Purpose The NCI Surgery Branch has developed an experimental therapy for treating patients with metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-mesothelin incorporated in the retrovirus.
Clinical Trials
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab in Refractory Cancer
Purpose: The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab.
A Study of ABBV-181 in Participants With Advanced Solid Tumors
Purpose: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-181. The study will consist of 2 parts: ABBV-181 dose escalation and ABBV-181 dose expansion.
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Purpose: In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors that have progressed on standard of care therapy will be treated with pembrolizumab.
Phase IB of Selinexor in Combination With Standard Chemotherapy in Patients With Advanced Malignancies
Purpose: Primary Objective: To establish the safety and tolerability of Selinexor when given in combination with standard chemotherapy regimens.
Secondary Objectives:To determine disease control and progression free survival of Selinexor administered with standard chemotherapy treatments.
Exploratory Objectives:To determine the correlation of translational biomarkers To compare serial assessment of mutation status in biopsies obtained at baseline and progression after clinical response to combination therapy
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Purpose: This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Purpose: To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
Safety and Effect of GL-ONC1 Administered IV With or Without Eculizumab Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery
Purpose: The purpose of this study is to evaluate the safety of the investigational product GL-ONC1 in combination with eculizumab. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide. Eculizumab is a type of drug called a monoclonal antibody. This drug is designed to inhibit the activity of a protein called complement. Complement is part of the body’s immune system that destroys and removes foreign particles. Evidence from laboratory tests suggest eculizumab may allow GL-ONC1 to stay in the body longer before being cleared by the immune system, which may help destroy more cancer cells.
Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
Purpose:Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Purpose: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.
