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Retifanlimab + Chemotherapy for Soft Tissue Sarcoma
Study Summary
This trial is testing a new drug, Retifanlimab, to see if it is safe and effective when combined with two existing chemotherapy drugs, gemcitabine and docetaxel, to treat patients with soft tissue sarcoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 94 Patients • NCT03597295Trial Design
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Who is running the clinical trial?
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- I am currently on medication for an infection.I have not had any systemic therapy before.I have chronic HBV or HCV but it's under control.I haven't had symptoms of autoimmune disease in the last 2 years, except for conditions treated with replacement therapies like insulin.I received initial cancer treatment over a year ago.I am fully active and can carry on all pre-disease activities without restriction.I have completed treatment for hepatitis C and no longer have the virus in my blood.I am not pregnant or breastfeeding.I have had active tuberculosis in the past.I am receiving treatment for hepatitis B.I have not had serious heart problems in the last 6 months.I have a weak immune system due to a condition or medication.I agree to have tumor biopsies for research if my old samples aren't available.I have not had radiation therapy in the last 2 weeks.I am 18 years old or older.I have had an organ or stem-cell transplant.I am not on immunosuppressive medication, except for low-dose steroids or certain topical/inhaled steroids.You have had a serious allergic reaction to the study drug or any of its ingredients in the past.I have not received a live vaccine (other than COVID-19) in the last 30 days.My cancer has grown in an area previously treated with radiation.I have fully recovered from any major surgery before starting treatment.My organs are functioning well.My high-grade soft tissue sarcoma cannot be safely removed by surgery or needs treatment before surgery.I have received treatment for cancer that has spread.I have a history of lung disease and need extra oxygen.
- Group 1: Liposarcoma/LPS
- Group 2: Undifferentiated Pleomorphic Sarcoma/Myxofibrosarcoma
- Group 3: Phase I: Safety Run-In / Dose Level 0
- Group 4: Vascular Sarcoma
- Group 5: Leiomyosarcoma/LMS
- Group 6: Other Soft tissue sarcoma/STS
- Group 7: Phase I: Dose De-escalation Level 1
- Group 8: Phase I: Dose De-escalation Level -1
- Group 9: Phase I: Dose De-escalation Level -2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are being participating in this clinical research?
"That is correct. The clinical trial showed on clinicaltrials.gov is looking for 74 participants at 1 site. The study was first advertised on 9/29/2020 and the most recent update was 10/26/2022."
Can people with the medical condition still enroll in this research project?
"Currently, this clinical trial is looking for participants. The information was first posted on September 29th, 2020 and the last update was October 26th, 2022."
Retifanlimab is primarily given to patients for what purpose?
"Retifanlimab is the standard of care for neoplasm metastasis, and can also help patients with other conditions like bladder cancer, advance directives, and urinary bladder."
What other data exists for Retifanlimab's efficacy?
"There are 783 different ongoing clinical trials for Retifanlimab. 258 of those live clinical trials are in Phase 3 and the majority of studies are based in Shanghai, China. However, there are 43720 locations running trials for this treatment globally."
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