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Neoplasms clinical trials

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NCT ID: NCT04294576 Active, not recruiting - Clinical trials for Locally Advanced/Metastatic Solid Tumors

Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

FIH
Start date: December 4, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab in adult patients with Locally Advanced/Metastatic Solid Tumors

NCT ID: NCT04287868 Active, not recruiting - Cervical Cancer Clinical Trials

Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Start date: June 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; cyclin-dependent kinase inhibitor 2A (P16+) oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers Design: Participants will be screened with: - medical history - disease confirmation (or tumor biopsy) - physical exam - body scans (computed tomography (CT), magnetic resonance imaging (MRI), and/or nuclear) - blood tests - electrocardiogram (to measure the electrical activity of the heart) - urine tests. Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses. Participants will get M7824 (MSB0011395C) by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period. Participants will get NHS-IL12 injected under the skin every 4 weeks. Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study. About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life. Patients with cervical cancer with prior pelvic radiation and boost brachytherapy will be enrolled in a separate cohort to evaluate safety and preliminary evidence of efficacy...

NCT ID: NCT04285996 Active, not recruiting - Cancer Clinical Trials

IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types

IMPACT
Start date: March 2016
Phase: N/A
Study type: Interventional

A substance called integrin alpha v beta six (αvβ6) is found to be increased in some cancer cells and can play an important role in the development and spread of cancer. If the levels of integrin αvβ6 in cancer cells can be measured by carrying out PET scans, we might be able to identify and potentially treat tumours. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to find and measure the amount of integrin αvβ6 in tumours. To do this a small amount of radioactivity will be attached to FBA-A20FMDV2 and carry out a scan called a Positron Emission Tomography (PET) scan. FBA-A20FMDV2 attached to radioactivity is known as [18F]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer dose is given to humans. So far such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF). This was to assess the safety of the radiotracer and how it is taken up in the body. However, such scans have not been performed in cancer patients. This study will help specifically investigate αvβ6 in patients with cancer and find out how [18F]FBA-A20FMDV2 is taken up in tumours. With this information, the ideal imaging method for patients with cancer can be developed.

NCT ID: NCT04284774 Active, not recruiting - Clinical trials for Malignant Solid Neoplasm

Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

Start date: October 13, 2020
Phase: Phase 2
Study type: Interventional

This phase II pediatric MATCH trial studies how well tipifarnib works in treating patients with solid tumors that have recurred or spread to other places in the body (advanced), lymphoma, or histiocytic disorders, that have a genetic alteration in the gene HRAS. Tipifarnib may block the growth of cancer cells that have specific genetic changes in a gene called HRAS and may reduce tumor size.

NCT ID: NCT04283994 Active, not recruiting - Quality of Life Clinical Trials

Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)

PICSI-H
Start date: July 26, 2021
Phase: N/A
Study type: Interventional

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the Survey-based Patient/Clinician Jumpstart compared to the EHR based clinician Jumpstart and usual care for improving quality of care; the primary outcome is EHR documentation of a goals-of-care discussion from randomization through hospitalization or 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital length of stay, costs of care during the hospitalization, 7 and 30 day readmission); and b) patient- and family-reported outcomes assessed by surveys at 3 days and 4 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

NCT ID: NCT04281667 Active, not recruiting - Colorectal Cancer Clinical Trials

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

MOBILE2
Start date: March 18, 2020
Phase: Phase 4
Study type: Interventional

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

NCT ID: NCT04280133 Active, not recruiting - Clinical trials for Hematologic Malignancy

CAR T-CELL Therapy Educational Video Trial

Start date: May 25, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer. - Educational video tool for patients receiving CAR-T cell therapy.

NCT ID: NCT04272034 Active, not recruiting - Cervical Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Start date: March 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

NCT ID: NCT04270864 Active, not recruiting - Advanced Cancer Clinical Trials

Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers

PRIMO
Start date: April 10, 2020
Phase: Phase 1
Study type: Interventional

Open label, phase Ib study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab. The trial will be divided into two parts: PART A: the first part will assess the safety of two regimen and will recruit patients with all types of injectable solid malignancies PART B: the second part will include 3 expansion cohorts of 15 patients: - B1: anti-PD-1 refractory advanced NSCLC cohort - B2: anti-PD-1 refractory advanced melanoma cohort - B3: immunotherapy naïve microsatellite stable colorectal cancer (MSS CRC) cohort

NCT ID: NCT04267861 Active, not recruiting - Neoplasms Clinical Trials

M7824 Related Adverse Effects in Adults With Cancer

Start date: January 28, 2020
Phase:
Study type: Observational

Background: Immunotherapy drugs use a person s own immune system to help fight cancer. These drugs work better for some people than others. The drug M7824 has helped some people with cancer. But it can cause side effects. Researchers want to learn all the side effects that M7824 can cause. Once they do, they can prevent or reduce these side effects in future cancer treatments. This will lead to better overall outcomes for people with cancer. Objective: To make a thorough list of adverse events in people with cancer being treated with systemic therapies including M7824 at the National Cancer Institute (NCI). Eligibility: Participants previously enrolled in NCI protocols #15-C-0179 and #18-C-0056 Design: All needed data have already been collected. These data are stored in existing records and databases. Researchers will review the medical records of adults with cancer who were enrolled in the above protocols. The data collected will be relevant to the specific objectives being addressed. Data will be collected only if 2 conditions are met. One, the principal investigator gave permission for use of the data gathered in the trial. Two, the participants of the trial did not opt out of future use of the data. Other protocols may be added. This will be done with an amendment. ...