Durvalumab and Tremelimumab Compared to Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03317457
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Adult Soft Tissue Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of the trial is to assess the efficacy of Durvalumab and Tremelimumab in comparison to doxorubicin in treatment-naïve Soft tissue sarcoma patients

Key Dates

Start date
Dec 15, 2017
Status verified
Jun 2023
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Tremelimumab
    Cycles/courses 1-3: Durvalumab 1.5g q4wks Tremelimumab 75 mg q4wks Cycles/courses ≥4: Durvalumab 1.5g q4wks Tremelimumab 75 mg q12wks
  • Active Comparator: Doxorubicin
    Doxorubicin 75 mg/qm q3wks for 6 courses

Primary Outcome Measure

overall survival (OS) [ Time Frame: up to 57 months from randomization ]

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