Active — Not RecruitingPhase 1/2

Durvalumab and Tremelimumab for Pediatric Malignancies

United States, France, Germany50 participantsStarted 2019-03-07

Plain-language summary

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

Who can participate

Age range

0 Years – 18 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: * Max Age =17 years * Solid Tumors (except primary central nervous system malignant tumors): Patients must have a histopathologic confirmation of malignancy. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist * Non-Hodgkin's Lymphoma, limited to primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist. * Provision of diagnostic tumor sample mandated if available * Evaluable disease * No prior exposure to immune-mediated therapy * Adequate organ and marrow function * Life expectancy of at least 3 months Exclusion Criteria: * History of allogeneic organ transplantation (exceptions may be allowed for NHL after discussion with Sponsor). History of autologous bone marrow transplant may be allowed (after discussion with Sponsor). * Active or prior documented autoimmune or inflammatory disorders (exceptions) * Uncontrolled intercurrent illness * History of primary immunodeficiency * Active infection including tuberculosis, hepatitis B, C or HIV * Any unresolved toxicity NCI CTCAE version 5.0 Grade ≥2 from previous anticancer therapy (exceptions)

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.

1Since this trial is no longer enrolling new patients, can you tell me whether there are any related or follow-up studies testing durvalumab or tremelimumab in children with my child's specific type of cancer that we could still consider?
2This trial has both a dose-finding phase and a dose-expansion phase — do you know which phase produced results relevant to my child's diagnosis, and what the safety data on adverse events looked like for pediatric patients receiving this combination?
3Because this is a Phase 1/2 study focused partly on how these drugs behave in children's bodies, how does the level of evidence from this type of trial compare to what we'd expect from an approved standard treatment for my child's cancer?
4The trial tracked serious side effects specifically for this drug combination — given that both durvalumab and tremelimumab affect the immune system, what kinds of immune-related complications should we be watching for, and how would those be managed in a child?
5For the expansion phase, they were measuring response rates and survival outcomes — has enough data been published or shared from this trial for you to tell me whether the results looked promising for my child's type of tumor or blood cancer?

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

Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

Dose-Finding Phase: Minimum Serum Concentration (Cmin) of Durvalumab

Dose-Finding Phase: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Dose-Finding Phase: Time to Cmax (Tmax) of Durvalumab

Trial details

NCT IDNCT03837899

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

Results submitted2023-11-16

View on ClinicalTrials.gov More Pediatric Cancer trials