TriangleNCT02815995 · OUTCOME
Progression-Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 weeks
What was measured
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.
Groups in this outcome
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.
| Group | Source count |
|---|---|
| Adipocytic Tumors Group | 6 |
| Vascular Tumors Group | 10 |
| Undifferentiated Pleomorphic Sarcoma Group | 5 |
| Synovial Sarcoma Group | 5 |
| Osteosarcoma Group | 5 |
| Other Sarcomas Group | 11 |
| Alveolar Soft-part Sarcoma Group | 10 |
| Chordomas Group | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adipocytic Tumors Group | 0.17 | Not reported | 0.01 | 0.52 | Not reported |
| Vascular Tumors Group | 0.3 | Not reported | 0.07 | 0.58 | Not reported |
| Undifferentiated Pleomorphic Sarcoma Group | 0.4 | Not reported | 0.05 | 0.75 | Not reported |
| Synovial Sarcoma Group | 0.8 | Not reported | 0.2 | 0.97 | Not reported |
| Osteosarcoma Group | 0.2 | Not reported | 0.01 | 0.58 | Not reported |
| Other Sarcomas Group | 0.45 | Not reported | 0.17 | 0.71 | Not reported |
| Alveolar Soft-part Sarcoma Group | 0.9 | Not reported | 0.47 | 0.99 | Not reported |
| Chordomas Group | 0.8 | Not reported | 0.2 | 0.97 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.01
- upper Limit
- 0.52
- value
- 0.17
- group Id
- OG001
- lower Limit
- 0.07
- upper Limit
- 0.58
- value
- 0.3
- group Id
- OG002
- lower Limit
- 0.05
- upper Limit
- 0.75
- value
- 0.4
- group Id
- OG003
- lower Limit
- 0.2
- upper Limit
- 0.97
- value
- 0.8
- group Id
- OG004
- lower Limit
- 0.01
- upper Limit
- 0.58
- value
- 0.2
- group Id
- OG005
- lower Limit
- 0.17
- upper Limit
- 0.71
- value
- 0.45
- group Id
- OG006
- lower Limit
- 0.47
- upper Limit
- 0.99
- value
- 0.9
- group Id
- OG007
- lower Limit
- 0.2
- upper Limit
- 0.97
- value
- 0.8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 5
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Adipocytic Tumors Group
- description
- 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.
- id
- OG001
- title
- Vascular Tumors Group
- description
- 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.
- id
- OG002
- title
- Undifferentiated Pleomorphic Sarcoma Group
- description
- 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.
- id
- OG003
- title
- Synovial Sarcoma Group
- description
- 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.
- id
- OG004
- title
- Osteosarcoma Group
- description
- 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.
- id
- OG005
- title
- Other Sarcomas Group
- description
- 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.
- id
- OG006
- title
- Alveolar Soft-part Sarcoma Group
- description
- 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.
- id
- OG007
- title
- Chordomas Group
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 12 weeks
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- proportion of participants
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Preserved source evidence · Not medical advice