MedDataX Logo

Trial Outcomes & Findings for Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes (NCT NCT02815995)

NCT ID: NCT02815995

Last Updated: 2025-06-12

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20%increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-06-12

Participant Flow

Participant milestones

Participant milestones
Measure
Adipocytic Tumors Group
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Overall Study
STARTED
6
10
5
5
5
11
10
5
Overall Study
COMPLETED
2
1
1
1
2
1
6
4
Overall Study
NOT COMPLETED
4
9
4
4
3
10
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Adipocytic Tumors Group
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Overall Study
Disease Progression
3
7
2
4
3
9
3
1
Overall Study
Adverse Event
1
2
2
0
0
1
0
0
Overall Study
Pregnancy
0
0
0
0
0
0
1
0

Baseline Characteristics

Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Adipocytic Tumors Group
n=6 Participants
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 Participants
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Total
n=57 Participants
Total of all reporting groups
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=24 Participants
5 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
9 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
4 Participants
n=21 Participants
11 Participants
n=10 Participants
8 Participants
n=115 Participants
4 Participants
n=24 Participants
52 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
0 Participants
n=24 Participants
3 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
2 Participants
n=115 Participants
0 Participants
n=24 Participants
4 Participants
n=42 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
9 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=21 Participants
10 Participants
n=10 Participants
4 Participants
n=115 Participants
4 Participants
n=24 Participants
45 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=24 Participants
5 Participants
n=42 Participants
Region of Enrollment
United States
6 participants
n=5 Participants
10 participants
n=7 Participants
5 participants
n=5 Participants
5 participants
n=4 Participants
5 participants
n=21 Participants
11 participants
n=10 Participants
10 participants
n=115 Participants
5 participants
n=24 Participants
57 participants
n=42 Participants
Age, Continuous
64.24 years
STANDARD_DEVIATION 8.39 • n=5 Participants
53.68 years
STANDARD_DEVIATION 13.14 • n=7 Participants
55.18 years
STANDARD_DEVIATION 16.32 • n=5 Participants
35.97 years
STANDARD_DEVIATION 9.13 • n=4 Participants
45.84 years
STANDARD_DEVIATION 17.42 • n=21 Participants
44.49 years
STANDARD_DEVIATION 15.95 • n=10 Participants
34.09 years
STANDARD_DEVIATION 9.88 • n=115 Participants
61.76 years
STANDARD_DEVIATION 6.97 • n=24 Participants
48.18 years
STANDARD_DEVIATION 15.84 • n=42 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
8 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
4 Participants
n=10 Participants
6 Participants
n=115 Participants
1 Participants
n=24 Participants
26 Participants
n=42 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
7 Participants
n=10 Participants
4 Participants
n=115 Participants
4 Participants
n=24 Participants
31 Participants
n=42 Participants

PRIMARY outcome

Timeframe: 12 weeks

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20%increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure
Adipocytic Tumors Group
n=6 Participants
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 Participants
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Progression-Free Survival (PFS)
0.17 proportion of participants
Interval 0.01 to 0.52
0.3 proportion of participants
Interval 0.07 to 0.58
0.4 proportion of participants
Interval 0.05 to 0.75
0.8 proportion of participants
Interval 0.2 to 0.97
0.2 proportion of participants
Interval 0.01 to 0.58
0.45 proportion of participants
Interval 0.17 to 0.71
0.9 proportion of participants
Interval 0.47 to 0.99
0.8 proportion of participants
Interval 0.2 to 0.97

SECONDARY outcome

Timeframe: 8 weeks, confirmatory scan at least 4 wks or later

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure
Adipocytic Tumors Group
n=6 Participants
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 Participants
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Tumor Response
Best Response irRC - N/A
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Tumor Response
Best Response irRC - PD
3 Participants
7 Participants
2 Participants
1 Participants
3 Participants
5 Participants
1 Participants
1 Participants
Tumor Response
Best Response irRC - PR
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
5 Participants
1 Participants
Tumor Response
Best Response irRC - SD
3 Participants
1 Participants
1 Participants
2 Participants
1 Participants
3 Participants
4 Participants
3 Participants
Tumor Response
Best Response irRC - uPD
0 Participants
1 Participants
1 Participants
2 Participants
0 Participants
3 Participants
0 Participants
0 Participants
Tumor Response
Best Response iRecist - N/A
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Tumor Response
Best Response iRecist - PD
3 Participants
7 Participants
2 Participants
0 Participants
3 Participants
5 Participants
1 Participants
1 Participants
Tumor Response
Best Response iRecist - PR
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
4 Participants
1 Participants
Tumor Response
Best Response iRecist - SD
3 Participants
1 Participants
1 Participants
3 Participants
1 Participants
3 Participants
5 Participants
3 Participants
Tumor Response
Best Response iRecist - uPD
0 Participants
1 Participants
1 Participants
2 Participants
0 Participants
3 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 44 months

OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Adipocytic Tumors Group
n=6 Participants
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 Participants
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 Participants
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Overall Survival (OS)
10.99 months
Interval 2.1 to
Not reached. Insufficient number participants with events.
16.41 months
Interval 4.47 to 24.87
4.99 months
Interval 1.51 to 30.85
32.79 months
Interval 7.46 to
Not reached. Insufficient number participants with events.
7.72 months
Interval 1.38 to 21.59
13.31 months
Interval 3.84 to 25.33
NA months
Interval 14.32 to
Not reached. Insufficient number participants with events.
NA months
Not reached. Insufficient number participants with events.

Adverse Events

Adipocytic Tumors Group

Serious events: 5 serious events
Other events: 2 other events
Deaths: 4 deaths

Vascular Tumors Group

Serious events: 7 serious events
Other events: 3 other events
Deaths: 8 deaths

Undifferentiated Pleomorphic Sarcoma Group

Serious events: 4 serious events
Other events: 2 other events
Deaths: 5 deaths

Synovial Sarcoma Group

Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths

Osteosarcoma Group

Serious events: 4 serious events
Other events: 2 other events
Deaths: 5 deaths

Other Sarcomas Group

Serious events: 8 serious events
Other events: 5 other events
Deaths: 10 deaths

Alveolar Soft-part Sarcoma Group

Serious events: 6 serious events
Other events: 4 other events
Deaths: 2 deaths

Chordomas Group

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Adipocytic Tumors Group
n=6 participants at risk
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 participants at risk
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Gastrointestinal disorders
Diarrhea
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
20.0%
2/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Pneumonitis
16.7%
1/6 • 4 years
10.0%
1/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Nervous system disorders
Headache
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Lung infection
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Colitis
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
9.1%
1/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Cardiac disorders
Myocarditis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Blood and lymphatic system disorders
Anemia
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Abdominal pain
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Autoimmune disorder
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Pneumonia
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Nausea
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Vomiting
50.0%
3/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Fever
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Upper respiratory infection
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Chest wall pain
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Nervous system disorders
Seizure
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Nervous system disorders
Stroke
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Flu
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Skin infection
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
Metabolism and nutrition disorders
Dehydration
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
33.3%
2/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Cardiac disorders
Atrial fibrillation
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Ascites
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Disease Progression
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
27.3%
3/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Investigations
Blood bilirubin increased
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Metabolism and nutrition disorders
Hypercalcemia
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Psychiatric disorders
Delirium
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Renal and urinary disorders
Renal and urinary disorders - Other, specify
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Renal and urinary disorders
Acute renal insufficiency
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Surgical and medical procedures
Remove tumor
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Surgical and medical procedures
Surgical and medical procedures - Other, specify
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Gait disturbance
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Enterocolitis infectious
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Flank Pain
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Fatigue
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Infections and infestations - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Wound infection
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
chest
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Myositis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Endocrine disorders
Adrenal insufficiency
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Injury, poisoning and procedural complications
Tracheal obstruction
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Nervous system disorders
Syncope
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps) - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Cardiac disorders
Heart failure
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Pain
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Injury, poisoning and procedural complications
Fracture
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Injury, poisoning and procedural complications
fracture right femur
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years

Other adverse events

Other adverse events
Measure
Adipocytic Tumors Group
n=6 participants at risk
Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Vascular Tumors Group
n=10 participants at risk
Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Undifferentiated Pleomorphic Sarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Synovial Sarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Osteosarcoma Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Other Sarcomas Group
n=11 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Alveolar Soft-part Sarcoma Group
n=10 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Chordomas Group
n=5 participants at risk
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Musculoskeletal and connective tissue disorders
Myositis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Respiratory, thoracic and mediastinal disorders
Pneumonitis
16.7%
1/6 • 4 years
10.0%
1/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Investigations
Lipase increased
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
20.0%
1/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Investigations
Serum amylase increased
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Investigations
Alkaline phosphatase increased
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Infections and infestations
Lung infection
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Immune system disorders
Autoimmune disorder
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Thrush
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Diarrhea
16.7%
1/6 • 4 years
20.0%
2/10 • 4 years
20.0%
1/5 • 4 years
20.0%
1/5 • 4 years
20.0%
1/5 • 4 years
27.3%
3/11 • 4 years
30.0%
3/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
33.3%
2/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Colitis
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
20.0%
2/10 • 4 years
0.00%
0/5 • 4 years
Endocrine disorders
Thyroiditis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Endocrine disorders
Endocrine disorders - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Cardiac disorders
Myocarditis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Pruritus
33.3%
2/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
20.0%
2/10 • 4 years
40.0%
2/5 • 4 years
Skin and subcutaneous tissue disorders
Rash maculo-papular
16.7%
1/6 • 4 years
20.0%
2/10 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
40.0%
4/10 • 4 years
40.0%
2/5 • 4 years
Skin and subcutaneous tissue disorders
Rash (left shoulder)
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Rash (Left Leg)
16.7%
1/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Fatigue
16.7%
1/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
18.2%
2/11 • 4 years
30.0%
3/10 • 4 years
40.0%
2/5 • 4 years
Gastrointestinal disorders
Nausea
16.7%
1/6 • 4 years
20.0%
2/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/11 • 4 years
20.0%
2/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Vomiting
16.7%
1/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Fever
16.7%
1/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
20.0%
2/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Flu like symptoms
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Rash lower back
0.00%
0/6 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
20.0%
1/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
General disorders
Malaise
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Dry mouth
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
20.0%
1/5 • 4 years
Gastrointestinal disorders
Abdominal pain
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Flatulence
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Proctitis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/11 • 4 years
10.0%
1/10 • 4 years
0.00%
0/5 • 4 years
General disorders
General disorders and administration site conditions - Other, specify
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
Gastrointestinal disorders
Bloating
0.00%
0/6 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
0.00%
0/5 • 4 years
9.1%
1/11 • 4 years
0.00%
0/10 • 4 years
0.00%
0/5 • 4 years

Additional Information

Dr. Neeta Somaiah

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-3626

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place