A clinical trial is a research study designed to evaluate the safety and effectiveness of new cancer treatment options. This type of research improves the treatment of cancer. As a result of these trials, cancer survival rates have increased, quality of life has improved and side effects have decreased for many patients.

Our Current Trials

BREAST

Neo-Adjuvant
BMS CA2097FL: A randomized multicenter, double-blind, placebo-controlled Phase 3 Study of Nivolumab vs. Placebo in combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in patients with high risk, estrogen receptor- Positive (ER+), HER2 negative. Primary Breast Cancer

Adjuvant
NRG-BR003:
A Randomized, Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High Risk Node-Negative Triple Negative Invasive Breast Cancer

Ovarian Suppression

(New) TOLMAR: Ovarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA): A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy in Premenopausal Subjects with Hormone-Receptor–Positive (HR+) and HER2 neu Negative Breast Cancer.

1st line  metastatic/advanced HER2 neu Positive

NRG-BR004 –A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer.

AR+/ER+/HER2- Metastatic Breast Cancer

(New) VERU : ARTEST - A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm Monotherapy Versus Active Control for the Treatment of AR+/ER+/HER2- Metastatic Breast Cancer in Patients with Androgen Receptor Nuclei Staining ≥40% Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 inhibitor

BLOOD DRAW

CARIS

Solid Tumor Matched Tissue & Blood Collection. Blood draw and Biopsy Tissue Collection

Trans Hit Bio

PAS-18CCF006 (New Study): Evaluation of the Clinical Performance of the PAXgene Blood ccfDNA Tube in Comparison to the BD Vacutainer K2EDTA Tube Using the therascreen® PIK3CA RGQ PCR Kit

BLOOD DRAW AND STOOL SAMPLE

Exact Science 2018-01B - Blood and Stool Sample Collection to Evaluate Biomarkers and to develop and validate a stool-based test for colorectal cancer in Subjects with Untreated Solid Tumors.

COLON

ADJUVANT CRC

BNT122-01A 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 (Main Trial).

BNT000-001 – Epidemiological study to monitor study participants with resected Stage II (high risk) or Stage III colorectal cancer for circulating tumor DNA before, during and after their treatment with adjuvant chemotherapy.

A021502 – 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 (ATOMIC Trial)

LUNG - NON-SMALL CELL

(Temporarily Closed to accrual 11/12/2021)
NRG-LU002
:
Maintenance systemic therapy vs local consolidative therapy (LCT) plus maintenance systemic therapy for limited metastatic non-small cell lung cancer (NSCLC): a randomized phase II/III trial

MOLECULAR ANALYSIS

ECOG/ACRIN EAY131 “MATCH” – Molecular Analysis for Therapy Choice (MATCH)

PROSTATE

NRG-GU005- Phase lll IGRT and SBRT vs IGRT and Hypofractionated IMRT for localized intermediate risk prostate cancer

Pfizer C3441021: (ON HOLD) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib with Enzalutamide in Metastattic Castration-Resistant Prostate Cancer.

RTOG: STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features.

PREDICT-RT*
Temporarily closed to accrual
*Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with Radiation (New)

NRG-GU009: Parallel Phase III Randomized Trials for High Risk Prostate Cancer evaluation de-intensification for lower genomic risk and intensification of concurrent therapy for higher genomic risk with radiation.

RARE GENITOURINARY CANCER

A031072:   A phase II study of Ipilimumab, Cabozantinig and Nivolumab in rare Genitourinary Cancer (ICONIC)

HEAD AND NECK CARCINOMA

Locoregionally advanced w/ Contraindication to Cisplatin
Temporarily closed to accrual
NRG-HN004: Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin.

Recurrent or Metastatic Head and Neck Cancer (HNSCC) (NEW)
VERSATILE-002 (PDS0101-HNC-201): A Phase II, Open-Label, Multi-Center Study of PDS0101 (ImmunoMAPK - RDOTAP/HPV-16 E6 & E7 Peptides) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy as a First Line Treatment in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-RiskHuman Papillomavirus-16 (HPV16) Infection

SOLID TUMORS

MPH313-1-02: A phase 1b/2 open-label study of the efficacy and safety of etigilimab (MPH313) administered in combination with nivolumab to subjects with locally advanced or metastatic solid tumors.

Incyte 301 (NEW)

R/R Follicular Lymphoma or R/R Marginal Zone Lymphoma
INCMOR 0208-301: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

How Can I Participate in a Clinical Trial?

We have a number of trials available and will offer one to you if appropriate. Keep in mind that most clinical trials have strict eligibility criteria to protect patients and provide the best chance for success.  Age,  gender, cancer type and prior treatments may be included in  the selection criteria.  That means not all patients are eligible for a clinical trial.

What are the phases of a Clinical Trial?

Phase I trials assess the safety of a new medication or treatment.

Phase II trials also assess the safety of a new medication or treatment, but often measure the effectiveness of those treatments as well.

Phase III trials measure the effectiveness and safety of a new medication or treatment compared to the existing best practice.

What if I Get a Placebo?

Cancer patients participating in clinical trials will always receive a treatment that is equivalent to, or possibly better than, the standard treatment.  Placebo trials are never used when there is a potentially effective therapy available. Your doctor and research team can explain the details of placebo-controlled trials to you during your office visits.

Will My Clinical Trial Work?

There’s no guarantee that your clinical trial will work. However, before every clinical trial starts, the designers of the trial must present evidence that convinces the Food and Drug Administration (FDA) that the trial is a logical treatment option.

Can I Quit My Clinical Trial?

Participation in clinical trials is completely voluntary. Every participant in a clinical trial signs an informed consent form that outlines the trial’s potential benefits and risks. During the trial, the research team will monitor you closely and help manage any side effects you may experience. You can decide to stop participating in the trial at any time.