Study on Retifanlimab with Gemcitabine and Docetaxel for Advanced Soft Tissue Sarcoma

Inclusion Criteria

• Have a diagnosis of advanced soft tissue sarcoma that cannot be surgically removed.
• Be willing to provide written consent to participate in the study.
• Agree to provide a tumor sample for research if it is safe to do so.
• Be 18 years or older.
• Have a performance status that allows for daily activities with minimal restrictions.
• Have measurable cancer that can be tracked using standard criteria.
• Have not received prior systemic therapy for advanced or metastatic cancer.
• Women of childbearing potential must have a negative pregnancy test.
• Patients with controlled hepatitis B or C may be eligible.
• Have adequate organ function as determined by specific blood tests.

Exclusion Criteria

• Have received any systemic therapy for advanced or metastatic cancer.
• Have unstable heart disease or recent heart attack or stroke.
• Are currently using medications that suppress the immune system, except for certain low-dose steroids.
• Have significant immune system suppression or autoimmune disease.
• Have uncontrolled HIV infection or active hepatitis B or C.
• Have received a live vaccine within 30 days before starting the study, except for COVID-19 vaccines.
• Have a history of active tuberculosis.
• Have had radiation therapy within two weeks before starting the study.
• Have not fully recovered from major surgery.
• Are pregnant or breastfeeding, or planning to conceive or father a child during the study.
• Have had an organ transplant.
• Have an active infection requiring treatment.
• Have severe allergies to the study drugs or similar medications.
• Have a history of lung disease requiring oxygen support.