About this trial
This study is looking at the combination of Retifanlimab with two chemotherapy drugs, gemcitabine and docetaxel. The goal is to see if this combination can safely and effectively treat advanced soft tissue sarcoma that cannot be removed with surgery. Retifanlimab is an experimental drug that helps the immune system to fight cancer cells. Researchers believe it may enhance the effects of the chemotherapy drugs against this type of cancer.
The trial's ID number is NCT04577014. It is in Phase 1 and Phase 2, which means it is looking at how well the treatments work and how safe they are. The trial is FDA-regulated and aims to include about 98 participants.
Who can join
This trial is open to adults aged 18 and older, both men and women, who have advanced soft tissue sarcoma that cannot be surgically removed. Participants must be willing to give consent for a tumor biopsy and must have measurable disease. Patients with certain viral infections like HBV or HCV may be eligible if they meet specific health criteria. The trial team will confirm who can join.
Conditions
Soft Tissue Sarcoma, Sarcoma,Soft Tissue, Sarcoma, Soft Tissue Sarcoma Adult
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will receive different doses of Retifanlimab along with gemcitabine and docetaxel in a planned sequence. Everyone will first take gemcitabine and docetaxel, then Retifanlimab will be added after the first cycle. The study includes several dose levels to find the safest and most effective doses for treatment.
Where
This trial is running at 1 location in the United States. It is currently recruiting.
Memorial Sloan Kettering Cancer Center
New York, New York