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
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
- T1c-T2, clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2.
- Grade 3 or Grade 2 (ER 1-10%)
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
- ER(-) and PgR(-) OR
- ER or PgR stains are positive in 1-9% of cells and neither is positive in ≥ 10% of cells.
- Primary tumor must be pT1-3;
- Nodes must be pN0-pN3b.
- If pN0 tumor must be ≥ 3.0 cm.
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
- ER-, PR- and HER2-negative
- Weakly ER or PR positive disease ≤ 5%
- Residual disease ≥ 1 cm and/or have positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3).
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.
- De novo metastatic disease or
- Locally recurrent or metastatic disease w/ prior therapy (≥ 6 months of completion)
- No Prior treatment with CD137 agonists or immunotherapy.
(New) BLOOD DRAW
Exact Science 2018-01 - Blood Sample Collection to Evaluate Biomarkers and to develop and validate a stool-based test for colorectal cancer in Subjects with Untreated Solid Tumors.
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.
Solid Tumor Matched Tissue & Blood Collection. Blood draw and Biopsy Tissue Collection
- Stage IV of any solid tumor type
- Patients scheduled to submit tissue for Caris as a part of their SOC.
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.
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)
ADJUVANT COLON (NEW VACCINE TRIAL)
BNT122-01A – Multi-site, open-label, Phase II, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients, irrespective of ctDNA status (Biomarker Cohort)
- Stage II (high risk) colon cancer
- At least 5 tumor neoantigents identified in the tumor sample
- Microsatellite instability high tumors
- Prior neo-adjuvant (RT)chemotherapy
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: (ON HOLD) 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
Stage IV squamous or non-squamous NSCLC
AB154CSP0002: (ON HOLD) A Phase 2 Study to evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination with AB122, and AB154 in Combination with AB122 and AB928 in Front-Line, Non Small Cell Lung Cancer
- Treatment naïve, metastatic squamous or non-squamous NSCLC
- High PD-L1 expression
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)
- Stage III (unresectable) or IV NSCLC.
- BMI < 20 kg/m2
- Weight loss of >2% within 6 months
ECOG/ACRIN EAY131 “MATCH” – Molecular Analysis for Therapy Choice (MATCH)
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
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.
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
(NEW) RARE GENITOURINARY CANCER
A31072: A phase II study of Ipilimumab, Cabozantinig and Nivolumab in rare Genitourinary Cancer (ICONIC)
HEAD AND NECK CARCINOMA
Locoregionally advanced w/ Contraindication to Cisplatin
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.
(New) POLYCYTHEMIA VERA
PTG-300-04: 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.