trialsTrialActive

Durvalumab and Tremelimumab for Pediatric Malignancies

A phase 1/2 trial of Durvalumab and Tremelimumab in childhood cancers, run by AstraZeneca, active and no longer recruiting.

Durvalumab and Tremelimumab for Pediatric Malignancies is a phase 1/2 interventional study registered as NCT03837899 by AstraZeneca, with 50 participants enrolled, started 2019-03-07 and due to reach its primary completion in 2023-02-28. Interventions recorded: Durvalumab / Tremelimumab Combination Therapy. Results have been posted on the registry.

Setting

Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies.

Phase

Phase 1/2

Sponsor

AstraZeneca

Registry

Started

2019-03-07

Reported

2024

Enrolled

50 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

50 enrolled

Dose-Expansion Phase Only: Objective Response Rate (ORR)primaryresponse endpoint

0 vs 11.1 out of 100 had their tumour shrink with SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg compared with STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg; 11.1 fewer per 100.
On this measure the first group did worse, not better.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

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

Median 10.8 months with STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg.
A median is a midpoint: half the people did better than this and half did worse.

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.

Dose-Expansion Phase Only: PFSprimarysurrogate endpoint

Median 1.7 vs 1.7 months with SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg compared with STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg; about 0 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies. People in a different situation may not see the same effect.
Only 50 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

50 enrolled.

Dose-Expansion Phase Only: Objective Response Rate (ORR)primary

SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg0 of 100

n = 11

STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg11.1 of 100

n = 9

Download

Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication

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

Download

range 10.8 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication

Dose-Expansion Phase Only: PFSprimary

Download

90% CI 1.58 to 1.91; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication · 90% CI 0.89 to 2.76

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Dose-Expansion Phase Only: Objective Response Rate (ORR)primary	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	11	0%	-	-	link
	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	9	11.1%	-	-	link
Dose-Expansion Phase Only: Duration of Response (DOR)primary	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	1	10.8 months	-	-	link
Dose-Expansion Phase Only: PFSprimary	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	11	1.7 months	-	-	link
Dose-Expansion Phase Only: PFSprimary	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	10	1.7 months	-	-	link

Connected

Similar pages

Trial
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Shares Tremelimumab, Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
Shares Tremelimumab, Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Shares Tremelimumab, Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
Shares Tremelimumab, Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Trial
Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.

cancers

Childhood cancers (all types)

technologies

Immune checkpoint inhibitors

drugs

ApprovedMonoclonal antibody (anti-PD-L1)

Durvalumab · Imfinzi

ApprovedMonoclonal antibody (anti-CTLA-4)

Tremelimumab · Imjudo

companies