Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04668300
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Angiosarcoma
  • Metastatic Dedifferentiated Liposarcoma
  • Metastatic Osteosarcoma
  • Recurrent Angiosarcoma
  • Recurrent Dedifferentiated Liposarcoma
  • Recurrent Osteosarcoma
  • Refractory Dedifferentiated Liposarcoma
  • Refractory Osteosarcoma

Eligibility Criteria

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

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Oleclumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial investigates how well oleclumab and durvalumab work in treating patients with sarcoma that has come back (recurrent) or does not respond to treatment (refractory) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as oleclumab and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Nov 26, 2020
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oleclumab, durvalumab)
    Patients receive oleclumab IV over 1 hour every 2 weeks for 5 doses, then every 4 weeks thereafter. Patients also receive durvalumab IV over 1 hour every 4 weeks. Cycle repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response rate (Cohorts 1 and 2) [ Time Frame: At 4 months post treatment initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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