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

Advanced or Metastatic Breast Cancer previously treated with Endocrine Therapy

Elli Lilly/ J2J-OX-JZLC EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs investigator’s Choice of Endocrine Therapy, in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy.

  1. Relapsed with evidence of progression within 12 months of completion of (neo)adjuvant AI alone or in combination with a CDK4/6 inhibitor, with no treatment for advanced disease.
  2. Relapsed with evidence of progression >12 months from completion of (neo)adjuvant ET, with subsequent progression on or after only 1 line of therapy with an AI, alone or in combination with a CDK4/6 inhibitor. Patients may not have received any other prior therapy in the advanced/metastatic setting
  3. Presented de novo with metastatic disease, with subsequent progression on or after only 1 line of therapy with an AI, alone or in combination with a CDK4/6 inhibitor. Patients may not have received any other prior therapy in the advanced/metastatic setting

Ovarian Suppression

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.

BLOOD DRAW

EXACT-SCIENCES

2021-05: Whole blood and tumor tissue specimens from subjects who either have a diagnosis of cancer or recurrent cancer to evaluate biomarkers.

Trans Hit Bio

PAS-18CCF006: 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

COLON

ADJUVANT CRC

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.

BNT122-01 – 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).

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

 

PROSTATE

NRG-GU008: *INNOVATE: INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy Randomized Phase III Trial incorporating apalutamide and advanced imaging into salvage treatment for patients with node positive prostate cancer after radical prostatectomy.

NRG-GU009:PREDICT-RT*/*Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with
Radiation 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.

NRG-GU010 GUIDANCE: Parallel Phase III Randomized Trials of Genomic-risk stratified Unfavorable Intermediate risk prostate cancer: De-intensification And Intensification Clinical trial Evaluation

RARE GENITOURINARY CANCER

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

  • Plasmacytoid urothelial carcinoma
  • Renal medullary carcinoma
  • Bone only urothelial carcinoma or other non-prostate GU tumor
  • Urethra carcinoma / Other miscellaneous histologic variants of the urothelial carcinoma.

Recurrent or Metastatic Head and Neck Cancer (HNSCC)

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

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

Follicular Lymphoma/DLBCL/MZL/tFL

ML43389/MorningSun: An open-label, multicenter, Phase II Trial evaluating the safety, efficacy and pharmacokinetics of subcutaneous Mosunetuzumab monotherapy in patients with select B-Cell Malignancies.
• Cohort A1: patients with untreated FL and high-tumor burden
• Cohort A2: patients with untreated FL and low-tumor burden
• Cohort B: elderly patients with untreated DLBCL
• Cohort C: patients with untreated MZL
• Cohort D: patients with R/R MCL
• Cohort E: patients with R/R RT or R/R tFL

Platinum Resistant Recurrent Ovarian Cancer

MK-3475-B96: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer.

POLYCYTEMIA VERA

PTG 300-11: A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients with Phlebotomy-Requiring Polycythemia Vera.

ESSENTIAL THROMBOCYTHEMIA - PharmaEssentia Better Science, Better Lives

PharmaEssentia A22-301: A Single-arm, Multicenter, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia.

 

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.