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Clinical Trials

CANCER RESEARCH

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Breast

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Advanced breast Cancer, metastatic breast cancer	Pfizer A5481082 NCT03280303	POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study	Age ≥ 18 years or older. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent. Documented HR+ (ER+ and/or PR+) tumor based on local standards Documented HER2- tumor based on local standards Physician had determined that treatment with palbociclib is indicated
Radiation Oncology	NCI Alliance A011401 NCT02750826	Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (BWELL)	Histologic diagnosis of invasive breast cancer within the past 12 months Her-2 negative Stage II or III breast cancer ER and PR negative: T2-3N0 or T0-3N1-3 ER and/or PR positive: T0-3N1-3 or T3N0 No history of other malignancy within past 4 years No comorbid conditions that would cause life expectancy ≤ 5 years No diabetes mellitus currently treated BMI ≥ 27
Recurrent or metastatic breast cancer	Daehwa 107CS-6 (OPERA) NCT03326102	A Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients with Recurrent or Metastatic Breast Cancer	Age ≥ 18 years or older. Confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination Diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples Received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting Life expectancy of ≥ 12 weeks Able to take oral medication Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale Measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1)
Breast Cancer: Gene expression profiling	Agendia FLEX Registry NCT03053193	MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)	Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) New primary lesion No metastatic disease No recurrent disease Life expectancy of ≥ 12 weeks No Stage 0 disease

Gastrointestinal

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Liver Humanitarian Device TX	MDS Nordion Contact Dr. George Khoriaty	Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere® (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol	Hepatocellular carcinoma of the liver ECOG PS score of ≤ 2 with a life expectancy of > 3 months > 4 weeks since prior RT or surgery > 1 month post other chemotherapy. Excludes contraindications to angiography and selective visceral catheterization Excludes extra-hepatic disease representing an imminent life-threatening outcome or active infection
Pancreas	Eli Lilly (formerly ARMO Biosciences) J1L-AM-JZGB (formerly AM0010-301) NCT02923921	A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen	Presence of metastatic pancreatic adenocarcinoma Documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan Not received previous radiation therapy or investigational therapy for advanced metastatic disease ECOG performance status 0-1 Complete prior chemotherapy and any investigational therapy at least 2 weeks prior to randomization No peripheral neuropathy No known history of dihydropyrimidine dehydrogenase deficiency Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study

Multiple Myeloma

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
MM, relapsed / refractory	Millennium Pharmaceuticals Inc. C16029 NCT03170882	A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma	Male/female,18 years or older Relapse or PD after having received 2 or more prior lines of systemic therapy. Refractory to lenalidomide, defined as having received at least 2 consecutive cycles Received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen ECOG score 0 - 2 Measurable disease defined by serum M-protein or urine M-protein and documented MM isotype by immunofixation

Lymphoma/Leukemia

Chronic Lymphocytic Leukemia
Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
CLL, PD while on UTX-TGR-304	TG Therapeutics UTX-TGR-204 NCT02656303	A multi-center, open-label, study to evaluate the safety and efficacy of Ublituximab (TG-1101) in combination with TGR-1202 for patients previously enrolled in protocol UTX-TGR-304	ECOG PS ≤ 2 Prior treatment in clinical trial UTX-TGR-304
NHL	TG Therapeutics UTX-TGR-205 NCT02793583	UTX-TGR-205: A Phase 2b Randomized Study To Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with previously Treated Non-Hodgkin's Lymphoma.	Diagnosis of Non-Hodgkin’s Lymphoma (NHL) including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cel transplant ECOG performance status 0 - 2.

GENITOURINARY

Primary Site	Sponsor/Study ID NTC#	Protocol Description	Eligibility
Metastatic CRPC	Clovis Oncology, Inc. CO-338-052 TRITON2 NCT02952534	A Multicenter, Open-label Phase 2 Study of Rucaparib in patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency	Histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of prostate Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency testosterone levels of ≤ 50 ng/dL (1.73 nM) Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration resistant disease
Metastatic CRPC	Clovis Oncology, Inc. CO-338-063 TRITON3 NCT02975934	Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency	ECOG PS: 0 to 1 Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) Have a deleterious mutation in a BRCA1/2 or ATM gene Eligible for treatment with physician’s choice of comparator treatment PD after treatment with one prior next-generation AR-targeted therapy for castration-resistant disease
Renal	Eisai Inc. E7080-G-000-307 NCT02811861	E7080-G-000-307: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR).	Histological or cytological confirmation of RCC with a clear-cell component At least 1 measurable target lesion per RECIST 1.1 KPS of ≥ 70 Adequately controlled BP with or without antihypertensive meds, defined as BP ≤ 150/90 m mHg at screening and no change in antihypertensive meds within 1 week prior to C1D1 Adequate organ function per blood work
Renal Adjuvant monotherapy	Merck MK3475-564 NCT03142334	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)	18 years and older Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features Intermediate-high risk, high risk, or M1 NED RCC as defined per protocol No prior systemic therapy for advanced RCC Undergone a partial nephroprotective or radical complete nephrectomy with negative surgical margins Undergone a nephrectomy and/or metastasectomy ≥28 days before signing consent and ≤12 weeks before randomization Tumor free as assessed by investigator and validated by CT or MRI and bone scan ≤28 before randomization Provided adequate tissue per protocol ECOG PS 0 or 1 Adequate organ function
Bladder	Bristol-Myers Squibb CA209-901 NCT03036098	Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer	Metastatic or inoperable urothelial cancer Must have at least 1 lesion with measurable disease Must have full activity or, if limited, must be able to walk and carry out acivities such as light house work or office work No prior systemic chemotherapy in the metastatic setting.

Lung

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
IIIA, II or IB Resected Non-Squamous NSCLC	NCI A151216 ALCHEMIST NCT02194738	Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) This is the pre-registration study which randomizes to either A081105 or E4512	ECOG PS: 0 or 1 No neoadjuvant (chemo or radio-therapy) for this lung cancer No prior treatment with agents targeting EGFR mutation or ALK rearrangement Pre-surgical: Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm) Post-surgical: Pathologic stage IIIA, II or IB (defined as size ≥4 cm) No recurrence of lung cancer after prior resection
IIIA, II or IB Resected Non-Squamous NSCLC	NCI A081105 ALCHEMIST NCT02193282	Randomized double blind placebo controlled study of erlotinib or placebo in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung center (NSCLC)	ECOG PS: 0 or 1 Registered to A151216 with result of EGFR exon 19 deletion or L858R mutation Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC with negative margins Patients with known resistant mutations in the EGFR TK domain (T790M) are not eligible. Patients that are both EGFR mutant and ALK rearrangements will be registered to A081105
IIIA, II or IB Resected Non-Squamous NSCLC	NCI E4512 ALCHEMIST NCT02201992	A Phase III Double-Blind Trial for Surgically Resecte d Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein	ECOG PS: 0 or 1 Pre-registered to A151216 Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC with negative margins Positive for translocation or inversion events involving the ALK gene locus No prior treatment with crizotinib or another ALK inhibitor No known interstitial fibrosis or interstitial lung disease.
IIIA, II or IB Resected Non-Squamous NSCLC Adjuvant	NCI EA5142 ALCHEMIST NCT02595944	Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) - A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers	Pre-registered to A151216 ECOG PS: 0-1 Completely resected stage IB (≥4 cm), II or IIIA NSCLC with negative margins No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-CTLA4 monoclonal antibody) No known or suspected autoimmune disease No known symptomatic interstitial lung disease
NSCLC Unknown EGFR status	Biodesix BDX-00146 NCT03289780	An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer	18 years of age or older Diagnosis of NSCLC EGFR mutation status wildtype or unknown If prior treatment for local disease, then documented disease progression and treatment completed prior to VeriStrat
Screening for tumor antigen & HLA sub-type in lung cancer	Adaptimmune ADP-0000-001 NCT02636855	A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Solid or Hematological Malignancies	Histologically- or cytologically-confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head & neck, gastric and bladder cancer) Male or female ≥ 18 years of age Life expectancy > 3 months Ability to provide a blood sample Ability to provide one of the following tumor tissue samples: Formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, or fresh biopsy is feasible OR A FFPE archival primary tumor block or tissue sections
Stage IV / Metastatic NSCLC	ARMO Biosciences AM0010-201 (CYPRESS-1) NCT03382899	An Open-label Randomized Phase 2 Trial of AM0010 in Combination with Pembrolizumab vs. Pembrolizumab Alone as First-line Therapy in Patients with Stage IV/Metastatic Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (≥ 50%)	Histologically or cytologically confirmed Stage IV/metastatic NSCLC Naïve to therapy for advanced stage High expression PD-L1 TPS ≥ 50% ECOG performance status of 0 to 1 Measurable disease by CT or MRI Completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization Naïve to therapy for the advanced stage of disease
NSCLC	Heat Biologics HS110-102 NCT02439450	A Phase 1B/2 Study of Viagenpumatucel-L (HS-110) in Combination with Multiple Treatment Regimens in Patients with Non-Small Cell Lung Cancer (The “DURGA” Trial)	Non-small cell lung adenocarcinoma or squamous cell carcinoma At least one site of measurable disease Arm 5: At least one prior line of therapy for incurable or metastatic NSCLC and not progressed; OR Arm 6: Received front line immunotherapy (with or without chemo) for incurable or metaststic NSCLC and not progressed and will begin maintenance immunotherapy with standard of care Pembro ± Pemetrexed. Life expectancy ≥ 18 weeks Arm 5: progression at study entry OR Arm 6: stable disease, partial response, complete response after 9 -12 weeks of front line immunotherapy (with or without chemo) CNS metastases are permitted but must be treated and neurologically stable Arm 5: Suitable for treatment with nivolumab OR Arm 6: Suitable for front line maintenance treatment with Pembro ± Pemetrexed.
Registry	Guardant Health 01-MX-003 (GEODE) NCT03477474	GEODE: Registry of Guardant360® Use and Outcomes In People With Advanced Cancer; Including: Module 1: Non-Small Cell Lung Cancer (NSCLC)	18 years of age and older Ability to provide written informed consent Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment

General Oncology

Primary Site	Sponsor/Study ID NCT #	Protocol Description	Eligibility
Newly diagnosed cancer	LCI Senior Exercise Project/SPP-2014-38-LCI No NCT #	Senior Adult Cancer Treatment Optimization of Performance Project (Pilot study)	70 years or older at time of cancer diagnosis Understand and adhere to study related assessments/procedures No prior cancer treatment Scheduled to start cytotoxic chemotherapy and/or radiation therapy No restriction on tumor stage
High risk Genetics Registry	City of Hope National Medical Center 96144 No NCT # GENETICS STUDY	Molecular Genetic Studies of Cancer Patients and Their Relatives	Personal history or family history of cancer suggestive of presence of an inherited predisposition In a group known or suspected to have increased risk of carrying genetic alteration or of sustaining exposure that would place them at risk of cancer Willing historian to provide information or access Young age cancer diagnosis Multiple primary neoplasms in affected member Presence of rare tumor types in family Congential malformations Any other family clustering of cancer Any other cancer-predisposing genetic disease/conditions
General Oncology: adult solid tumor	Mitra Biotech Inc. MIT-201701 NCT03253575	CANscript™ Clinical OutcomEs in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript™ in Routine Clinical Practice	Male or Female 18 years and older ECOG performance status of ≤2 Patient’s tumor must be amenable to a tumor biopsy sampling, so that CANscript can be performed Patient must have disease that is measurable by standard imaging techniques, per the RECIST 1.1 Histologically- or cytologically-confirmed, locally advanced or metastatic: HNSCC TNBC Stage 3b or 4 NSCLS after failure of appropriate 1st line therapy Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, after failure of 1st line platinum-based chemotherapy Stage IV metastatic CRC

Neuro-Oncology

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Recurrent GBM (Glioblastoma)	ECOG-ACRIN MDNA55-05EAF-151 NCT03115333	Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma	Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery Karnofsky performance status >= 70 Progression of disease assessed by Revised Assessment in Neuro-Oncology (RANO) criteria Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells) Intratumoral hemorrhage as seen MRI may preclude inclusion Progressive enhancement on MRI Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab
Recurrent GBM	Medicenna Therapeutics Inc. MDNA55-05 NCT02858895	An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults with Recurrent or Progressive Glioblastoma	18 years of age and life expectancy ≥ 12 weeks KPS ≥70 Histological confirmed primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) Access to archival tissue from 1^st diagnosis of GBM Recurrent tumor must be suprastentorial, contrast enhancing GB no smaller than 1 x1 cm & no larger than 4 cm max. in a single diameter based on MRI taken within 14 days prior to catheter placement. Able and willing to undergo multiple brain MRI examinations
Anaplastic Glioma or Low Grade Glioma	National Cancer Institute/Alliance N0577 NCT00887146	Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma	ECOG PS: 0, 1 or 2 Newly diagnosed and ≤ 3 months from surgical diagnosis Histological confirmation of anaplastic glioma or low grade glioma Surgery (partial or gross total resection or biopsy) performed ≥ 2 weeks prior to registration with recovering from effects of surgery. Tumor must show 1p/19q codeletion
Meningioma Grade II	National Cancer Institute NRG-BN003 NCT 03180268	Phase III Trial of Observation versus Irradiation for a Gross Totally Resected grade II Meningioma	Newly diagnosed unifocal intracranial meningioma, gross totally resection and histologically confirmed Grade II GTR must be confirmed on post-operative imaging following the most recent surgery Post-operative Zubrod performance status 0-1
Adult Glioma and Meningioma	National Cancer Institute / Moffitt Cancer 15004 No NCT #	Southeastern Study of Cancer and the Environment	Primary diagnosis of glioma or meningioma any grade GBM dx within 1 year, Anaplastic astrocytoma grade III dx within 5 years, grate 2 or less gliomas no restrictions. At least 18 years of age Residents of the US
Brain Tumor Registry	State of Florida NCT00811148	Florida Center for Brain Tumor Research	Adults scheduled to undergo brain surgery to remove tumor tissue
High grade glioma Tissue collection study	Scripps 1R01CA229737-07 No NCT #	Clinical Translation of Precision Medicine Testing Utilizing 3 Dimensional Primary Tumor Cell Culture	Patients scheduled to have surgery for removal of brain tumor. Age: 18 years and older.
Leptomeningeal disease registry	Penn State Registry No NCT #	NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults	Adults 18 years and older diagnosed and treated with neoplastic meningitis.