BREAST. POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non- Interventional Study

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1 BREAST Advanced breast Cancer, metastatic breast cancer Radiation Oncology Pfizer A NCT NCI Alliance A NCT POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non- Interventional Study Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (BWELL) 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 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 Page 1 of 13

2 Recurrent or metastatic breast cancer Breast Cancer: Gene expression profiling Daehwa 107CS-6 (OPERA) NCT Agendia FLEX Registry NCT 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 MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry) 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) 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 No Stage 0 disease GASTROINTESTINAL 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 Page 2 of 13

3 Pancreas Eli Lilly (formerly ARMO Biosciences) J1L-AM-JZGB (formerly AM ) NCT Lynn Cancer Institute Oncology Trials 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 HEMATOLOGY 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 MM, relapsed / refractory Millennium Pharmaceuticals C16029 NCT ANEMIA MULTIPLE MYELOMA 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 bortezomibor carfilzomib-containing regimen ECOG score 0 2 Measurable disease defined by serum M-protein or urine M-protein and documented MM isotype by immunofixation Page 3 of 13

4 LYMPHOMA/LEUKEMIA CHRONIC LYMPHOCYTIC LEUKEMIA CLL, PD while on UTX-TGR- 304 NHL TG Therapeutics UTX-TGR-204 NCT TG Therapeutics UTX-TGR-205 NCT A multi-center, open-label, study to evaluate the safety and efficacy of Ublituximab (TG-1101) in combination with TGR for patients previously enrolled in protocol UTX-TGR- 304 UTX-TGR-205: A Phase 2b Randomized Study To Assess the Efficacy and Safety of the Combination of Ublituximab + TGR with or without Bendamustine and TGR-1202 alone in Patients with previously Treated Non-Hodgkin's Lymphoma. ECOG PS 2 Prior treatment in clinical trial UTX-TGR-304 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 cell transplant ECOG performance status 0-2. General Oncology Newly diagnosed cancer LCI Senior Exercise Project/ SPP LCI No 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 Page 4 of 13

5 High risk Genetics Registry General Oncology: adult solid tumor City of Hope National Medical Center No GENETICS STUDY Mitra Biotech Inc. MIT NCT Molecular Genetic Studies of Cancer Patients and Their Relatives 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 LUNG 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 Congenital malformations Any other family clustering of cancer Any other cancer-predisposing genetic disease/conditions 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: o HNSCC o TNBC o Stage 3b or 4 NSCLS after failure of appropriate 1 st line therapy o Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, after failure of 1 st line platinum-based chemotherapy o Stage IV metastatic CRC Page 5 of 13

6 IIIA, II or IB Resected Non- Squamous IIIA, II or IB Resected Non- Squamous NCI A ALCHEMIST NCT NCI A ALCHEMIST NCT Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) This is the pre-registration study which randomizes to either A or E4512 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 () 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 ECOG PS: 0 or 1 Registered to A with result of EGFR exon 19 deletion or L858R mutation Completely resected stage IB ( 4cm), II, or IIIA nonsquamous 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 A IIIA, II or IB Resected Non- Squamous NCI E4512 ALCHEMIST NCT A Phase III Double-Blind Trial for Surgically Resected 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 A Completely resected stage IB ( 4cm), II, or IIIA nonsquamous 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. Page 6 of 13

7 IIIA, II or IB Resected Non- Squamous Adjuvant Unknown EGFR status Advanced ALK positive Screening for tumor antigen & HLA subtype in lung cancer NCI EA5142 ALCHEMIST NCT Biodesix BDX NCT Pfizer B NCT Adaptimmune ADP NCT 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 An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer A Phase 3, Randomized, Open-Label Study of Lorlatinib (PF ) Monotherapy Versus Crizotinib Monotherapy in the First-Line Treatment of Patients with Advanced ALK-Positive Non-Small Cell Lung Cancer A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Solid or Hematological Malignancies Pre-registered to A ECOG PS: 0-1 Completely resected stage IB ( 4 cm), II or IIIA 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 18 years of age or older Diagnosis of EGFR mutation status wildtype or unknown If prior treatment for local disease, then documented disease progression and treatment completed prior to VeriStrat Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK positive Archival FFPE tissue block must be available. No prior systemic treatment. ECOG performance status 0-2 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,, 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: o Formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, or fresh biopsy is feasible OR o A FFPE archival primary tumor block or tissue sections Page 7 of 13

8 Stage IV / Metastatic ARMO Biosciences AM (CYPRESS-1) NCT Tesaro NCT 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%) Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination with a PD-1 Inhibitor in Patients with Non-Small Cell Lung Cancer GENITOURINARY Histologically or cytologically confirmed Stage IV/metastatic 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 Histological or cytological proven advanced (unresectable) or metastatic stage IIIB or stage IV Cohorts 1A/2A (combo niraparib/pd-1 inhibitor): must have tumors with high PD-L1 expression (TPS 50%) per local assessment, with no known EGFR-sensitizing mutation and/or ROS-1 or ALK translocation, and no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment for metastatic Metastatic CRPC Clovis Oncology, Inc. CO TRITON2 NCT 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 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 Page 8 of 13

9 Metastatic CRPC Metastatic CRPC Renal Clovis Oncology, Inc. CO TRITON3 NCT F. Hoffman-La Roche Ltd CO39303 NCT Eisai Inc. E7080-G NCT 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 A phase III, randomized, double-blind, placebo-controlled, multicenter trial testing Ipatasertib plus Abiraterone plus prednisone/prednisolone, relative to placebo plus Abiraterone plus prednisone/prednisolone in patients with asymptomatic or mildly symptomatic, metastatic castrate resistant prostate cancer with PTEN diagnostic positive tumors E7080-G : 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). ECOG PS: 0 or 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 ARtargeted therapy for castration-resistant disease Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features Consent to provide FFPE tissue block Valid PTEN IHC result (central testing) Metastatic disease documented by bone lesion on bone scan or soft tissue disease by CT or MRI Asymptomatic or mildly symptomatic form of prostate cancer Progress disease before initiating study treatment Ongoing androgen deprivation with GnRH analog or bilateral orchiectomy 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 mmhg at screening and no change in antihypertensive meds within 1 week prior to C1D1 Adequate organ function per blood work Page 9 of 13

10 Renal Adjuvant monotherapy Bladder Merck MK NCT Bristol-Myers Squibb CA NCT 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) 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 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 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 activities such as light house work or office work No prior systemic chemotherapy in the metastatic setting. Head and Neck Neurology and Neuro-Oncology Page 10 of 13

11 Neurology and Neuro-Oncology Recurrent GBM (Glioblastoma) Newly diagnosed GBM (Glioblastoma) ECOG-ACRIN EAF-151 NCT Nativis NAT-109 NCT Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma A Feasibility Study of the Nativis Voyager System in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) 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 KPS >or=60 Pathological evidence of GBM Maximal debulking surgery. May enroll if received Gliadel wafers before entering trial. At least 1 measurable lesion by RANO At least 18 years of age Life expectancy of > 3 months Adequate organ and marrow function Able to start treatment at least 28 days from tumor resection surgery Page 11 of 13

12 Neurology and Neuro-Oncology Recurrent GBM Recurrent GBM Anaplastic Glioma or Low Grade Glioma Meningioma Grade II Medicenna Therapeutics Inc. MDNA55-05 NCT Nativis, Inc. NAT-101 NCT National Cancer Institute/Alliance N0577 NCT National Cancer Institute NRG-BN003 NCT An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults with Recurrent or Progressive Glioblastoma A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM) 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 Phase III Trial of Observation versus Irradiation for a Gross Totally Resected grade II Meningioma 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 KPS 60 Histologically confirmed diagnosis of GBM Failed or intolerant to radiotherapy and temozolomide therapy Progressive disease with at least 1 measurable lesion on MRI 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 and recovered from effects of surgery. Tumor must show 1p/19q codeletion 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 Page 12 of 13

13 Neurology and Neuro-Oncology Adult Glioma and Meningioma Brain Tumor Brain Tumor Registry High grade glioma Tissue collection study Leptomeningeal disease registry National Cancer Institute /Moffitt Cancer No NCI A NCT State of Florida NCT Scripps 1R01CA No Penn State Registry Southeastern Study of Cancer and the Environment A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil ) To Reduce Cancer Related Fatigue in Patients With High Grade Glioma Florida Center for Brain Tumor Research Clinical Translation of Precision Medicine Testing Utilizing 3 Dimensional Primary Tumor Cell Culture NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults 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 ECOG of 0, 1, 2,or 3 Diagnosed with GBM, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma who are clinically stable & have completed radiation therapy Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care Stable dose of corticosteroid > or = 14 days prior registration Adults scheduled to undergo brain surgery to remove tumor tissue Patients scheduled to have surgery for removal of brain tumor. Age: 18 years and older. Adults 18 years and older diagnosed and treated with neoplastic meningitis. No Page 13 of 13