52 studies found

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

PRIMARY OBJECTIVES: I. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (Phase II) II. To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab. (Phase III) SECONDARY OBJECTIVES: I. To compare progression free...

⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy as Single Agent...

De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

PRIMARY OBJECTIVES: I. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) II. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority...

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...

Norris ORIEN Total Cancer Care

PRIMARY OBJECTIVES: I. To establish a longitudinal study of clinical and related data from patients with or at risk for cancer. II. To establish a large biospecimen repository that is linked to clinical and related data. III. To follow patients through their lifetime though passive or active follow-up. IV. To...

Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

PRIMARY OBJECTIVES: I. To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability. II. To test the hypothesis that changes in the...

Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers

PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory agents, cellular therapies, stem cell transplantation) and compare to changes in patients receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification, functional analysis...

MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer

PRIMARY OBJECTIVES: I. To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant bladder cancer in patients. II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3 groups...

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...

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...

Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients

PRIMARY OBJECTIVES: I. To document the appearance of androgen receptor isoform splice variant 7 (AR-V7) expression over the course of therapy in castration-resistant prostate cancer (CRPC). II. To determine whether detectable AR-V7 is associated with a shortened duration of treatment benefit of abiraterone or enzalutamide. SECONDARY OBJECTIVES: I. To determine...

Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

PRIMARY OBJECTIVES: I. To evaluate a novel clinical assay (Myeloid Derived Suppressor Cells [MDSC] Clinical Assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant renal cell carcinoma in patients. II. Determine mean MDSC level, intra-subject variability, and...

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

PRIMARY OBJECTIVES: I. To compare the overall survival (OS) in molecularly selected patients with metastatic colorectal cancer (CRC) receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). SECONDARY OBJECTIVES: I. To compare the progression free survival (PFS) in molecularly selected patients with metastatic CRC receiving panitumumab rechallenge versus standard therapy...

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer...

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R)...

Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

This study will determine if the combination of regorafenib and pembrolizumab is safe and tolerated in patients with advanced liver cancer. In addition, the study will explore the anti-tumor activity of this combination as well as potentially identifying blood and tissue biomarkers associated with disease activity, status or response. The...

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

PRIMARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision...

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show...

Study of GNX102 in Patients With Advanced Solid Tumors

GNX102 is a humanized monoclonal antibody (mAb) developed by GlycoNex. GNX102 binds with high affinity to branched Lewis B/Lewis Y (LeB/LeY) glycans, which are novel glycans caused by glycosylation changes in tumors. The monomeric LeB and LeY are blood group related antigens, commonly present in healthy adult tissues at low...

Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Adults With Advanced Cancers

Participants found to be human leukocyte antigen (HLA)-DPB1*04:01 positive and whose tumors are MAGE-A3 and/or MAGE-A6 positive can participate if all eligibility criteria are met. Other tests required to determine eligibility include a physical exam, electrocardiogram (ECG) and echocardiogram (ECHO) of the heart, CT or MRI scans, and blood draws....

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

PRIMARY OBJECTIVE: I. To determine whether atezolizumab combined with oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX) and its continuation as monotherapy can significantly improve disease-free survival (DFS) compared to FOLFOX alone in patients with stage III colon cancers and deficient DNA mismatch repair (dMMR). SECONDARY OBJECTIVES: I. To determine whether atezolizumab...

Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

PRIMARY OBJECTIVES: I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies. II. To facilitate clinically annotated genomic analyses. OUTLINE: Patients submit blood samples for genetic testing.

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

PRIMARY OBJECTIVE: I. To compare event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant MK-3475 (pembrolizumab) with patients randomized to adjuvant MK-3475 (pembrolizumab). SECONDARY OBJECTIVES: I. To assess the frequency and severity of toxicities on each of the arms. II. To compare between arms overall survival (OS),...

Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

PRIMARY OBJECTIVE: I. To evaluate the objective response rate (confirmed complete and partial responses) 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 talimogene laherparepvec (T-VEC). SECONDARY OBJECTIVES: I. To estimate...