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Duvelisib + Nivolumab for Skin Cancer
Study Summary
This trial is testing a new combination therapy to treat mycosis fungoides and Sezary syndrome, which are skin cancers. The new therapy consists of two drugs, duvelisib and nivolumab. Duvelisib works by stopping the growth of tumor cells, and nivolumab helps the body's immune system attack the cancer. The trial is testing whether this new combination therapy is more effective than the usual approach.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT02004522Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Is this research project open for recruitment at the present time?
"Affirmative. According to clinicaltrials.gov, this study is open for recruitment and was posted on May 3rd 2021. The last update took place November 1st 2022 and the trial seeks 24 people from 11 sites across the country."
What effects have been noted from the use of Duvelisib?
"Due to the limited amount of clinical data that exist for Duvelisib, our team at Power assigned it a safety rating of 1. This is in line with its Phase 1 trial designation, which implies sparse information about both efficacy and security."
Could you tell me about any prior investigations conducted with Duvelisib?
"Duvelisib's initial research began at Local Institution in 2012, and since then 267 studies have been completed. There are currently 730 active trials taking place with a large number of these based out of Jacksonville, Florida."
Which diseases does Duvelisib typically alleviate?
"Duvelisib is mainly used to treat metastatic ureter urothelial carcinoma, but it can also be employed for conditions like metastatic hepatocellular carcinoma and malignant melanoma of skin in cases where two prior treatments have failed."
Are there extensive deployments of this research in the US?
"Participants for this trial are being enrolled from 11 different medical centres, which includes Jacksonville, Rochester and Creve Coeur. To lessen the burden of travel, it is best to choose the closest site possible when enrolling in the study."
What is the scope of involvement in this experiment?
"Affirmative. Clinicaltrials.gov reports that this trial is still in the recruitment stage, which began on May 3rd 2021 and was last updated November 1st 2022. 24 participants must be enrolled from 11 distinct sites to complete the study's requirements."
What is the main purpose of this investigation?
"The primary purpose of this 28 day cycle trial is to measure the occurrence of adverse events. Secondary objectives include assessing Disease Control Rate (DCR) via a sample proportion and confidence interval, Overall Response Rate (ORR) by sampling proportions with 95% confidence intervals per Agresti-Coull methods, as well as Duration of Response (DoR) for responding patients through Kaplan-Meier analysis using Global Response Criteria adapted for cutaneous T-cell lymphoma comprising skin evaluation based on modified severity-weighted assessment tool, flow cytometry study into Sezary cells in peripheral blood circulation, and radiographic examination employing contrast"
Does this research mark a pioneering effort in its field?
"Presently, there are 730 live trials of Duvelisib underway in 2361 cities across 49 nations. First tested on 659 participants in 2012 by Ono Pharmaceutical Co. Ltd., the drug successfully completed its Phase 1 & 2 clinical trial stages and has since had 267 further studies conducted upon it."
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