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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate
Secondary outcome measures
Disease control rate
Duration of response
Overall response rate
+2 moreSide effects data
From 2023 Phase 3 trial • 397 Patients • NCT0360753974%
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
9%
Weight increased
8%
Pneumonia
8%
Amylase increased
8%
Blood creatinine increased
8%
Weight decreased
8%
Oedema peripheral
8%
Hypophagia
8%
Hepatic function abnormal
7%
Abdominal distension
7%
Productive cough
6%
Haemoglobin decreased
6%
Blood thyroid stimulating hormone increased
6%
Chest discomfort
6%
Hiccups
6%
Hyperthyroidism
6%
Blood alkaline phosphatase increased
6%
Hypoproteinaemia
6%
Hyperglycaemia
6%
Headache
5%
Urinary tract infection
5%
Hypertriglyceridaemia
5%
Tachypnoea
5%
Hypercholesterolaemia
5%
Haematuria
5%
Dyspnoea
5%
Hypoaesthesia
5%
Back pain
5%
Hypertension
4%
Haemoptysis
4%
Pain in extremity
2%
Immune-mediated pneumonitis
2%
Pneumonitis
1%
Respiratory failure
1%
Thrombocytopenia
1%
Abdominal pain
1%
Upper gastrointestinal haemorrhage
1%
Pleural effusion
1%
Interstitial lung disease
1%
Atrial fibrillation
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sintilimab Combination
Placebo Combination
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,796 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,661 Total Patients Enrolled
Neeta SomaiahPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count should be at least 75 billion per liter.I have heart failure symptoms or uncontrolled heart rhythm problems.My high blood pressure is not controlled even with treatment.I have been treated with specific immune-targeting drugs.I have a serious infection that is not under control.I haven't had any serious GI issues like perforation or abnormal connections within the last 6 months, except for procedures like gastrostomy.All my side effects from previous cancer treatments, except for hair loss and minor issues, have mostly gone away.I haven't taken any cancer drugs or immune system treatments in the last 2 weeks.My liver function tests are within normal limits.I received treatment to ease symptoms for a local cancer lesion within the last 2 weeks.I cannot tolerate or did not respond to at least one chemotherapy treatment.I have had an organ or stem cell transplant from another person.I have been on IV nutrition for less than 4 weeks due to severe malnutrition.I am fully active or can carry out light work.My liver function tests are within the required limits, even with liver metastasis.I had cancer before, but it's either been treated, is under control, or not expected to need treatment during the trial.You have active hepatitis B or C infections.Your white blood cell count is at least 1.0 x 10^9/L.I haven't had a heart attack, stroke, or similar event in the last 6 months.I don't have an active autoimmune disease needing treatment, except for certain conditions like vitiligo or controlled hypothyroidism.Your hemoglobin level is at least 8.0 grams per deciliter.I haven't had serious blood clots in the last 3 months.I have not received any live vaccines in the last 4 weeks and won't during the study.I have stable brain metastases and haven't needed steroids for 2 weeks.I haven't taken strong immune system suppressing drugs in the last 2 weeks, except for low-dose steroids or local treatments.I have not had major surgery in the last 4 weeks and am not scheduled for any during the trial.I do not have a current bowel blockage or a history of major bowel surgery or chronic inflammatory bowel conditions.I am taking corticosteroids for my lung condition.I cannot undergo surgery or definitive chemoradiotherapy for my condition.I am using effective birth control and will continue for 6 months after the trial ends.My kidney function is good, with low protein in urine and normal creatinine clearance.I have severe liver problems.My cancer is advanced and cannot be removed by surgery.I am 18 years old or older.I do not have any health conditions that could affect the trial's safety or results.You have at least one specific area of the body that can be measured to see if the treatment is working.I can provide tissue samples for testing.I have active tuberculosis in my lungs.My blood clotting ability is within the normal range, even if I'm on blood thinners.I have a known history of primary immunodeficiency.You are expected to live for at least 12 more weeks.I do not have any uncontrolled health conditions that could increase my medical risks.My cancer has spread to my bones, risking paralysis.You have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sintilimab)
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.
Are there any slots available for participants in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this medical investigation is still looking for candidates to participate, with the first posting on July 13th 2021 and most recent modifications occurring October 11th 2022. 25 participants are needed at a single clinical trial site."
Answered by AI
Has this type of clinical trial ever been conducted before?
"As of now, 136 active clinical trials utilizing Sintilimab are taking place in 86 cities and 10 nations. The trial first initiated by Innovent Biologics (Suzhou) Co. Ltd., commenced back in 2017 with 290 participants undergoing Phase 3 drug approval testing. Subsequent to the former's conclusion, 12 other tests have been concluded successfully since then."
Answered by AI
What prior investigations have featured Sintilimab?
"Currently, 136 clinical trials are in progress which focus on Sintilimab. Out of those studies, 15 have advanced to Phase 3 status. At 228 different medical locations throughout Beijing and beyond, research into the application of this drug is taking place."
Answered by AI
How extensive is this research endeavor, and to what extent does it involve human participants?
"Affirmative. According to the clinicaltrials.gov website, this medical experiment is actively seeking participants with recruitment beginning on July 13th 2021 and was last updated October 11th 2022. A total of 25 individuals are required for the trial held at a single location."
Answered by AI
To what extent can Sintilimab be detrimental to patient health?
"Our team has given sintilimab a rating of 2 for safety, as this is currently in a Phase 2 trial with some evidence backing its security but no proof confirming its effectiveness."
Answered by AI
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