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Neoplasm clinical trials

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NCT ID: NCT03637764 Terminated - Neoplasm Clinical Trials

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Start date: August 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D). - Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC. - Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM. Secondary Objectives: - To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2. - To evaluate the immunogenicity of isatuximab and atezolizumab. - To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab. - To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).

NCT ID: NCT03547037 Completed - Neoplasm Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers

Start date: August 31, 2018
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).

NCT ID: NCT03415126 Completed - Cancer Clinical Trials

A Study of ASN007 in Patients With Advanced Solid Tumors

Start date: January 19, 2018
Phase: Phase 1
Study type: Interventional

The study is divided into two parts. The first part of the study will test various doses of ASN007 to find out the highest safe dose to test in five specific groups. The second part of the study will test how well ASN007 can control cancer.

NCT ID: NCT03251924 Terminated - Cancer Clinical Trials

A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Start date: September 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

NCT ID: NCT03099161 Terminated - Neoplasm Clinical Trials

Study of Preladenant (MK-3814) Alone and With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3814A-062)

Start date: June 27, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and preliminary efficacy of preladenant (MK-3814A) alone and in combination with pembrolizumab (MK-3475) (pembro) in participants with advanced solid tumors that have not responded to prior therapy. This study will be done in 2 parts. Part 1 will identify and confirm the recommended Phase 2 dose (RP2D) of preladenant when given alone or in combination with pembrolizumab. Part 2 of the study will determine the safety and efficacy of preladenant in combination with pembrolizumab at the RP2D in participants with select solid tumors .

NCT ID: NCT02955446 No longer available - Neoplasm Clinical Trials

Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

Start date: n/a
Phase:
Study type: Expanded Access

This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.

NCT ID: NCT02925234 Recruiting - Cancer Clinical Trials

The Drug Rediscovery Protocol (DRUP Trial)

DRUP
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.

NCT ID: NCT02875327 Completed - Neoplasm Clinical Trials

Linkage of Medicaid Enrollment Information to Surveillance, Epidemiology and End Results Data

Start date: August 5, 2016
Phase:
Study type: Observational

Background: The SEER database collects data about people with cancer. SEER stands for Surveillance, Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who have low income or serious medical needs. Many studies have shown that Medicaid recipients with cancer are more likely to be diagnosed later in the disease than people with other insurance. They are also less likely to get treatment. Researchers want to compare Medicaid data and SEER data. They want to make this available to other scientists. Objectives: To link people in the SEER database to Medicaid data for the years around their cancer diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers. Eligibility: No people are enrolled in this study. Design: The SEER finder file will be securely uploaded to the CMS Data Center. The finder file will be matched against the Medicaid Personal Summary file at the CMS Data Center. If participants appear in both the SEER file and Medicaid file, their data will be extracted. The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will see if the Medicaid dates fall in certain periods. These are 12 months before, the month of, and 11 months after diagnosis. If participants are eligible for Medicaid for these periods, a flag will be created in the file. It will note the participants is eligible and why. The SEER finder file will be destroyed. The only data saved will be: Each participant's unique random SEER case number linked to their Medicaid number Monthly flags about Medicaid eligibility

NCT ID: NCT02851706 Active, not recruiting - Brain Tumor Clinical Trials

Natural History of and Specimen Banking for People With Tumors of the Central Nervous System

Start date: September 1, 2016
Phase:
Study type: Observational

Background: Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths in the U.S. in children and adults. Little progress has been made in treating brain tumors. Researchers want to learn more about these tumors by studying people who have them. Objectives: To understand brain and spinal cord tumors better and uncover areas for further research. Also, to connect people with these tumors to doctors who can help them manage their illness and give them new treatment options. Design: Participants will have an initial (baseline) visit. They will have their medical history taken and undergo physical and neurological exams. They will have blood tests. They may have scans (imaging studies) of the nervous system. If participants have urine or cerebrospinal fluid collected during their regular care, researchers may save some. Brain tumor tissue from a prior surgery may be studied. Genomic DNA testing will be done on samples. Results will be linked to participants medical and/or family history. The number of study visits at NIH will depend on the wishes of participants and their local doctors. Participants will take a brain tumor survey on a computer. They can take it all at once or in 6 separate sections. Participants will answer questions about their general well-being. They will answer questions to learn if they have symptoms of depression or anxiety. Physicians will discuss test results with participants. They will recommend management and treatment options.

NCT ID: NCT02828449 Recruiting - Neoplasm Clinical Trials

Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

CHIMIO ORALE
Start date: November 2016
Phase: N/A
Study type: Interventional

Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions. The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year: 1. Assess the achievement of the target population 2. Evaluate the adaptation of intervention in context 3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention. 4. Assessing the sustainability of the intervention