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Study Title Principal Investigator
Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma
Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.
Not recruiting | Skin Cancer | Multisite
Robert Dillman
Not recruiting | Gynecologic Cancers | Multisite
Antoni Ribas
Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
PRIMARY OBJECTIVES: I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma. II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique. SECONDARY OBJECTIVES: I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease. OUTLINE: Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB). After completion of study treatment, patients are followed up at 24 and 48 hours.
Open | Skin Cancer | Not Multisite
Kevin King
A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin
Not recruiting | Neuroendocrine Tumors | Multisite
Novartis Pharmaceuticals
A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
Terminated | Skin Cancer | Multisite
Bristol-Myers Squibb
A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors
PRIMARY OBJECTIVES: I. Determine the dose limiting toxicity (DLT) and recommended phase II dose (RP2D) of the combination of cabozantinib (cabozantinib-s-malate) and nivolumab (cabo-nivo) and separately the combination of cabozantinib, nivolumab and ipilimumab (cabo-nivo-ipi) in patients with genitourinary tumors. (Phase I) II. Assess safety and tolerability of cabozantinib, nivolumab and ipilimumab (cabo-nivo-ipi) in patients with genitourinary tumors at this novel dose. (Dose Level 8 Cohort) SECONDARY OBJECTIVES: I. Preliminarily evaluate the activity, as determined by objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and the modified Immune-Related Response Criteria (irRC), derived from RECIST1.1, of cabo-nivo and cabo-nivo-ipi in patients with advanced/refractory metastatic urothelial carcinoma (checkpoint inhibition therapy naive) and with renal cell carcinoma in the second-line and beyond setting. II. Preliminarily evaluate the activity, as determined by objective response rate using RECIST 1.1 and the modified irRC, derived from RECIST 1.1, of cabo-nivo in patients with adenocarcinoma and with rare histologies (including squamous or small cell carcinomas of the bladder, renal medullary carcinoma, sarcomatoid bladder and renal cell carcinomas, plasmacytoid carcinoma of the bladder and others) in the first line or beyond setting. III. Preliminarily evaluate the activity, as determined by objective response rate using RECIST 1.1 and the modified irRC, derived from RECIST 1.1, of cabo-nivo in patients with urothelial carcinoma previously treated with checkpoint inhibition therapy in the second line or beyond setting. IV. Preliminarily evaluate the activity, as determined by objective response rate using RECIST 1.1 and the modified irRC, derived from RECIST 1.1, of cabo-nivo-ipi in patients with squamous cell carcinoma of the penis. V. To evaluate the activity as determined by progression free survival (PFS) and overall survival (OS) of: cabo-nivo and cabo-nivo-ipi in patients with advanced/refractory metastatic urothelial carcinoma (checkpoint inhibition therapy naive) or with renal cell carcinoma in the second-line and beyond setting. VI. To evaluate the activity as determined by PFS and OS of: cabo-nivo in patients with advanced adenocarcinoma and with rare histologies (including squamous or small cell carcinomas of the bladder, renal medullary carcinoma, sarcomatoid bladder and renal cell carcinomas, plasmacytoid carcinoma of the bladder and others) in the first-line and beyond setting. VII. To evaluate the activity as determined by PFS and OS of: cabo-nivo in patients with urothelial carcinoma previously treated with checkpoint inhibition therapy in the second line or beyond setting. VIII. To evaluate the activity as determined by PFS and OS of: cabo-nivo-ipi in patients with squamous cell carcinoma of the penis. IX. To obtain additional data to evaluate the safety of both combinations in patients with clear cell renal cell carcinoma (ccRCC). X. To assess the number of malignant soft tissue and bone lesions on fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) (scan 1) versus combined fluorine F 18 sodium fluoride (18F-NaF) and 18F-FDG PET/CT (scan 2). XI. To assess response assessment by RECIST 1.1 using CT of the chest, abdomen, and pelvis with intravenous (IV) contrast versus assessment by combined 18F-NaF and 18F-FDG PET/CT (scan 2) using number of malignant and change (modified PET RECIST [PERCIST]) of soft tissue and bone lesions. XII. To test the feasibility of automated density and volume application (ADaVA) as a means of assessing tumor response. XIII. To assess PDL-1 and MET expression data and in exploratory fashion analyze their association to response or clinical benefit. TERTIARY OBJECTIVES: I. To assess overall response rates (ORR) on patients who have been challenged or re-challenged with ipilimumab therapy post disease progression. II. To assess effects of treatment in patients with bone-only disease. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment arms. PART I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 21 courses, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. After progression, patients may receive cabozantinib-s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for 4 courses followed by cabozantinib-s-malate PO QD and nivolumab IV every 2 weeks or 4 weeks if post-course 21 in the absence of disease progression or unacceptable toxicity. PART II: Patients receive cabozantinib-s-malate PO QD on days 1-21, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses with ipilimumab, patients continue receiving cabozantinib-s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 21 courses in the absence of disease progression or unacceptable toxicity. After 21 courses, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. After progression, patients may receive cabozantinib-s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for 4 courses followed by cabozantinib-s-malate PO QD and nivolumab IV every 2 weeks or 4 weeks if post-course 21 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 16 weeks or 100 days and then every 2 months thereafter.
Open | Kidney Cancer | Multisite
Andrea Apolo
Not recruiting | Skin Cancer | Site Unknown
James Hu
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An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Open | Brain Cancer | Multisite
Clinical Trials
Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)
Not recruiting | Skin Cancer | Site Unknown
Medical Director
Prospective Randomized Phase II Trial of Pazopanib (NSC # 737754) Versus Placebo in Patients With Progressive Carcinoid Tumors
PRIMARY OBJECTIVES: I. For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) will be compared between patients randomized to treatment with pazopanib (pazopanib hydrochloride) versus placebo. SECONDARY OBJECTIVES: I. Overall survival (OS) will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms. III. Progression free survival (PFS) as assessed by central radiology review and local radiology review will be compared overall and within treatment arms. IV. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm. V. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo. VI. To determine the turn-around time for timely adjudicated central review. VII. To characterize the nature of discordance between local and central radiology review in assessment of progression. VIII. To characterize the type and rate of progression in carcinoid (at study entry, on-study, and at progression). IX. To develop new methods for modeling carcinoid growth and detecting treatment effects, and to perform simulations that advance new clinical trial designs to apply to future trials of carcinoid therapeutics. X. To assess for differences in quality of life (QOL)-related domains between the two treatment groups (pazopanib versus placebo). XI. To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (European Organization for Research and Treatment of Cancer [EORTC], neuroendocrine tumors [NET]21). XII. To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms. XIII. To determine whether components of the plasma angiome panel that have been shown to be predictive previously (interleukin-6 [IL-6] and vascular endothelial growth factor [VEGF]-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202. XIV. To determine whether other components of the plasma angiome panel tested (not IL-6 and VEGF-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202. XV. To evaluate the changes in the plasma angiome markers after treatment with or without pazopanib over time. EXPLORATORY OBJECTIVES: I. PFS at 6 months will be estimated within each treatment arm. II. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. After completion of study treatment, patients are followed up every 3-6 months for 5 years.
Not recruiting | Neuroendocrine Tumors | Multisite
Emily Bergsland
A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. SECONDARY OBJECTIVES: I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. III. To evaluate the toxicity associated with temozolomide alone or temozolomide and capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors. IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic neuroendocrine tumor patients treated with either temozolomide or temozolomide and capecitabine. V. To bank radiology images for evaluation of quality, reproducibility, and compliance with computed tomography (CT) methodology. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Not recruiting | Neuroendocrine Tumors | Multisite
Pamela Kunz
A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Not recruiting | Skin Cancer | Multisite
Array BioPharma
A Phase II Study of Combining Talimogene Laherparepvec T-VEC (NSC-785349) and MK-3475 (Pembrolizumab) (NSC-776864) in Patients With Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy
PRIMARY OBJECTIVES: I. To evaluate the durable response rate of treatment with talimogene laherparepvec (T-VEC) in combination with MK-3475 (pembrolizumab) following progression on prior anti-PD-1 or anti-PD-L1 therapy alone or in combination with other agents different from T-VEC. SECONDARY OBJECTIVES: I. To estimate the objective response rate (confirmed and unconfirmed, complete and partial responses) in the injected lesions. II. To estimate the objective response rate (ORR) in the non-visceral, non-injected lesions. III. To estimate the objective response rate (ORR) in the visceral lesions (Cohort A). IV. To estimate the overall objective response rate (ORR). V. To estimate the median progression-free survival (PFS). VI. To estimate the median overall survival (OS). VII. To evaluate the toxicity of the regimen. TERTIARY OBJECTIVES: I. To evaluate whether adding T-VEC to PD1 blockade can increase T-cell infiltration into tumors and whether change in T-cell infiltration is associated with response. II. To evaluate whether adding T-VEC to PD1 blockade can increase T-cell receptor (TCR) clonality in tumors and in peripheral blood and whether increased TCR clonality is associated with response. III. To evaluate whether intra-tumoral injection of T-VEC is associated with the tumor immune microenvironment. IV. To evaluate whether tumor mutational load and mutations in the IFN pathway is associated with response to T-VEC plus MK-3475 (pembrolizumab) therapy in the anti-PD1/L1 therapy refractory melanoma patients. OUTLINE: Patients receive talimogene laherparepvec intralesionally (IL) and pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 courses for talimogene laherparepvec and 36 courses for pembrolizumab in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years and then annually for a total of 5 years.
Open | Skin Cancer | Multisite
Siwen Hu-Lieskovan
A Phase II and Pilot Trial of PD-1 Blockade With MK-3475 (Pembrolizumab) in Patients With Resectable or Unresectable Desmoplastic Melanoma (DM)
PRIMARY OBJECTIVES: I. To evaluate the pathologic complete response rate (pCR) in patients with resectable desmoplastic melanoma treated with neoadjuvant MK-3475 (pembrolizumab). (Cohort A) II. To evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable desmoplastic melanoma treated with MK-3475 (pembrolizumab). (Cohort B) SECONDARY OBJECTIVES: I. To estimate the 9 week response rate (RR) (unconfirmed complete and partial responses) among patients with measurable disease. (Cohort A) II. To estimate the median overall survival (OS). (Cohort A) III. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in the neoadjuvant setting. (Cohort A) IV. To estimate the median progression-free survival (PFS). (Cohort B) V. To estimate the median overall survival (OS). (Cohort B) VI. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in this setting. (Cohort B) TERTIARY OBJECTIVES: I. To evaluate the hypothesis that higher mutational load in the patient derived baseline tumor biopsy samples is associated with higher pathologic complete response (pCR). II. To evaluate T cell infiltration into the tumors in DM patients and correlate with response to programmed cell death protein 1 (PD-1) blockade. III. To evaluate the clonality of tumor infiltrating T cells in DM patients and correlate with response to PD-1 blockade. IV. To evaluate adaptive immune resistant mechanism in DM tumors. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses. Patients with potentially resectable disease undergo surgery. Patients with tumor progression and unresectable disease may receive one additional course of pembrolizumab. COHORT B: Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or toxicity. After completion of study treatment, patients are followed up at 6 and 12 weeks, then every 3 months for 1 year, and every 6 months for 4 years.
Open | Skin Cancer | Multisite
Kari Kendra
Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors
PRIMARY OBJECTIVES: I. To assess progression-free survival (PFS) in advanced/metastatic in patients with carcinoid or pancreatic islet cell tumors. SECONDARY OBJECTIVES: I. To assess overall survival and response rate in advanced/metastatic poor prognosis in patients with carcinoid or pancreatic islet cell tumors. II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors. OUTLINE: Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Open | Neuroendocrine Tumors | Multisite
Syma Iqbal
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