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
Neoadjuvant Chemotherapy +/- Immunotherapy and Adjuvant ET in high risk ER(+)/HER2
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
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
Triple Negative/ Residual
SWOG-1418/BR006 – A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with _> 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy
1st line metastatic/advanced
Novartis CLEE011A2207– A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the tx of pre- and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease
Exact Science 2018-01: Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Solid Tumors.
Exact Science 2018-02: Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Hematologic Malignancies.
PREVENTION OF CHEMOTHERAPY INDUCED
PledPharma AB: A Phase 3, double-blind, multicenter, placebo-controlled, study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in patients with first-line metastatic colon cancer
GASTRIC & GASTROESOPHAGEAL
Five Prime: (ON HOLD) Phase 3 Study of FPA144 vs Placebo in Combination with Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer. -ON HOLD
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
A151216: Adjuvant Lung Cancer Enrichment Marker Identification an Sequencing Trial (ALCHEMIST)
(Genetic Testing for Patients with Resectable or Resected Lung Cancer) Prior to enrollment in A081105 or E4512
EGFR Mutant Patients
A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor (EGFR) Mutant NSCLC
ALK Fusion Protein Patients
E4512: A Phase III Double-Blind Trial of Surgically Resected Early Stage NSCLC: Crizotinib vs Placebo for Patients with Tumors with ALK + Tumors.
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
CACHEXIA and NSCLC Patients
Helsinn ANAM-17-21: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of anamorelin HCI for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced non-small cell lung cancer ( NSCLC)
ECOG/ACRIN EAY131 “MATCH” – Molecular Analysis for Therapy Choice (MATCH)
NRG-GY005 – A Randomized, Phase III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or Refractory Ovarian, Cancer (COCOS)
NRG-GY009 - (ON-HOLD) -A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/ Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/ Bevacizumab in Platinum Resistant Ovarian Cancer
NRG-GU005- Phase lll IGRT and SBRT vs IGRT and Hypofractionated IMRT for localized intermediate risk prostate cancer
Pfizer C3441021: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib with Enzalutamide in Metastattic Castration-Resistant Prostate Cancer.
PMF, Post-PV MF, Post-ET MF
Samus, Pharmaceuticals: Phase 1b Study of PU-H71 for the Treatment of Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), Treated with Ruxolitinib
EMD Serono MS201964-0001: A Multicenter, Open-Label, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination with Avelumab with and without Palliative Radiotherapy in Participants with Selected Advanced Solid Tumors.
Janssen68284528MMY4001: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients with Relapsed and/or Refractory Multiple Myeloma Who Received at least 3 prior lines of Therapy Including PI, IMid, and CD38 Monoclonal Antibody Treatment.
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.