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Checkpoint Inhibitor
Tazemetostat + Immunotherapy for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Susan Chi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status ≥ 50% for subjects ≥16 years of age and Lansky performance status ≥ 50% for subjects <16 years of age
All subjects must have had tumor assessment at original diagnosis or relapse showing either of the following: Loss of INI1 confirmed by immunohistochemistry (IHC) OR molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable, Loss of SMARCA4 confirmed by IHC OR molecular confirmation of tumor SMARCA4 loss or mutation (with PI approval)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment duration is a median of n cycles range (t1 - t2). treatment continues until disease progression or unacceptable toxicity up to 5.5 years
Awards & highlights
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.
Who is the study for?
This trial is for young patients aged 6 months to 21 years with specific tumors lacking INI1 or SMARCA4 proteins. Eligible participants must have completed prior treatments, be in good health otherwise, and agree to contraception if applicable. Those with uncontrolled illnesses, organ transplants, pregnancy, certain infections like HIV or hepatitis B/C, autoimmune diseases requiring treatment within the past year, or a history of allergic reactions to similar compounds are excluded.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Tazemetostat (TAZVERIK), Nivolumab (OPDIVO), and Ipilimumab (YERVOY) as potential treatments for malignant rhabdoid tumor and other related conditions that lack INI1/SMARCA4 proteins. The effectiveness of this drug trio will be evaluated on different patient groups based on their disease status.See study design
What are the potential side effects?
Potential side effects may include immune-related issues due to Nivolumab and Ipilimumab's action on the immune system; these can range from inflammation in various organs to skin reactions. Tazemetostat could cause blood disorders or fatigue. Specific side effects depend on individual responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
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My tumor lacks INI1 or SMARCA4, confirmed by tests.
Select...
I am between 6 months and 21 years old.
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I can understand and agree to the study's procedures and risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment duration is a median of n cycles range (t1 - t2). treatment continues until disease progression or unacceptable toxicity up to 5.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment duration is a median of n cycles range (t1 - t2). treatment continues until disease progression or unacceptable toxicity up to 5.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Maximal Tolerated Dose (MTD)
Secondary outcome measures
Median Overall Survival (OS)
Median Progression-free survival (PFS)
Overall Response Rate (ORR)
+1 moreSide effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Weight decreased
18%
Blood creatinine increased
18%
Thrombocytopenia
18%
Neutropenia
18%
Nausea
12%
Urinary tract infection
12%
Pneumonia
12%
Amylase increased
12%
Herpes simplex
12%
Influenza
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Musculoskeletal chest pain
6%
Hypogammaglobulinaemia
6%
Gastric cancer
6%
Oedema peripheral
6%
Fatigue
6%
Blood zinc decreased
6%
Traumatic fracture
6%
Non-small cell lung cancer
6%
Myalgia
6%
Gastroenteritis
6%
Immature granulocyte count increased
6%
Skin exfoliation
6%
Electrocardiogram QT prolonged
6%
Haematochezia
6%
Pyrexia
6%
Aspartate aminotransferase increased
6%
Osteonecrosis of jaw
6%
Nail disorder
6%
Abdominal pain
6%
Bronchitis
6%
Pneumocystis jirovecii pneumonia
6%
Large intestine polyp
6%
Haematuria
6%
Visual field defect
6%
Insomnia
6%
Phlebitis
6%
Upper respiratory tract inflammation
6%
Tooth disorder
6%
Impetigo
6%
Hypertonic bladder
6%
Rash maculo-papular
6%
Blood pressure decreased
6%
Traumatic intracranial haemorrhage
6%
Gamma-glutamyltransferase increased
6%
Hypoalbuminaemia
6%
Alanine aminotransferase increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
Trial Design
8Treatment groups
Experimental Treatment
Group I: Phase I b: DOSE ESCALATION (STRATUM B, NON-ATRT, NON-CNS)Experimental Treatment3 Interventions
Part 1 will be two concurrent "rolling six" phase 1 studies starting at a different tazemetostat dose for each stratum), with one dose escalation and one dose de-escalation planned. All subjects will receive the same nivolumab and ipilimumab doses and dosing schedule
Group II: Phase I a: DOSE ESCALATION (STRATUM A, ATRT and primary CNS malignant tumor, INI/SMARCA4-deficient)Experimental Treatment3 Interventions
Part 1 will be two concurrent "rolling six" phase 1 studies starting at a different tazemetostat dose for each stratum), with one dose escalation and one dose de-escalation planned. All subjects will receive the same nivolumab and ipilimumab doses and dosing schedule
Group III: EXP B3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B3)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Group IV: EXP B2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B2)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Group V: EXP B1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B1)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Group VI: EXP A3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A3)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Group VII: EXP A2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A2)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Group VIII: EXP A1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A1)Experimental Treatment3 Interventions
Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2.
Part 2 will consist of 3 substrata per stratum based on their disease status
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Tazemetostat
2016
Completed Phase 2
~1050
Find a Location
Who is running the clinical trial?
Susan ChiLead Sponsor
Susan Chi, MDLead Sponsor
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,874 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: EXP B1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B1)
- Group 2: EXP B3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B3)
- Group 3: EXP A1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A1)
- Group 4: Phase I b: DOSE ESCALATION (STRATUM B, NON-ATRT, NON-CNS)
- Group 5: EXP A2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A2)
- Group 6: EXP A3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A3)
- Group 7: EXP B2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B2)
- Group 8: Phase I a: DOSE ESCALATION (STRATUM A, ATRT and primary CNS malignant tumor, INI/SMARCA4-deficient)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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"
Answered by AI
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."
Answered by AI
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."
Answered by AI
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