Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With … (NCT04751383) | Clinical Trial Compass
CompletedPhase 1
Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma
United States, Canada12 participantsStarted 2021-08-31
Plain-language summary
This phase I trial is to find out the best dose, possible benefits and/or side effects of magrolimab in combination with dinutuximab in treating patients with neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) or relapsed osteosarcoma. Magrolimab and dinutuximab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. The combination of magrolimab and dinutuximab may shrink or stabilize relapsed or refractory neuroblastoma or relapsed osteosarcoma. In addition, this trial may help researchers find out if it is safe to give magrolimab and dinutuximab after surgery to remove tumors from the lungs.
Who can participate
Age range
2 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a history of histologically or cytologically confirmed NBL or osteosarcoma
* Patients must have:
* Relapsed/refractory high-risk neuroblastoma (NBL) (defined as disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction therapy) or
* Relapsed osteosarcoma (relapsed after frontline therapy and/or there must not be any potentially curative treatment options available at the time of enrollment)
* Cohort B1: Confirmed neuroblastoma: measurable NBL/ganglioneuroblastoma (defined as those lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with cross sectional imaging (CT scan or MRI), or \>= 10 mm with calipers by clinical exam). Chest x-ray cannot be used to determine eligibility. Lesions must be iobenguane (MIBG) positive, positron emission tomography (PET) avid (if patient has a history MIBG negative disease) or biopsy proven NBL/ganglioneuroblastoma
* Cohort B2: Evaluable NBL (MIBG and/or bone marrow disease only)
* Cohort B3: Measurable osteosarcoma (defined as those lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm (\>= 1 cm) with cross sectional imaging (CT scan, MRI, or calipers by clinical exam). Chest x-ray cannot be used to determine eligibility
* Cohort B4: Patients with relapsed resectable pulmonary osteosarcoma who are scheduled for a surgic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent (95% CI) of Participants With Grade 3 or Higher Adverse Events (Dose Finding Cohort)
Timeframe: Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days)
2
Cycle 1 Dose Limiting Toxicities of Magrolimab
Timeframe: During cycle 1 (21 days)
3
Percent (95% CI) of Participants With Grade 3 or Higher Adverse Events (Expansion Cohort)