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NIZ985 + Spartalizumab for Solid Cancers
Study Summary
This trial is testing a new drug to see if it is safe and works well with other cancer treatments. They will also study how the body processes the drug.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are able to perform daily activities without being limited by your health, and the doctor thinks you can complete at least 28 days of treatment.You have a heart problem that affects your health.You have another type of cancer that is getting worse or needs treatment.You are taking high doses of steroids or other medications that weaken your immune system, except for replacement steroids for adrenal insufficiency, within 7 days of starting the study treatment.You have an active HIV, HBV, or HCV infection.You have a serious infection that needs strong antibiotics.You currently have an autoimmune disease that is known or suspected.You have received radiation therapy within 2 weeks before starting the study drug.You have been treated with certain types of immunotherapy in the past, and it worked for a while but then stopped working.You have had a specific type of skin cancer called melanoma, and have been treated with certain medications in the past that target the immune system, and your cancer responded and then started growing again.You have advanced solid tumors or lymphoma that have not responded to standard treatments, and there are no other suitable treatments available.You have advanced lung cancer that cannot be removed with surgery and have received up to two previous treatments, one of which was a type of immunotherapy.You need to have a place where a small piece of your tumor can be removed for testing, and your doctor must agree that it's safe for you to have this procedure.You have or had a serious lung disease.You have experienced severe side effects from previous cancer treatment, except for nerve damage, hearing problems, and hair loss.You have used certain medications to help with blood counts or have had a blood transfusion within 2 weeks before starting the study treatment.You have been treated with IL-15 before.You have had a serious allergic reaction to any ingredient in the study drug or similar medications.You have a brain tumor.Your disease must be able to be measured using specific guidelines.
- Group 1: Arm 1
- Group 2: Arm 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the intended outcome of this investigation?
"The objective of this 24 month long experiment is to observe the safety, tolerability and potential side effects of NIZ985 when administered as a single agent or in combination with Spartalizumab. Secondary endpoints include Progression Free Survival (PFS) for expansion group patients, Disease Control Rate (DCR), and prevalence/incidence measurements of Immunogenicity related to NIZ985, spartalizumab, or tislelizumab through serum antidrug antibody testing at baseline and during treatment."
Is NIZ985 a safe and efficacious option for treating patients?
"As this is an early Phase 1 trial, the data on NIZ985's safety and efficacy was insufficient for our team at Power to assign it a score higher than 1."
How extensive is the enrollment for this medical research?
"Indeed, the clinicaltrials.gov page indicates that this research project is currently seeking participants; it was initially advertised on February 27th 2020 and updated most recently November 30th 2022. 110 people are required across 3 sites."
What other data have been collected regarding NIZ985's usage?
"Research on the potential medical applications of NIZ985 began at UCLA School of Medicine back in 2011, with 30 experiments having been concluded thus far. Currently, there are 27 active trials occurring around the world; many taking place within Duarte, Texas."
Are there any recruitment opportunities with this experiment presently?
"Affirmative. Information listed on clinicaltrials.gov confirms that this trial, which was inaugurated on February 27th 2020, is actively soliciting participants. Approximately 110 enrollees are needed from 3 distinct medical facilities."
Is this a freshly-inaugurated medical experiment?
"NIZ985 has been under clinical study since 2011, when Novartis Pharmaceuticals sponsored its initial trial of 185 patients. Subsequent to the Phase 1 drug approval in 2011, 27 active experiments are being conducted for NIZ985 spanning 122 cities and 35 nations worldwide."
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