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Anti-tumor antibiotic

Retifanlimab + Chemotherapy for Soft Tissue Sarcoma

Phase 1 & 2
Waitlist Available
Led By Sandra P D'Angelo, 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
Must not have
Active infection requiring systemic therapy
Women who are pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

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.
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.
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 below
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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.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am receiving treatment for hepatitis B.
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I agree to have tumor biopsies for research if my old samples aren't available.
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I am 18 years old or older.
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My high-grade soft tissue sarcoma cannot be safely removed by surgery or needs treatment before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication for an infection.
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I am not pregnant or breastfeeding.
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I have had active tuberculosis in the past.
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I have not had serious heart problems in the last 6 months.
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I have a weak immune system due to a condition or medication.
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I have not had radiation therapy in the last 2 weeks.
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I have had an organ or stem-cell transplant.
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I have received treatment for cancer that has spread.
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I have a history of lung disease and need extra oxygen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 • NCT03597295
23%
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%
Hypothyroidism
10%
Rectal haemorrhage
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%
Hypercalcaemia
2%
Inadequate analgesia
2%
Intestinal obstruction
2%
Haematuria
2%
Pleural effusion
2%
Sepsis
2%
Pneumonia
1%
Acute kidney injury
1%
Anal abscess
1%
Gastroenteritis
1%
Interstitial lung disease
1%
Pancreatic carcinoma
1%
Pseudomonas infection
1%
Purpura
1%
Respiratory failure
1%
Adrenal insufficiency
1%
Hydronephrosis
1%
Mental status changes
1%
Proctitis haemorrhagic
1%
Ileus
1%
Flank pain
1%
Immune-mediated enterocolitis
1%
Large intestinal obstruction
1%
Pain
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
~1920

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,489 Total Patients Enrolled
70 Trials studying Sarcoma
13,644 Patients Enrolled for Sarcoma
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
56,985 Total Patients Enrolled
3 Trials studying Sarcoma
82 Patients Enrolled for Sarcoma
Sandra P D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Docetaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04577014 — Phase 1 & 2
Sarcoma Research Study Groups: Liposarcoma/LPS, Undifferentiated Pleomorphic Sarcoma/Myxofibrosarcoma, Phase I: Safety Run-In / Dose Level 0, Vascular Sarcoma, Leiomyosarcoma/LMS, Other Soft tissue sarcoma/STS, Phase I: Dose De-escalation Level 1, Phase I: Dose De-escalation Level -1, Phase I: Dose De-escalation Level -2
Sarcoma Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04577014 — Phase 1 & 2
Docetaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577014 — Phase 1 & 2
~13 spots leftby Sep 2025
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