Durvalumab and Tremelimumab for Pediatric Malignancies | NCT03837899

ID	Type	Description	Link
2023-510424-68-00	Registry Identifier	CTIS (EU)
2018-003118-42	EudraCT Number

Label	Type	Description	Intervention Names
Durvalumab / Tremelimumab Combination Therapy	Experimental	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)	Drug: Durvalumab / Tremelimumab Combination Therapy

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab / Tremelimumab Combination Therapy	Drug	Starting dose: durvalumab: 20mg/kg tremelimumab: 1mg/kg at cycles 2 to 5 only co-administered with durvalumab. The Recommended Phase 2 dose will be used for the dose expansion phase.

Measure	Description	Time Frame
Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab	Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.	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	Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.	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: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab	Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.	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	Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.	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	Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.	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

Measure	Description	Time Frame
Dose-Expansion Phase: Cmax of Durvalumab	Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.	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, 8, and 12

Name	Affiliation	Role
Ashok Gupta, MD, PhD	AstraZeneca Global Medicines Development, Academy House	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Baltimore	Maryland	21231	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
42222420	Derived	Hargrave D, Marshall LV, Andre N, Krystal J, Ladle BH, Robbins KA, Hois S, Armstrong J, Donegan S. Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors. Front Oncol. 2026 May 15;16:1680081. doi: 10.3389/fonc.2026.1680081. eCollection 2026.

Label	URL
Study Protocol	View source

ID	Title	Description
FG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kilograms (kg) were administered durvalumab 20 milligram (mg)/kg intravenously (IV) in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 12, 2022	Nov 16, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

The pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study treatment per the clinical study protocol (CSP) for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/ milliliter (mcg/mL)

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG002	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG003	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Units	Counts
Participants	OG0007 OG00111 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG000363± 58.0 OG001865± 36.0 OG002275± 135 OG003

Primary

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

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis. Only data from the participants analyzed were reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Posted

Median

Full Range

days

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

days

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab

Serum samples were collected from the participants at the defined timepoints. AUC(0-14)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab

Serum samples were collected from the participants at the defined timepoints. AUC(0-28)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Cmax of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Cmin of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

Pre-infusion and post-infusion on Cycle 2 Day 1, and Cycle 2 Day 8

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: (AUC 0-28) of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Tmax of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Posted

Median

Full Range

days

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: T½λz of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

days

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: AUC (0-14)/D of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. AUC(0-14)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

Pre-infusion and post-infusion on Cycle 2 Day 1 and Cycle 2 Day 8

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: AUC (0-28)/D of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. AUC(0-28)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Cmax/D of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(mcg/mL)/(mg/kg)

Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Some AEs and higher-level terms were considered AESI or AEPIs and this list of categories were provided by the patient safety team.

The Safety analysis set included all participants who received any amount of study treatment.

Posted

Count of Participants

Participants

From Day 1 up to 15 months

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Primary

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

ORR as per RECIST 1.1 was defined as the percentage of participants with at least 1 investigator-assessed visit response of complete response (CR) or partial response (PR) that was subsequently confirmed on another scan not less than 4 weeks after visit observed response. CR was defined as disappearance of all target lesions (TLs), any pathological lymph nodes selected as TLs with reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met.

The evaluable for response analysis set is the subset of participants in the FAS who had measurable disease (as per RECIST 1.1) at baseline and had at least 1 follow-up scan measuring all required target lesions and had been followed for at least 3 cycles or measurable disease (as per RECIST 1.1) at baseline and progressed or died in the absence of a follow-up scan.

Posted

Number

percentage of participants

From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

Duration of response was the time from the first documentation of CR/PR (which was subsequently confirmed) until the date of documented progression, or death which coincides with the progression free survival (PFS) endpoint. For participants who did not progress following a response, the DOR was censored during the PFS censoring time. It was calculated using Kaplan-Meier technique.

Posted

Median

Full Range

months

From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001

Primary

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

BOR was calculated based on the overall visit responses from each RECIST 1.1 assessment. Categorization of BOR for solid tumors were based on RECIST 1.1 using the following response categories: CR, PR, stable disease (SD), progression of disease (PD), and not evaluable (NE). CR: disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to <10 mm. PR: 30% decrease in the sum of diameters of TLs. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD. PD: >= 20 % increase in the sum of diameters to TLs and an increase of >= 5 mm. NE: Only relevant if any of the TLs were not assessed or NE or had a lesion intervention at visit. Non-CR/Non-PD: Persistence of 1+ non-target lesion (s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline.

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Primary

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

DCR was defined as the percentage of participants who achieved a BOR of unconfirmed CR or PR, respectively, or who had SD. CR was defined as disappearance of all TLs, any pathological lymph nodes selected as TLs with reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD.

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment. Only participants who achieved a BOR were included in the analysis.

Posted

Number

percentage of participants

At 16 and 24 Weeks

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Primary

Dose-Expansion Phase Only: PFS

PFS as per RECIST 1.1 was defined as the time from the date of first dose of study treatment until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the participant withdrew from study therapy or received another anti-cancer therapy prior to progression (date of PFS event or censoring - date of first dose + 1). Confidence interval was calculated using Kaplan-Meier technique.

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

Posted

Median

90% Confidence Interval

months

From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Primary

Dose-Expansion Phase Only: Overall Survival (OS)

OS was defined as the time from the date of first dose of study treatment until death due to any cause regardless of whether the patient withdraws from study treatment or received another anti-cancer therapy (i.e date of death or censoring - date of first dose + 1).

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

Posted

Median

Inter-Quartile Range

months

From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Primary

Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months

Survival rates were defined as the Kaplan-Meier estimate of OS at 12 and 24 months.

The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

Posted

Number

90% Confidence Interval

percentage of participants

At 12 and 24 Weeks

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmax of Durvalumab

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

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, 8, and 12

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmin of Durvalumab

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

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, 8, and 12

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: AUC (0-28) of Durvalumab

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Tmax of Durvalumab

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Posted

Median

Full Range

days

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, 8, and 12

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: T½λz of Durvalumab

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

days

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, 8, and 12

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: AUC (0-28)/D of Durvalumab

Serum samples were collected from the participants at the defined timepoints. AUC (0-28)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmax/D of Durvalumab

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(mcg/mL)/(mg/kg)

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, 8, and 12

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmax of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmin of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: AUC (0-28) of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

day*mcg/mL

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Tmax of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Posted

Median

Full Range

days

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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: T½λz of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

days

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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

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

Serum samples were collected from the participants at the defined timepoints. AUC (0-14)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: AUC (0-28)/D of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. AUC (0-28)/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(day*mcg/mL)/(mg/kg)

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

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Expansion Phase: Cmax/D of Tremelimumab

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

(mcg/mL)/(mg/kg)

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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.

Secondary

Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs)

ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.

The ADA analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom baseline, and any post-dose data were available were included in the ADA analysis set. Only data from the participants analyzed were reported.

Posted

Number

percentage of participants

Pre-infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab), pre-infusion on Cycle 2 Day 1, Cycle 5 Day 1 and Cycle 8 Day 1 for tremelimumab

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001

Secondary

Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs

ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. The category includes participants meeting these criteria who are ADA positive at baseline. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category includes participants meeting these criteria who are ADA positive at baseline.

Posted

Number

percentage of participants

Pre-infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab) and random sample on Cycle 7 Day 1 for tremelimumab

ID	Title	Description
OG000	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Secondary

Number of Participants With Individual Antibody Titer Measurement

Blood samples were planned to be collected for vaccine antibody titer measurements before and after planned routine immunization.

Participants who has a baseline titer collected and who has subsequent samples following a routine childhood immunization were included. As no participants received a routine immunization during the study, no additional samples were collected, hence no data analysed.

Posted

Count of Participants

Participants

Pre-infusion on Cycle 1 Day 1 and Cycle 4 Day 1 for durvalumab, pre-infusion on Cycle 1 Day 1, pre-infusion on Cycle 3, 4, and 8 Day 1 for tremelimumab (dose-expansion)

ID	Title	Description
OG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
OG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Secondary

Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67

Blood samples were collected at indicated timepoints for flow cytometry assessment. Cycle (C) and Day (D). Data collected for the flow cytometry analysis from the participants enrolled in both the dose finding and dose expansion phase were analyzed in the context of the dosing regimen received, to determine any potential differences in the immune response based on the durvalumab dose.

Participants who received the Durvalumab + tremelimumab combination who had a pre-treatment sample collected on Day 1 and a repeat sample on Day 8 were included. As the weight of the participant was not believed to impact the immune response, it was determined that aggregating the data by dosing regimen rather than by weight group, was considered acceptable for this particular analysis.

Posted

Median

Inter-Quartile Range

percentage of cells per cubic millimeter

Pre-dose Cycle 1 Day 8, pre-dose Cycle 2 Day 1, Cycle 2 Day 8, pre-dose Cycle 3 Day 1 (Dose-finding); Pre-dose Cycle 1 Day 1, Cycle 1 Day 8, pre-dose Cycle 2 Day 1 (Dose-expansion)

ID	Title	Description
OG000	Dose Expansion: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants from cohort SARCOMA and STO, who were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5, onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypothyroidism	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected11 at risk EG0020 events0 affected3 at risk EG0031 events1 affected8 at risk EG0041 events1 affected11 at risk EG0051 events1 affected10 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Amputation stump pain	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Anosmia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0015 events4 affected11 at risk EG0020 events0 affected3 at risk EG003
Horner's syndrome	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Presyncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Retinal migraine	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Somnolence	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected11 at risk EG0020 events0 affected3 at risk EG003
Irritability	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events3 affected11 at risk EG0020 events0 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Skin depigmentation	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Hot flush	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events3 affected11 at risk EG0021 events1 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0013 events2 affected11 at risk EG0021 events1 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG00110 events7 affected11 at risk EG0020 events0 affected3 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events3 affected7 at risk EG0013 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Chest pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Haemolysis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Complication associated with device	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Papillitis	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Bed bug infestation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Folliculitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Oral infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Paronychia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Periorbital infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Rhinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0022 events2 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0016 events1 affected11 at risk EG0021 events1 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events4 affected11 at risk EG0021 events1 affected3 at risk EG003
Amylase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events2 affected11 at risk EG0021 events1 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events3 affected11 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Blood urea increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Blood uric acid increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
C-reactive protein increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events1 affected11 at risk EG0021 events1 affected3 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Lipase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0021 events1 affected3 at risk EG003
Weight increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
White blood cell count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0004 events2 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0021 events1 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0021 events1 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected11 at risk EG0020 events0 affected3 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Embryonal rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003

ID	Term
D009371	Neoplasms by Site
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description
BG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
BG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
BG002	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
BG003	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
BG004	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
BG005	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	6	7	1	7	6	7
EG001	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed >= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	8	11	1	11	11	11
EG002	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	3	3	0	3	3	3
EG003	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants who weighed < 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	7	8	1	8	7	8
EG004	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	8	11	6	11	8	11
EG005	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg	Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.	7	10	3	10	9	10

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Transverse sinus thrombosis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG0031 events1 affected8 at risk EG0040 events0 affected11 at risk EG0050 events0 affected10 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected11 at risk EG0020 events0 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected11 at risk EG0020 events0 affected3 at risk EG003