Comparing Paxalisib with Opdualag for childhood cancer
Official title: Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
- Phase 1
- 2 groups
- Sites in Edmonton, Montreal and 3 more cities
- Recruiting
Interventions (4)
- Medication
Paxalisib
Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
- Medication
Opdualag
Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
- Medication
Irinotecan (drug)
Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
- Medication
Temozolomide (TMZ)
Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.
Canadian Sites (5)
3 of 5 recruiting
- Recruiting
CHU Sainte Justine
Montreal
- Recruiting
The Hospital for Sick Children
Toronto
- Recruiting
BC Children's Hospital
Vancouver
- Not yet recruiting
Stollery Children's Hospital
Edmonton
- Not yet recruiting
Children's Hospital of Eastern Ontario
Ottawa
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists.
- +Age \<21 years at inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent/refractory malignancy.
- +Patients must be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).
- +Patients enrolled in a Phase IPhase 1The earliest stage of human testing, in a small group, focused on safety.Read more → cohortCohortA group of participants sharing a characteristic, followed together.Read more → must have either evaluable or measurable disease.
- +Patients enrolled in a Phase IIPhase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type.
- +Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → may be undertaken at the patient's local oncology treatment centre with results transferred to study siteTrial siteA hospital or clinic where a study is actually run.Read more → for evaluation.
- +Performance status: Karnofsky performance status (for patients \> 16 years of age) or Lansky play score (for patients ≤ 16 years of age) ≥ 50%.
- +Life expectancy ≥ 6 weeks.
- +Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment.
- +Adequate organ function.
- +Able to comply with scheduled follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → and with management of toxicity.
- +Provide a signed and dated informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Females of childbearing potential must have a negative serum or urine pregnancy test.
- +Fertile males must agree to use adequate contraception during the study and following completion of treatment.
Exclusion
- −Known hypersensitivity to any study drug or component of the formulation.
- −Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- −Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to controlControl groupThe group a new treatment is measured against.Read more → their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.
- −Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) - only for armsArmOne of the groups in a study, each receiving something different.Read more → that include orally administered therapeutic agents.
- −Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would either compromise patient safety or interfere with the evaluation of the safety of the investigational drug(s).
- −Pregnant or nursing (lactating) females.
- −Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Paxalisib, together with one or more of: Irinotecan (drug) and Temozolomide (TMZ).
Registry label: A: Arm A Paxalisib
Group B receives Opdualag.
Registry label: B: Arm C Opdualag
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 0 years to 21 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 90 people.
The study is currently expected to finish around December 2035.
The main measurement is taken over: 5 Years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants treated with molecularly-targeted agents in each treatment armArmOne of the groups in a study, each receiving something different.Read more → — measured over 5 Years.
Recommended phase IIPhase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → dose for each treatment arm — measured over 3 Years.
Objective Response Rate (ORR) for each treatment arm — measured over 5 Years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06208657 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PaxalisibDrug
Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OpdualagDrug
Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Irinotecan (drug)Drug
Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Temozolomide (TMZ)Drug
Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 0 years to 21 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 0 years to 21 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 Years.
The study as a whole is currently expected to finish around 2035-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 90 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Edmonton, Canada; Montreal, Canada; Ottawa, Canada; Toronto, Canada; Vancouver, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A companion platform trial to test novel targeted agents based on the patient's tumor profile.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.