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

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.

Adjuvant Endocrine Therapy

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence.

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).

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)

Renal Collecting duct, bladder plasmacytoid, sarcomatoid bladder, urethral carcinoma (which allows any histology) and bone only (which allows for any GU histology, except prostrate)

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 CLOSED
• Cohort A2: patients with untreated FL and low-tumor burden
• Cohort B: elderly patients with untreated DLBCL
• Cohort C: patients with untreated MZL CLOSED
• Cohort D: patients with R/R MCL CLOSED
• Cohort E: patients with R/R RT or R/R tFL CLOSED

CLL / SLL

LOXO-BTK-20022: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

POLYCYTEMIA VERA

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

 

 

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.