185 studies found
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A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)

The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass...

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A pilot study of safety and efficacy of spectroscopic diagnosis of pancreatic lesions (Spy Panc)

The objective of this study is to determine if a minimally invasive optical probe can accurately predict a histological diagnosis of dysplastic or malignant tumor cells in solid lesions of the pancreas. If effective, this optical probe would facilitate the detection of malignant and pre-malignant pancreatic lesions. This would lead...

A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma

This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer. Eligible patients will be enrolled into the study and administered sodium cridanimod in...

Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)

This is a Phase 2, open-label,multi-center, multicohort study of intratumoral tilsotolimod in combination with nivolumab and ipilimumab for the treatment of specific solid tumors

0C-14-7: A Phase 1/2A, Multicenter, Open-Label Study of Oral RxDx-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations

RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor. The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response...

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Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)

The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs...

7H-14-1 An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Head and neck carcinomas (HNC) describe cancers of the upper digestive tract which include squamous cell cancers (SCCHN) of the mouth, throat, and vocal chords. At present, there is no effective standard of care that provides survival benefits beyond 4 - 6 months in second line treatment of SCCHN that...

Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma

This is a randomized, multicenter phase II study of pembrolizumab in combination with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival rate....

AZD1775 Plus Chemotherapy in Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

This is a phase II study of AZD1775 plus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive AZD1775 plus carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary endpoint for the study is overall response rate (ORR) defined as the proportion...

2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma

This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel...

An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)

VTI-212 is an open-label, multicenter, historically-controlled study of subjects with acute liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the study will receive ELAD treatment in addition to standard of care treatment for ALF. The outcomes of these subjects will be compared with matched historical controls...

A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)

The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in combination with EP for 6 cycles followed a Phase 2, multicenter, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to...

18F-FMAU PET/CT in Imaging Patients With Advanced Cancers

PRIMARY OBJECTIVES: I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and characterize the incidence of circulating metabolites of 18F-FMAU in humans. II. To simply find out whether there is any visual uptake...

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response...

FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy

PRIMARY OBJECTIVES: I. To determine the negative predictive value (NPV) of [18F]fluoroestradiol (FES) uptake for response (clinical benefit) at 6 months in patients with estrogen-receptor positive (ER+) metastatic breast cancer treated with first-line endocrine therapy. SECONDARY OBJECTIVES: I. To determine the test-retest reproducibility of quantitative assessment of tumor FES uptake...

Anti-CD137 Monoclonal Antibody in Patients With Advanced Cancer

This Phase 1 study will enroll up to approximately 86 evaluable adult subjects with refractory cancer (solid tumors) regardless of diagnosis. Subjects may be enrolled into the following cohorts: The trial will consist of a 3+3 dose escalation that will evaluate different combination dose levels of AGEN2373 monotherapy and in...

Actuate 1901: 9-ING-41 in Myelofibrosis

9-ING-41 is a first-in-class, intravenously administered, maleimide-based, small molecule, potent selective GSK-3β inhibitor with significant pre-clinical and clinical anticancer activity. In the ongoing Actuate 1801 study in a cohort of over 90 patients with advanced refractory malignancies, 9-ING-41 has exhibited no significant toxicity, including no myelosuppression, and significant anti-tumor activity....

SWOG S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To compare cognitive failure free survival (CFFS) rate up to...

Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

PRIMARY OBJECTIVES: I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known. II. Compare the sensitivity of digital droplet...

Fluid Biopsy for the Diagnosis of Lung Cancer

PRIMARY OBJECTIVE: I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma. SECONDARY OBJECTIVES: I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer. II. To determine the relative contribution of cell based high definition circulating tumor...

Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

PRIMARY OBJECTIVES: I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting. II. Optimize data analysis methods and software usage to create a metabolic profile for...

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation. No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and Radiation therapy Oncology Group (RTOG) (NSABP B-39 and RTOG 0413)...

Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

PRIMARY OBJECTIVE: I. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC). SECONDARY OBJECTIVES: I. To compare overall survival between the two arms. II. To compare modified bladder intact event-free survival including cancer related death between...

AFPᶜ³³²T in Advanced HCC

This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The...

Study to Assess AFM24 in Advanced Solid Cancers

There will be two parts to this study: a dose escalation phase (1) and a dose expansion phase (2a). The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD) and establish the recommended Phase 2a dose (RP2D). The dose escalation phase will be followed by...