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
NSABP B-55 –Phase III Study to Assess the Efficacy and Safety of Olaparib vs Placebo as Adjuvant Treatment in Patients with Germline BRCA ½ Mutations and High Risk HER2 Negative Primary Breast Cancer who have completed Definitive Lovcal Treatment and Neoadjuvant or Adjuvant Therapy
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
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.
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: Phase 3 Study of FPA144 vs Placebo in Combination with Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer.
HEAD AND NECK
Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation
Soligenix IDR-OM-02 : A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
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.
Bristol Myers Squibb CA209817- A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer.
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)
LUNG LIMITED SMALL CELL
CALGB 30610 – Phase 3 Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide
ECOG/ACRIN EAY131 “MATCH” – Molecular Analysis for Therapy Choice (MATCH)
NRG-GY005 – A Randomized, Phase II/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, Fallopian Tube or Primary Peritoneal Cancer (COCOS)
NRG-GY009 - 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
EMD Serono MS201943-0029-A Phase II, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of M6620 in Combination with Avelumab and Carboplatin in Comparison to Standard of Care Therapy in Participants with PARPi-resistant Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube 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.
Progressed Following Platinum-based Chemotherapy
Bioclin B-70-U22 – (ON HOLD) A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined with Pembrolizumab in Subjects with Locally Advanced or Metastatic Urothelial Carcinoma who have Progressed Following Platinum-based Chemotherapy
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.