Durvalumab + Tremelimumab for Pediatric Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study treatment until death or up to approximately 4 years (clinical dco of 20 apr 2023)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the recommended dose of two immunotherapy drugs, durvalumab and tremelimumab, in pediatric patients with advanced cancers. If the dose is effective, the drugs' efficacy will be tested in a second phase.

Who is the study for?

This trial is for children up to 17 years old with advanced solid tumors or blood cancers like Non-Hodgkin's Lymphoma, who have not responded to standard treatments and have no other treatment options. They must have a life expectancy of at least 3 months, adequate organ function, and no prior immune therapy.

What is being tested?

The study aims to find the right dose of durvalumab and tremelimumab (immunotherapy drugs) for pediatric patients with certain cancers. After determining the dose, they'll test how effective these drugs are in treating these conditions.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells in various organs, infusion-related reactions similar to allergic responses, fatigue, potential infections due to lowered immunity among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study treatment until death or up to approximately 4 years (clinical dco of 20 apr 2023)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study treatment until death or up to approximately 4 years (clinical dco of 20 apr 2023)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment until death or up to approximately 4 years (clinical dco of 20 apr 2023) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-Expansion Phase Only: Best Objective Response (BOR)

Dose-Expansion Phase Only: Disease Control Rate (DCR)

Dose-Expansion Phase Only: Duration of Response (DOR)

+23 more

Secondary study objectives

Dose-Expansion Phase: AUC (0-14) of Durvalumab

Dose-Expansion Phase: AUC (0-14) of Tremelimumab

Dose-Expansion Phase: AUC (0-14)/D of Durvalumab

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab / Tremelimumab Combination TherapyExperimental Treatment1 Intervention

Part 1 (dose finding) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are initially administered at dose level 1 and dose escalated based on results from PK modeling and tolerance to determine the RP2D. Both drugs are administered every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvavalumab for 4 doses, from cycles 2-5. (sarcoma, NB and NHL) Part 2 (dose expansion phase) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are administered at the RP2D, every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvalumab for 4 doses, from cycles 1-4. Tremelimumab may be added for 4 doses at time of progressive disease. Cohorts: solid tumors, sarcomas, NHL restricted to PMBCL and ALCL subtypes)

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