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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Arthralgia

Back pain

Headache

Weight decreased

Urinary tract infection

Proctalgia

Aspartate aminotransferase increased

Abdominal pain

Insomnia

Hypokalaemia

Rash

Cystitis

General physical health deterioration

Pelvic pain

Hypercalcaemia

Inadequate analgesia

Intestinal obstruction

Haematuria

Pleural effusion

Sepsis

Pneumonia

Purpura

Mental status changes

Respiratory failure

Proctitis haemorrhagic

Pseudomonas infection

Acute kidney injury

Anal abscess

Gastroenteritis

Interstitial lung disease

Pancreatic carcinoma

Adrenal insufficiency

Hydronephrosis

Ileus

Flank pain

Immune-mediated enterocolitis

Large intestinal obstruction

Pain

Acute respiratory failure

Cholecystitis acute

Lyme disease

Lymphangiosis carcinomatosa

Herpes zoster

Hepatitis

Pelvic infection

Peritonitis

Blood bilirubin increased

Body temperature increased

Bone pain

Cellulitis

Cholangitis

Cholecystitis

Cognitive disorder

Colonic fistula

Coma hepatic

Dehydration

Device related infection

Diffuse large B-cell lymphoma

Fall

Femur fracture

Gastric ulcer

Skin infection

Stoma site infection

Superior mesenteric artery syndrome

Thrombosis

Transitional cell carcinoma

Tumour embolism

Tumour pain

Ureteric compression

Urinary retention

Venous thrombosis limb

Pulmonary embolism

Catheter site pain

Pneumocystis jirovecii pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Retifanlimab 500 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group VIII: Liposarcoma/LPSExperimental Treatment3 Interventions

Group IX: Leiomyosarcoma/LMSExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Retifanlimab