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Tazemetostat + Immunotherapy for Cancer
Study Summary
This trial is testing a combination of three drugs to see if they are effective in treating tumors that are lacking in one of two proteins.
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 2 trial • 20 Patients • NCT03456726Trial Design
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Who is running the clinical trial?
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- My brain tumor lacks certain proteins (INI1 or SMARCA4).I am mostly able to care for myself and carry out daily activities.I have not received a live vaccine in the last 30 days.I agree to use birth control for 5 months after my last dose of treatment.Your cancer diagnosis has been confirmed by examining tissue samples under a microscope.My tumor lacks INI1 or SMARCA4, confirmed by tests.I finished my initial cancer treatment less than 8 weeks ago.I am between 6 months and 21 years old.You are expected to live for at least 2 more months.I have finished my initial treatment plan for my condition.I have recovered from side effects of my previous cancer treatments.I agree to use barrier contraception for 3 months after my last dose of treatment.My heart, liver, kidneys, lungs, and brain are working well.Women who could become pregnant must have a negative pregnancy test.I can understand and agree to the study's procedures and risks.I am not taking any experimental drugs or strong medications that affect liver enzymes.I have had or currently have lung inflammation treated with steroids.Depending on which group you are in, you need to have either a specific type of disease that can be measured or evaluated, or no signs of the disease according to medical tests.You have had allergic reactions to drugs similar to tazemetostat or Orasweet.Your blood test should not show any unusual cell shapes that could indicate certain blood disorders.I have been treated with specific immune therapy drugs before.My cancer is one of the specific types listed, like MRT or RTK.I have never had myeloid malignancies, MDS, LBL, or ALL.I have an autoimmune disease that needed treatment in the last year.I have a history of HIV, hepatitis B, or hepatitis C.
- Group 1: EXP B1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B1)
- Group 2: EXP A3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A3)
- Group 3: EXP B2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B2)
- Group 4: EXP A2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A2)
- Group 5: EXP B3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B3)
- Group 6: Phase I a: DOSE ESCALATION (STRATUM A, ATRT and primary CNS malignant tumor, INI/SMARCA4-deficient)
- Group 7: Phase I b: DOSE ESCALATION (STRATUM B, NON-ATRT, NON-CNS)
- Group 8: EXP A1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A1)
- 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
Who is eligible to sign up for this medical experiment?
"The specific recruitment criteria for this trial is as follows: individuals aged between 6 months and 21 years with a diagnosis of chordoma, atypical teratoid rhabdoid tumor (ATRT), stratum A; other INI1- or SMARCA4-deficient primary CNS malignant tumors (with PI approval), stratum B; malignant rhabdoid tumor (MRT); Rhabdoid tumor of the kidney (RTK); epithelioid sarcoma; poorly differentiated or de-differentiated chordoma, and other INI1- or SMARCA4 deficient malignant tumors"
Are there any openings for volunteers to participate in this trial?
"Per the listing on clinicaltrials.gov, this particular trial is not taking in participants at present. It was initially posted on December 1st 2022 and last updated on October 27th 2022; however, there are currently 2903 other trials that are actively recruiting patients to take part."
Does this trial include applicants who are over the age of 35?
"This clinical trial is seeking applicants aged 6 Months to 21; 431 studies are available for minors, and 2665 studies have been conducted on individuals over 65."
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