
Cancer ServicesGastrointestinal 

Solid tumor malignancy or lymphoma

VM Oncology

NCT03556228

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety,
Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma (Version 9); Protocol No.: VMO-01C
Cancer ServicesGenitourinary OncologyDr. Gordon Brown

Microhematuria           

NCT06394869
 

Cystoscopic REDuction In BLadder Evaluations for microhematuria - A prospective randomized, controlled, clinical utility study for evaluation of microhematuria (The CREDIBLE study)
Cancer ServicesGenitourinary OncologyDr. Gordon Brown

NMIBC-Unresponsive/High-Risk

NCT04752722

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 ServicesGenitourinary OncologyDr. Gordon Brown

Prostate Cancer

NCT05712473
 

A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the use of PYLARIFY®(piflufolastat F 18) PET in Patients with Newly Diagnosed and Recurrent Prostate Cancer
Cancer ServicesGenitourinary OncologyDr. Glen Gejerman

Prostate Cancer

NCT06496256

Randomized trial of Barrigel® to increase distance between the
rectum and prostate bed to decrease rectal dose in patients receiving moderately hypofractionated radiation therapy who have had recurrence of prostate cancer after prostatectomy.
Cancer ServicesGenitourinary OncologyDr. Karl Coutinho

Urethral Stricture Disease Urotronic - STREAM

NCT05383274

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Cancer ServicesGenitourinary Oncology 

Advanced Urothelial Carcinoma

FUJIFILM (FF10832-PEM-201)

NCT05318573

A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Cancer ServicesGenitourinary OncologyDr. Gordon Brown

OPENING SOON

BRCAm localized high-risk prostate cancer  

 

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
Cancer ServicesHematologyDr. Steven Papish

1st Line CLL          

NCT06637501

Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy
in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia
Cancer ServicesHematologyDr. Steven Papish

CLL

NCT04170283

An Open label, Multi center, Long term Extension Study of
Zanubrutinib (BGB 3111) Regimens in Patients with B cell
Malignancies
Cancer ServicesHematologyDr. Steven Papish

R/R B-Cell Malignancies

NCT05006716

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
Cancer ServicesHematologyDr. Steven Papish

Waldenström Macroglobulinemia Observational

NCT05640102

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia
Cancer ServicesHematology 

MDS

Servier PyramIDH Study MDS

NCT06465953

A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) monotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study)
Cancer ServicesThoracicDr. Lalitha Anand

NSCLC - 2nd Line

NCT06012435

A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer
Cancer ServicesThoracicDr. Lalitha Anand

Early Stage II-IIIb NSCLC

NCT06161441

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination with Chemotherapy versus Cemiplimab in Combination with Chemotherapy in Patients with Resectable Early Stage (Stage II to IIIB [N2]) NSCLC
Cancer ServicesThoracicDr. Lalitha Anand

mNSCLC w/EGRFm

NCT06417814

AstraZeneca, D516KC00001, A Phase III, Open Label, Sponsor-Blind, Randomized Study of Dato DXd With or Without Osimertinib Versus Platinum-Based Doublet Chemotherapy for Patients with EGFR-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15), 284004
Cancer ServicesThoracic 

Metastatic NSCLC                               AstraZeneca (eVOLVE-Lung02)

NCT05984277

A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, 
Open-Label, Global Study to Determine the Efficacy of 
Volrustomig (MEDI5752) Plus Chemotherapy Versus 
Pembrolizumab Plus Chemotherapy for First-Line Treatment of 
Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) 
(eVOLVE-Lung02)
Cancer ServicesThoracic 

Metastatic NSCLC Patients

AstraZeneca (Triton)

NCT06008093

A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/​or Co-mutations in STK11, KEAP1, or KRAS (TRITON)
Cancer ServicesThoracic 

Advanced Non-squamous NSCLC With High PD-L1 Expression TROPION-Lung10

NCT06357533

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
Cancer ServicesThoracic 

First-line  Locally Advanced or Metastatic NSCLC With HER2-activating Mutations

Bayer SOHO 02 (BAY 2927088 / 22615)

NCT06452277

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations
Cancer ServicesThoracic 

Boehringer Ingelheim Beamion-LUNG 2 (1479-0008)

NCT06151574

Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
Cancer ServicesThoracic 

Advanced NSLC

FUJIFILM (FF10832-PEM-201)

NCT05318573

A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Cancer ServicesThoracic 

Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Mirati KRYSTAL-7 (849-007)

NCT04613596

MATCHING ON HOLD

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Cancer ServicesThoracic 

NSCLC W/KRAS G12V

RevMed (RMC-6291-101)

NCT06128551

MATCHING ON HOLD

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
Cancer ServicesThoracic 

METASTATIC 
ROS1-POSITIVE NSCLC

Nuvation Bio EAP

NCT06841874

EXPANDED ACCESS PROGRAM OF TALETRECTINIB
IN PATIENTS WITH ADVANCED OR METASTATIC 
ROS1-POSITIVE NSCLC
Cancer ServicesThoracic 

Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma

(eVOLVE-HNSCC)

NCT06129864

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)