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Monoclonal Antibodies

Sintilimab for Sarcoma

Phase 2

Waitlist Available

Led By Neeta Somaiah

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total bilirubin (TBIL) =< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) in subjects without hepatic metastasis

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Must not have

Symptomatic congestive heart failure (New York Heart Association [NYHA] class II-IV) or symptomatic or poorly controlled arrhythmia

Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) despite of standard treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing sintilimab to treat patients with undifferentiated pleomorphic sarcoma. Sintilimab is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?

Adults with a specific cancer called undifferentiated pleomorphic sarcoma that's advanced, spread to other parts of the body, returned after treatment, or can't be surgically removed. They must have tried at least one chemotherapy and not be suitable for certain treatments. Participants need functioning kidneys, no major surgery within 4 weeks before the trial starts, and they should agree to use contraception during the study.

What is being tested?

The trial is testing Sintilimab, an immunotherapy drug designed to help the immune system fight cancer by blocking tumor growth and spread. It's given to patients whose cancer has progressed despite previous treatments. The study aims to see how well this drug works on its own in these cases.

What are the potential side effects?

Sintilimab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) and skin reactions. Other possible side effects include fatigue, infusion reactions like fever or chills, muscle pain and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within normal limits.

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I am fully active or can carry out light work.

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I cannot undergo surgery or definitive chemoradiotherapy for my condition.

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My kidney function is good, with low protein in urine and normal creatinine clearance.

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My cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart failure symptoms or uncontrolled heart rhythm problems.

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My high blood pressure is not controlled even with treatment.

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I have been treated with specific immune-targeting drugs.

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I have a serious infection that is not under control.

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I haven't had any serious GI issues like perforation or abnormal connections within the last 6 months, except for procedures like gastrostomy.

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I have had an organ or stem cell transplant from another person.

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I haven't had a heart attack, stroke, or similar event in the last 6 months.

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I have not had major surgery in the last 4 weeks and am not scheduled for any during the trial.

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I do not have a current bowel blockage or a history of major bowel surgery or chronic inflammatory bowel conditions.

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I am taking corticosteroids for my lung condition.

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I have severe liver problems.

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I have active tuberculosis in my lungs.

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I have a known history of primary immunodeficiency.

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My cancer has spread to my bones, risking paralysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Response Rate

Secondary study objectives

Disease control rate

Duration of response

Overall response rate

+2 more

Side effects data

From 2023 Phase 3 trial • 397 Patients • NCT03607539

74%

Anaemia

71%

Neutrophil count decreased

68%

White blood cell count decreased

42%

Platelet count decreased

41%

Aspartate aminotransferase increased

41%

Nausea

41%

Alanine aminotransferase increased

38%

Decreased appetite

33%

Asthenia

29%

Vomiting

27%

Constipation

21%

Pyrexia

20%

Hypoalbuminaemia

14%

Rash

13%

Lymphocyte count decreased

13%

Diarrhoea

12%

Cough

12%

Gamma-glutamyltransferase increased

11%

Insomnia

11%

Hypothyroidism

11%

Hypokalaemia

11%

Hyponatraemia

11%

Proteinuria

11%

Dizziness

10%

Upper respiratory tract infection

10%

Blood glucose increased

Weight increased

Pneumonia

Amylase increased

Blood creatinine increased

Weight decreased

Oedema peripheral

Hypophagia

Hepatic function abnormal

Abdominal distension

Productive cough

Haemoglobin decreased

Blood thyroid stimulating hormone increased

Chest discomfort

Hiccups

Hyperthyroidism

Blood alkaline phosphatase increased

Hypoproteinaemia

Hyperglycaemia

Headache

Urinary tract infection

Hypertriglyceridaemia

Tachypnoea

Hypercholesterolaemia

Haematuria

Dyspnoea

Hypoaesthesia

Back pain

Hypertension

Haemoptysis

Pain in extremity

Immune-mediated pneumonitis

Pneumonitis

Respiratory failure

Thrombocytopenia

Abdominal pain

Upper gastrointestinal haemorrhage

Pleural effusion

Interstitial lung disease

Atrial fibrillation

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Sintilimab Combination

Placebo Combination

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (sintilimab)Experimental Treatment1 Intervention

Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sintilimab

Not yet FDA approved

0 / 19Eligibility criteria met