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.

Our Research Team
Clinical researchers learn about disease processes when they compare healthy volunteers with patient groups in a clinical trial.
View Our SpecialistsEnrolling 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
Clinical Research, Oncology and HematologyKelly M. Ritter, LPN, CCRC
Clinical ResearchFor 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.
Service | Type | Principal Investigator | Title | Description |
---|---|---|---|---|
Cancer Services | Basket Trial | Solid Tumors Artios (ART0380C001) | 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 Services | Basket Trial | Advanced Solid Tumors EIK1003-001 | 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 Services | Basket Trial | Advanced Tumors FORE (F8394-201) | 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 Services | Basket Trial | Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene Servier (CL1-95035-001) | 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 Services | Basket Trial | Solid tumor malignancy or lymphoma VM Oncology | 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 Services | Breast | Dr. Steven Papish | Early Breast Cancer with High Risk of Recurrence | 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 Services | Breast | Breast Cancer Survivors - Cognitive Impairment | NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial | |
Cancer Services | Breast | Dr. Winnie Polen | Invasive Breast Cancer or DCIS | Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer |
Cancer Services | Breast | Dr. Winnie Polen | Malignant breast tumors </=15 mm | Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm |
Cancer Services | Breast | Dr. Steven Papish | ER+HER2- metastatic breast cancer | 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 | Breast | Advanced/Metastatic HR+/HER2- Breast Cancer CAPItello-292 | 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 Services | Breast | Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation Sermonix (SMX22-002 Elaine III) | 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 Services | Gastrointestinal |
Stage IIB, IIC, or Stage III colon adenocarcinoma PI | NRG-GI008: Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA) | |
Cancer Services | Gastrointestinal | Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer GSK Azur-2 | 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 Services | Gastrointestinal | Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma CLARITY-Gastric 01 | 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 Services | Gastrointestinal | Locally advanced /unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma Servier CL1-95029-002 | 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 Services | Gastrointestinal | Advanced Tumors FORE (F8394-201) | 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 Services | Gastrointestinal | Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene Servier (CL1-95035-001) | 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 Services | Gastrointestinal | Solid tumor malignancy or lymphoma VM Oncology | 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 Services | Genitourinary Oncology | Dr. Gordon Brown | Microhematuria | Cystoscopic REDuction In BLadder Evaluations for microhematuria - A prospective randomized, controlled, clinical utility study for evaluation of microhematuria (The CREDIBLE study) |
Cancer Services | Genitourinary Oncology | Dr. Gordon Brown | NMIBC-Unresponsive/High-Risk | 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. Gordon Brown | Prostate Cancer | 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 Services | Genitourinary Oncology | Dr. Glen Gejerman | Prostate Cancer | 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 Services | Genitourinary Oncology | Dr. Karl Coutinho | Urethral Stricture Disease Urotronic - STREAM | Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters |
Cancer Services | Genitourinary Oncology | Advanced Urothelial Carcinoma FUJIFILM (FF10832-PEM-201) | 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 Services | Genitourinary Oncology | Dr. 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 Services | Hematology | Dr. Steven Papish | 1st Line CLL | 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 Services | Hematology | Dr. Steven Papish | CLL | An Open label, Multi center, Long term Extension Study of Zanubrutinib (BGB 3111) Regimens in Patients with B cell Malignancies |
Cancer Services | Hematology | Dr. Steven Papish | R/R B-Cell Malignancies | 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 Services | Hematology | Dr. Steven Papish | Waldenström Macroglobulinemia Observational | A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia |
Cancer Services | Hematology | MDS Servier PyramIDH Study MDS | 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 Services | Thoracic | Dr. Lalitha Anand | NSCLC - 2nd Line | 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 Services | Thoracic | Dr. Lalitha Anand | Early Stage II-IIIb NSCLC | 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 Services | Thoracic | Dr. Lalitha Anand | mNSCLC w/EGRFm | 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 Services | Thoracic | Metastatic NSCLC AstraZeneca (eVOLVE-Lung02) | 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 Services | Thoracic | Metastatic NSCLC Patients AstraZeneca (Triton) | 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 Services | Thoracic | Advanced Non-squamous NSCLC With High PD-L1 Expression TROPION-Lung10 | 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 Services | Thoracic | First-line Locally Advanced or Metastatic NSCLC With HER2-activating Mutations Bayer SOHO 02 (BAY 2927088 / 22615) | 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 Services | Thoracic | Boehringer Ingelheim Beamion-LUNG 2 (1479-0008) | 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 Services | Thoracic | Advanced NSLC FUJIFILM (FF10832-PEM-201) | 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 Services | Thoracic | Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation Mirati KRYSTAL-7 (849-007) 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 Services | Thoracic | NSCLC W/KRAS G12V RevMed (RMC-6291-101) 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 Services | Thoracic | METASTATIC Nuvation Bio EAP | EXPANDED ACCESS PROGRAM OF TALETRECTINIB IN PATIENTS WITH ADVANCED OR METASTATIC ROS1-POSITIVE NSCLC | |
Cancer Services | Thoracic | Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma (eVOLVE-HNSCC) | 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) |