← Back to Search

Checkpoint Inhibitor

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,595,186 Total Patients Enrolled

Ashok Gupta, MD, PhDStudy DirectorAstraZeneca Global Medicines Development, Academy House

Media Library

Durvalumab / Tremelimumab Combination Therapy (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03837899 — Phase 1 & 2

Pediatric Cancer Research Study Groups: Durvalumab / Tremelimumab Combination Therapy

Pediatric Cancer Clinical Trial 2023: Durvalumab / Tremelimumab Combination Therapy Highlights & Side Effects. Trial Name: NCT03837899 — Phase 1 & 2

Durvalumab / Tremelimumab Combination Therapy (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03837899 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies does Durvalumab / Tremelimumab Combination Therapy typically address?

"Durvalumab / Tremelimumab Combination Therapy is conventionally used to treat unresectable stage iii non-small cell lung cancer, but can also be leveraged in advanced cases of metastatic ureter urothelial carcinoma and other conditions."

Answered by AI

Has this specific clinical trial been attempted previously?

"Durvalumab / Tremelimumab Combination Therapy was first trialled in 2007, when AstraZeneca sponsored a 37-person study. Subsequently gaining Phase 2 approval from the FDA, it has since been administered to 340 people across 1327 cities and 58 nations."

Answered by AI

Are there any current opportunities to enroll in this experiment?

"As evidenced on the clinicaltrials.gov platform, this trial is not currently recruiting participants. The study was initially published on March 7th 2019 and has since been updated for the final time on November 3rd 2022. Despite that, there are 2912 other medical trials actively enrolling patients at this moment in time."

Answered by AI

Is the age requirement for this medical experiment eighteen years or older?

"This medical trial is searching for patients aged 0 to 18 years of age."

Answered by AI

Who is an eligible participant for this research endeavor?

"This research is recruiting fifty minors aged 0 to 18 with a pediatric cancer, who must meet the following conditions: Maximum Age of 17 years old; histologically confirmed solid tumors (except for primary central nervous system malignant tumors); progression or refractory status towards conventional therapies and treatments absent in standard care practices; non-Hodgkin's lymphoma limited to primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma; evaluable disease; lack of exposure to immune mediated therapy priorly, and an expected life span exceeding three months."

Answered by AI

What is the population size for this clinical investigation?

"This medical trial has closed its recruitment and was last edited on November 3, 2022. However, there are currently 2572 trials searching for patients with pediatric cancer and 340 studies looking to recruit participants for Durvalumab / Tremelimumab Combination Therapy."

Answered by AI

Are there any prior research studies available regarding the efficacy of Durvalumab/Tremelimumab Combination Therapy?

"Currently, there are 340 trials running for Durvalumab / Tremelimumab Combination Therapy. Of those, 52 have entered the third phase of clinical testing. Although most studies take place in Cordoba, Texas, they span 13083 locations around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and Tremelimumab for Pediatric Malignancies

2019. "Durvalumab and Tremelimumab for Pediatric Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03837899.

All > Pediatric Cancer