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 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 firstname.lastname@example.org.
For All Other Studies
Contact Kelly Ritter, LPN, CCRC at 908-721-5673 or email@example.com.
Current Active Trials - Last Updated April 7, 2021
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.
|Cancer Services||Breast||Dr. Steven Papish||Neo-Adjuvant Breast NCT04109066||A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, ER+, HER2- Primary Breast Cancer|
|Cancer Services||Breast||Dr. Steven Papish||CLOSED TO ENROLLMENT Neo-Adjuvant Breast NCT04075604||Randomized, Non-comparative Neoadjuvant Phase II Study in Patients with ER+/HER2- Breast Cancer > 2 cm with Safety Run-in, Assessing Nivolumab + Abemaciclib or Palbociclib +Anastrozole|
|Cancer Services||Breast||Dr. Steven Papish||Met. HER2+ Breast Cancer NCT03975647||Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer|
|Cancer Services||Breast||Dr. Steven Papish||CLOSED TO ENROLLMENT 1st line Metastatic Triple Negative BC weekly SGN-LIV1A dosing schedule NCT03310957||Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic
Triple Negative Breast Cancer
|Cancer Services||Breast||Dr. Steven Papish||Wait list only HR+/HER2- MBC NCT04060862||A Phase 1B/III Study of Ipatasertib + Palbociclib and Fulvestrant vs. Placebo + Palbociclib and Fulvestrant in HR+/HER2- locally Advanced Unresectable or Metastatic Breast Cancer|
|Cancer Services||Breast||Dr. Steven Papish||
Met. HR+ HER2-Breast Cancer NCT03560531
|A phase 1/2 open label, multicenter study to Assess the safety, tolerability, Pharmacokinetics, and anti-tumor activity of Zn-c5 alone and in combination with Palbociclib in subjects with estrogen-receptor Positive, human epidermal growth factor Receptor-2 negative advanced breast cancer|
|Cancer Services||Breast||Dr. Steven Papish||Met. HR+ HER2- Breast Cancer NCT04514159||A Phase 1B Study of ZN-c5 in Combination with Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer.|
|Cancer Services||Breast||Dr. Steven Papish||
TEMPUS TIME TRIAL
Elaine I ESR1 mutation NCT03781063
|Evaluation of Lasofoxifene verses Fulvestrant in Advanced or Metastatic ER+/HER- Breast Cancer with an ESR1 Mutation|
|Cancer Services||Breast||Dr. Steven Papish||
TEMPUS TIME TRIAL
Elaine II ESR1 mutation NCT04432454
|Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEII)|
|Cancer Services||Breast||Dr. Steven Papish||
TEMPUS TIME TRIAL
Tenacity Notch Activation NCT04461600
|A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer (TENACITY)|
|Cancer Services||Gastrointestinal||Dr. David Gallinson||Metastatic Cholangiocarcinoma 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. Steven Papish||TEMPUS TIME TRIAL DisTinGuish DKK-1 NCT04363801||A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer (DisTinGuish)|
|Cancer Services||Genitourinary||Dr. Benjamin Freeman||Metastatic Castration-resistant Prostate Cancer NCT04100018||A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX: CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)|
|Cancer Services||Genitourinary||Dr. Steven Papish||TEMPUS TIME Trial NORSE FGFR Mutations NCT03473743||A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer|
|Cancer Services||Genitourinary||Dr. Steven Papish||TEMPUS TIME Trial Prevalence Pre-screen Met. Prostate DNA-repair gene defects NCT03871816||A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer|
|Cancer Services||Genitourinary||Dr. Steven Papish||TEMPUS Time Trial Amplitude BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, PALB2, RAD51B, RAD54L NCT04497844||A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)|
|Cancer Services||Genitourinary||Dr. Steven Papish||TEMPUS TIME Trial Magnitude BRCA1/2 NCT03748641||A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)|
|Cancer Services||Genitourinary||Dr. Steven Papish||
TEMPUS TIME Trial-Coming Soon
|Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC|
|Cancer Services||Gynecologic||Dr. Darlene Gibbon||Cervical - 2nd Line NCT03894215||A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (Anti-PD-1) as a Monotherapy or Combination Therapy With AGEN1884 (Anti-CTLA4) or With Placebo in Women With Recurrent Cervical Cancer (Second Line) – RaPiDs|
|Cancer Services||Hematology||Dr. Benjamin Freeman||ENROLLMENT CURRENTLY ON HOLD CLL-Previously treated 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. Benjamin Freeman||DLBCL - R/R (2 or more prior lines) NCT04404283||A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)|
|Cancer Services||Hematology||Dr. Benjamin Freeman||CLOSING - Follicular Lymphoma TN NCT02947347||A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma|
|Cancer Services||Hematology||Dr. Benjamin Freeman||FL R/R Limit 2 prior lines NCT02793583||A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin’s Lymphoma|
|Cancer Services||Hematology||Dr. Benjamin Freeman||Follicular Lymphoma >2 prior systemic therapies NCT03332017||An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma|
|Cancer Services||Hematology||Dr. David Gallinson||Mantel Cell (Registry) NCT03816683||Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients with Mantle Cell Lymphoma Treated with Novel Agents|
|Cancer Services||Hematology||Dr. David Gallinson||CLOSING Part 2 MZL >1 prior therapy Part 3 FL CLOSED Part 4 DLBCL >1 prior therapy NCT02180711||An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma|
|Cancer Services||Hematology||Dr. Benjamin Freeman||ENROLLEMENT CLOSED BTK Refractory MCL 2+ prior lines NCT02793583||A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin’s Lymphoma|
|Cancer Services||Hematology||Dr. David Gallinson||Enrollment on Hold R/R Grades 1-3a FL, MZL, MCL, CLL/SLL NCT04014205 Cohort 1 enrollment closed||A Phase I，Multicenter, Open-Label, Dose Escalation Study of a Novel Bruton’s Tyrosine Kinase Inhibitor, ICP-022, in Patients with Relapsed/Refractory B-Cell Malignancies|
|Cancer Services||Hematology||Dr. William DeRosa||Multiple Myeloma NCT03901963||A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant|
|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||Thoracic/Head & Neck||Dr. Sarada Gurubhagavatula||Oral mucositis H/N cancer NCT03689712||A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer|
|Cancer Services||Thoracic/Head & Neck||Dr. Sarada Gurubhagavatula||Previously Treated Advanced NSCLC NCT03906071||A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy in Combination with Checkpoint Inhibitor Therapy|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||NSCLC - Biomarker Study||A Non-interventional Biomarker Study on the Molecular Evaluation of Archival Tumor Tissue in Subjects with Non-Small Cell Lung Cancer (NSCLC)|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||NSCLC - Previously Treated NCT04303780||A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C|
|Cancer Services||Thoracic/Head & Neck||Dr. Sarada Gurubhagavatula||NSCLC - with documented EGFR mutations del19, L858R, with or without T790M mutation NCT02099058||A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||TEMPUS TIME Trial KEAPSAKE KEAP1/NRF2 (NFE2L2)-Mutations NCT04265534||KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC (KEAPSAKE)|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||TEMPUS TIME Trial Insight 2 MET amplification & EGFR mutations NCT03940703||A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||TEMPUS TIME Trial Mariposa - EGFR Mutation NCT04487080||A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA)|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||TEMPUS TIME Trial Papillion - EGFR Mutation NCT04538664||A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON)|
|Cancer Services||Thoracic/Head & Neck||Dr. Steven Papish||TEMPUS TIME Trial CHRYSALIS - EGRF & MET NCT02609776||Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS)|
|Cancer Services||Basket Trials||Dr. David Gallinson||Solid Tumors w/FGFR mutation NCT03822117||A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)|