Active — Not RecruitingPhase 2

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

United States65 participantsStarted 2020-01-28

Plain-language summary

This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in. The overall objective is to determine the efficacy of combination doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1884 and anti-PD-1 antibody AGEN2034. The investigators will estimate the progression-free survival rate at 6 months (PFS6mo) of doxorubicin plus AGEN1884/AGEN2034 in comparison to historical PFS6mo with doxorubicin monotherapy, calculated as the mean from two large randomized Phase 3 clinical trials.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Provision to sign and date the consent form.
✓. Stated willingness to comply with all study procedures and be available for the duration of the study.
✓. Be male or female aged 18-100 years at the time of signing informed consent.
✓. Have a histological diagnosis of advanced or metastatic soft tissue sarcoma (STS) (by local pathology review), not curable by surgery, for which treatment with doxorubicin is deemed appropriate by the investigator.
✓. Has one of the following histologies:
✓. Have measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
✓. Have received 0 or 1 prior systemic therapies for metastatic sarcoma and NO prior anthracyclines or checkpoint inhibitors.
✓. Adequate organ function as defined in protocol.

Exclusion criteria

What they're measuring

Determine the progression-free survival rate

Timeframe: 6 months

Trial details

NCT IDNCT04028063

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-07

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