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NCT02815995 · OUTCOME

Overall Survival (OS)

Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes · Source last updated 2025-06-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
44 months

What was measured

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

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Adipocytic Tumors Group6
Vascular Tumors Group10
Undifferentiated Pleomorphic Sarcoma Group5
Synovial Sarcoma Group5
Osteosarcoma Group5
Other Sarcomas Group11
Alveolar Soft-part Sarcoma Group10
Chordomas Group5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adipocytic Tumors Group10.99Not reported2.1NANot reached. Insufficient number participants with events.
Vascular Tumors Group16.41Not reported4.4724.87Not reported
Undifferentiated Pleomorphic Sarcoma Group4.99Not reported1.5130.85Not reported
Synovial Sarcoma Group32.79Not reported7.46NANot reached. Insufficient number participants with events.
Osteosarcoma Group7.72Not reported1.3821.59Not reported
Other Sarcomas Group13.31Not reported3.8425.33Not reported
Alveolar Soft-part Sarcoma GroupNANot reported14.32NANot reached. Insufficient number participants with events.
Chordomas GroupNANot reportedNANANot reached. Insufficient number participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached. Insufficient number participants with events.
        group Id
        OG000
        lower Limit
        2.1
        upper Limit
        NA
        value
        10.99
      2. group Id
        OG001
        lower Limit
        4.47
        upper Limit
        24.87
        value
        16.41
      3. group Id
        OG002
        lower Limit
        1.51
        upper Limit
        30.85
        value
        4.99
      4. comment
        Not reached. Insufficient number participants with events.
        group Id
        OG003
        lower Limit
        7.46
        upper Limit
        NA
        value
        32.79
      5. group Id
        OG004
        lower Limit
        1.38
        upper Limit
        21.59
        value
        7.72
      6. group Id
        OG005
        lower Limit
        3.84
        upper Limit
        25.33
        value
        13.31
      7. comment
        Not reached. Insufficient number participants with events.
        group Id
        OG006
        lower Limit
        14.32
        upper Limit
        NA
        value
        NA
      8. comment
        Not reached. Insufficient number participants with events.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      5
    units
    Participants
description
OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
MEDIAN
reporting Status
POSTED
time Frame
44 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice