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Active Not RecruitingNCT04668300

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

A Phase II Multi-Arm Study to Test the Efficacy of Oleclumab and Durvalumab in Multiple Sarcoma Subtypes

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
75 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the tumor response (Response Evaluation Criteria in Solid Tumors \[RECIST\]) at 4 months in patients with relapsed/refractory sarcoma. (Cohorts 1 and 2) II. To determine the event-free survival (EFS) rate at 4 months after initiation of the treatment in patients with relapsed/refractory osteosarcoma receiving novel immunotherapeutic agents. (Cohort 3) SECONDARY OBJECTIVES: I. To determine the progression-free survival (PFS) rate at 12 weeks after initiation of the treatment in patients with relapsed/refractory sarcoma receiving novel immunotherapeutic agents. II. To estimate the tumor response (Immune-related Response Criteria \[irRC\] and RECIST) in patients with relapsed/refractory sarcoma. III. To evaluate the safety and tolerability of receiving novel immunotherapeutic agents in patients with relapsed/refractory sarcoma. IV. To estimate the median PFS and overall survival (OS) in patients with relapsed/refractory sarcoma receiving novel immunotherapeutic agents. EXPLORATORY OBJECTIVES: I. To determine expression of biomarkers (including but not limited to CD73, PD-1 and PD-L1) in pre \& post treatment (tx) samples. II. Quantification and characterization of the immune infiltrate (and other histologic and immunohistologic changes) from tissue samples prior to treatment initiation and post treatment (biopsy at week 6). III. Identification/quantification of immunologic changes (CD4+, CD8+, Teff, Treg cells and NK cells) in peripheral blood. IV. Determining an immunoscore based on baseline tumor sample (identification of molecular response/resistance patterns/future therapy options). OUTLINE: Patients receive oleclumab intravenously (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. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDurvalumabGiven IV
BIOLOGICALOleclumabGiven IV

Timeline

Start date
2020-11-26
Primary completion
2026-06-30
Completion
2026-06-30
First posted
2020-12-16
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04668300. Inclusion in this directory is not an endorsement.