19 studies found

A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast...

Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.

Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring

Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

Many antiretroviral therapy (ART) medications given to a pregnant woman cross the placenta and can be detected in the amniotic fluid and cord blood resulting in substantial fetal exposure. Therefore, there is concern about toxicity of the drugs in the fetus and infant. It is noteworthy that none of the...

Savolitinib in Treating Participants With MET Amplified Metastatic or Unresectable Colorectal Cancer

PRIMARY OBJECTIVES: I. To estimate the objective response rate (ORR) of savolitinib in patients with MET amplified metastatic colorectal cancer (CRC). SECONDARY OBJECTIVES: I. To describe the clinical activity (duration of response, progression free survival [PFS]) of savolitinib in patients with MET amplified metastatic CRC. II. To describe the toxicities...

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

PRIMARY OBJECTIVE: I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma. SECONDARY OBJECTIVES: I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard...

Phase 1b Study to Evaluate ATP128, With or Without BI 754091, in Patients With Stage IV Colorectal Cancer

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients...

PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody...

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

OBJECTIVES: Primary Phase II - Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. - Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. Phase III * Compare overall survival rates among patients...

Phase 1 / 2 Study of AGEN2034 in Advanced Tumors and Cervical Cancer

This is a Phase 1, open-label, 3 + 3 dose-escalation trial in subjects with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum doublet.

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma

PRIMARY OBJECTIVES: I. Determine the dose of anetumab ravtansine that is safe in combination with MK-3475 (pembrolizumab) to be used in the randomized phase 2 study. (Phase I safety lead-in) II. Determine if the overall response rate of the combination of anetumab ravtansine and MK-3475 (pembrolizumab) is superior to MK-3475...

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed...

Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

- Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks). - Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR]...

Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Study of LN-145 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a NMA...

Photohandler

Phase II Randomized Double-Blind Trial of PF-04518600, an OX40 Antibody, in Combination with Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients with Metastatic Renal Cell Carcinoma

Patients with the most common type of kidney cancer are initially treated with VEGF targeting drugs such as sunitinib and pazopanib, among others. Once the cancer develops resistance, the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as nivolumab. Unfortunately, no treatment strategy works forever and inevitably...

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced...

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

PRIMARY OBJECTIVES: I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with...