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Anti-tumor antibiotic
Retifanlimab + Chemotherapy for Soft Tissue Sarcoma
Phase 1 & 2
Recruiting
Led By Evan Rosenbaum, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior systemic therapy (see exclusion criteria, below)
Patients with HCV must have completed curative therapy and have negative HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
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.
Who is the study for?
Adults over 18 with advanced soft tissue sarcoma that can't be surgically removed may join this trial. They should have no prior systemic therapy, controlled hepatitis if present, and good organ function. Pregnant or breastfeeding women, those planning to conceive soon, and individuals with uncontrolled HIV or severe allergies to monoclonal antibodies cannot participate.Check my eligibility
What is being tested?
The trial tests Retifanlimab combined with chemotherapy drugs Gemcitabine and Docetaxel in patients with advanced soft tissue sarcoma. Researchers believe Retifanlimab might enhance the immune system's response when used alongside these chemotherapies.See study design
What are the potential side effects?
Retifanlimab could cause immune-related side effects like inflammation of organs, infusion reactions similar to allergic responses, fatigue, potential blood disorders, and increased risk of infections. Chemotherapy may lead to nausea, hair loss, low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had any systemic therapy before.
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I have completed treatment for hepatitis C and no longer have the virus in my blood.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am receiving treatment for hepatitis B.
Select...
I agree to have tumor biopsies for research if my old samples aren't available.
Select...
I am 18 years old or older.
Select...
My high-grade soft tissue sarcoma cannot be safely removed by surgery or needs treatment before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II: proportion of patients that are progression-free at 24 weeks by RECIST v1.1
Side effects data
From 2021 Phase 2 trial • 94 Patients • NCT0359729523%
Asthenia
21%
Diarrhoea
18%
Fatigue
16%
Nausea
16%
Anaemia
15%
Vomiting
13%
Constipation
13%
Decreased appetite
12%
Pruritus
12%
Cough
12%
Dyspnoea
11%
Pyrexia
10%
Rectal haemorrhage
10%
Hypothyroidism
9%
Arthralgia
9%
Back pain
9%
Headache
9%
Weight decreased
7%
Urinary tract infection
7%
Proctalgia
7%
Aspartate aminotransferase increased
7%
Abdominal pain
6%
Insomnia
5%
Hypokalaemia
5%
Rash
5%
Cystitis
3%
General physical health deterioration
3%
Pelvic pain
2%
Inadequate analgesia
2%
Intestinal obstruction
2%
Hypercalcaemia
2%
Haematuria
2%
Pleural effusion
2%
Sepsis
2%
Pneumonia
1%
Purpura
1%
Acute kidney injury
1%
Flank pain
1%
Immune-mediated enterocolitis
1%
Hydronephrosis
1%
Adrenal insufficiency
1%
Gastroenteritis
1%
Pancreatic carcinoma
1%
Respiratory failure
1%
Pain
1%
Proctitis haemorrhagic
1%
Interstitial lung disease
1%
Large intestinal obstruction
1%
Pseudomonas infection
1%
Anal abscess
1%
Ileus
1%
Mental status changes
1%
Acute respiratory failure
1%
Cholecystitis acute
1%
Lyme disease
1%
Lymphangiosis carcinomatosa
1%
Herpes zoster
1%
Hepatitis
1%
Pelvic infection
1%
Peritonitis
1%
Blood bilirubin increased
1%
Body temperature increased
1%
Bone pain
1%
Cellulitis
1%
Cholangitis
1%
Cholecystitis
1%
Cognitive disorder
1%
Colonic fistula
1%
Coma hepatic
1%
Dehydration
1%
Device related infection
1%
Diffuse large B-cell lymphoma
1%
Fall
1%
Femur fracture
1%
Gastric ulcer
1%
Skin infection
1%
Stoma site infection
1%
Superior mesenteric artery syndrome
1%
Thrombosis
1%
Transitional cell carcinoma
1%
Tumour embolism
1%
Tumour pain
1%
Ureteric compression
1%
Urinary retention
1%
Venous thrombosis limb
1%
Pulmonary embolism
1%
Catheter site pain
1%
Pneumocystis jirovecii pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Retifanlimab 500 mg
Trial Design
9Treatment groups
Experimental Treatment
Group I: Vascular SarcomaExperimental Treatment3 Interventions
After the RP2D is determined, 5 histology-specific cohorts (10 patients each), including UPS/MFS, LPS, LMS, vascular sarcoma, and other STS, will open for enrollment. Patients will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375 mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles), after which treatment with Retifanlimab will continue until unacceptable toxicity, disease progression, or the completion of 35 cycles (105 weeks) of Retifanlimab treatment. All visits are to be done +/-3 days of the scheduled timepoints.
Group II: Undifferentiated Pleomorphic Sarcoma/MyxofibrosarcomaExperimental Treatment3 Interventions
(UPS/MFS)
After the RP2D is determined, 5 histology-specific cohorts (10 patients each), including UPS/MFS, LPS, LMS, vascular sarcoma, and other STS, will open for enrollment. Patients will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375 mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles), after which treatment with Retifanlimab will continue until unacceptable toxicity, disease progression, or the completion of 35 cycles (105 weeks) of Retifanlimab treatment. All visits are to be done +/-3 days of the scheduled timepoints.
Group III: Phase I: Safety Run-In / Dose Level 0Experimental Treatment3 Interventions
A safety run-in (dose level 0 in Table 1, below) will be performed and enroll 6 patients with advanced high-grade sarcoma who are treatment naïve. Cycle one will consist of gemcitabine plus docetaxel at the institution's standard dose and schedule: 900 mg/m2 of gemcitabine on days 1 and 8, and 75 mg/m2 of docetaxel on day 8. Intravenous Retifanlimab at a flat dose of 210 mg will be administered every 3 weeks starting on C2D1 for a total of two cycles (cycles 2 and 3). All visits are to be done +/-3 days of the scheduled timepoints.
Group IV: Phase I: Dose De-escalation Level 1Experimental Treatment3 Interventions
If ≤ 1 patient out of 6 at dose level 0 has a dose-limiting toxicity during this safety run-in, then the dose de-escalation portion of the protocol will commence.
Dose Level 1:
Retifanlimab (Day 1) - 375 mg (flat dose) Gemcitabine (Days 1 and 8) - 900 mg/m2 Docetaxel (Day 8) - 75 mg/m2 All visits are to be done +/-3 days of the scheduled timepoints.
Group V: Phase I: Dose De-escalation Level -2Experimental Treatment3 Interventions
Dose Level -2:
Retifanlimab (Day 1) - 375 mg (flat dose) Gemcitabine (Days 1 and 8) - 675 mg/m2 Docetaxel (Day 8) - 50 mg/m2 All visits are to be done +/-3 days of the scheduled timepoints.
Group VI: Phase I: Dose De-escalation Level -1Experimental Treatment3 Interventions
Dose Level -1:
Retifanlimab (Day 1) - 375 mg (flat dose) Gemcitabine (Days 1 and 8) - 750 mg/m2 Docetaxel (Day 8) - 60 mg/m2 All visits are to be done +/-3 days of the scheduled timepoints.
Group VII: Other Soft tissue sarcoma/STSExperimental Treatment3 Interventions
After the RP2D is determined, 5 histology-specific cohorts (10 patients each), including UPS/MFS, LPS, LMS, vascular sarcoma, and other STS, will open for enrollment. Patients will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375 mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles), after which treatment with Retifanlimab will continue until unacceptable toxicity, disease progression, or the completion of 35 cycles (105 weeks) of Retifanlimab treatment. All visits are to be done +/-3 days of the scheduled timepoints.
Group VIII: Liposarcoma/LPSExperimental Treatment3 Interventions
After the RP2D is determined, 5 histology-specific cohorts (10 patients each), including UPS/MFS, LPS, LMS, vascular sarcoma, and other STS, will open for enrollment. Patients will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375 mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles), after which treatment with Retifanlimab will continue until unacceptable toxicity, disease progression, or the completion of 35 cycles (105 weeks) of Retifanlimab treatment. All visits are to be done +/-3 days of the scheduled timepoints.
Group IX: Leiomyosarcoma/LMSExperimental Treatment3 Interventions
After the RP2D is determined, 5 histology-specific cohorts (10 patients each), including UPS/MFS, LPS, LMS, vascular sarcoma, and other STS, will open for enrollment. Patients will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375 mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles), after which treatment with Retifanlimab will continue until unacceptable toxicity, disease progression, or the completion of 35 cycles (105 weeks) of Retifanlimab treatment. All visits are to be done +/-3 days of the scheduled timepoints.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Retifanlimab
2018
Completed Phase 2
~320
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,852 Total Patients Enrolled
70 Trials studying Sarcoma
13,693 Patients Enrolled for Sarcoma
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,091 Total Patients Enrolled
3 Trials studying Sarcoma
82 Patients Enrolled for Sarcoma
Evan Rosenbaum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
283 Total Patients Enrolled
3 Trials studying Sarcoma
283 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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