Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma (NCT04668300) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
United States75 participantsStarted 2020-11-26
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Age: 18 years of age or older (cohort 1 and cohort 2); 12 years of age or older (cohort 3)
* Histologically or cytologically confirmed sarcoma that fall into one of the following categories. Patients with low-grade tumors are eligible if there is definite evidence of metastasis or progression
* Angiosarcoma
* Dedifferentiated liposarcoma
* Osteosarcoma
* Must have received and have progressed, are refractory or intolerant to standard therapy appropriate for the specific sarcoma subtype, if there is a standard therapy for the subtype
* Subjects must have at least 1 lesion that is measurable by RECIST
* A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed since radiation
* Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator or if no other lesions suitable for biopsy, then a RECIST target lesion used for biopsy must be \>= 2 cm in longest diameter
* Subjected must consent to provide archived tumor specimens for correlative biomarker studies. Tumor tissue must be identified and availability confirmed prior to initiation of study therapy. In the setting where archival material is unavailable or unsuitable for use, or there have been multiple intervening therapies subjects must consent and undergo fresh tumor biopsy. A tumor lesion planned for biopsy must not…