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TNO155 + Spartalizumab/Ribociclib for Cancer
Study Summary
This trial is testing a new drug, TNO155, in combination with two other drugs, spartalizumab or ribociclib, to see if it is safe and effective in treating advanced solid tumors. The study will enroll subjects in two groups to compare the safety, tolerability, and preliminary effectiveness of the two combinations. Treatment will continue until the subject experiences unacceptable toxicity, disease progression, or treatment is discontinued at the discretion of the Investigator or the subject, or the subject withdraws consent.
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- Your bone marrow doesn't work properly.You have a condition like ulcerative colitis or Crohn's disease that affects your digestive system and may impact how the study drugs are absorbed in your body.You are taking any medication that can make your heart's QT interval longer, unless you can stop taking it for the entire study.You have a history of or are currently at risk for a type of eye condition called retinal vein occlusion.You have unstable brain metastases causing neurological symptoms.Your liver or kidney function is not good enough when tested before the study.You stopped a previous treatment because of side effects related to anti-PD-1 therapy.You have advanced solid tumors that can be measured using certain guidelines, and you fit into specific groups for different parts of the study.You are able to perform daily activities without being restricted by your health condition.I'm sorry, but I need more specific details about the exclusion criteria for the TNO155 plus spartalizumab combination in order to provide a simple summary.I'm happy to help! Here's a simplified version of the exclusion criteria for the TNO155 plus ribociclib combination:
You cannot participate if you have certain medical conditions or are taking certain medications that could affect the study.You have been treated with a specific type of medication that targets the MAPK pathway before.You have a serious heart condition or risk factors for heart problems.You must have a place in your body where a small sample of tissue can be taken for testing.If you have a specific type of lung cancer and there's a treatment available for it in your area, you must have tried it before joining the study.
- Group 1: TNO155 in combination with spartalizumab
- Group 2: TNO155 in combination with ribociclib
- 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 effects is the research team hoping to observe with this trial?
"This 3 year investigation aims to measure the impacts of dose interruptions, reductions and intensity on treatment efficacy. Additionally, overall survival (OS) will be tracked along with Cmax for TNO155, spartalizumab, and ribociclib as well as progression-free survival (PFS) per RECIST v1.1 by treatment."
Is this experiment the first of its kind?
"Since 2011, research has been conducted on TNO155. Initial trial data was sponsored by Novartis in that same year and involved 185 patients; this led to the drug's Phase 1 approval. At present, hundreds of cities spanning 50 countries are conducting 72 active studies concerning TNO155."
What is the scope of enrollment for this research?
"Affirmative. According to the clinicaltrials.gov records, this investigation is actively recruiting participants after first being posted on July 30th 2019 and last modified on November 28th 2022. 185 people are needed from a single research centre for this venture."
Has the Food and Drug Administration given its blessing to TNO155?
"Due to the limited extant data surrounding TNO155's efficacy and safety, this drug received a score of 1 on our team at Power’s rating scale."
Are there any unfilled positions in this research project?
"Affirmative. According to clinicaltrials.gov, this study is currently open for enrollment and was initially posted on July 30th 2019 with the most recent update happening on November 28th 2022. 185 participants are needed from a single research centre."
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