Sintilimab for Locally Advanced Undifferentiated Pleomorphic Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Locally Advanced Undifferentiated Pleomorphic Sarcoma+6 More
Sintilimab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether sintilimab can help treat patients with undifferentiated pleomorphic sarcoma.

See full description

Eligible Conditions

  • Locally Advanced Undifferentiated Pleomorphic Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Unresectable Undifferentiated Pleomorphic Sarcoma
  • Recurrent Undifferentiated Pleomorphic Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Locally Advanced Undifferentiated Pleomorphic Sarcoma

Study Objectives

This trial is evaluating whether Sintilimab will improve 1 primary outcome and 5 secondary outcomes in patients with Locally Advanced Undifferentiated Pleomorphic Sarcoma. Measurement will happen over the course of At 12 weeks.

At 12 weeks
Best overall response rate
Year 3
Duration of response
Year 3
Overall survival
Year 3
Progression free survival
Up to 3 years
Disease control rate
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Locally Advanced Undifferentiated Pleomorphic Sarcoma

Side Effects for

Sintilimab (IBI308)
Lymphocyte count decreased
61%
White blood cell count decreased
50%
Pyrexia
46%
Haemoglobin decreased
32%
Hypothyroidism
32%
Blood thyroid stimulating hormone increased
29%
Blood glucose increased
25%
Upper respiratory tract infection
25%
Blood alkaline phosphatase increased
21%
Blood lactate dehydrogenase increased
21%
Platelet count decreased
21%
Urinary tract infection
18%
Blood bilirubin increased
18%
Blood albumin decreased
18%
Lipase increased
18%
Aspartate aminotransferase increased
18%
Sinusitis
18%
Thyroxine free decreased
18%
Globulins increased
18%
Protein urine present
14%
Rash
14%
Thyroxine increased
14%
Alanine aminotransferase increased
11%
Anaemia
11%
Ventricular extrasystoles
11%
Neutrophil count decreased
11%
Gamma-glutamyltransferase increased
7%
Tri-iodothyronine free decreased
7%
Urine ketone body present
7%
Hypokalaemia
7%
Pneumonia
7%
Respiratory tract infection
7%
Diabetes mellitus
7%
Pharyngitis
7%
C-reactive protein increased
7%
Electrolyte imbalance
7%
Nasal obstruction
7%
Protein total decreased
7%
Globulins decreased
7%
Mouth ulceration
7%
Electrocardiogram abnormal
7%
Gastritis
7%
Enterovirus infection
7%
Constipation
7%
Face oedema
7%
Gingivitis
7%
Red blood cells urine positive
7%
Weight decreased
7%
Lymphadenitis
7%
Pain
7%
Autoimmune thyroiditis
7%
Myocardial ischaemia
7%
Haemoglobin urine present
7%
Thyroid function test abnormal
7%
Headache
7%
Pruritus
7%
Nephrolithiasis
7%
Cough
7%
Myalgia
7%
Oropharyngeal pain
7%
Hypoproteinaemia
7%
Gastrointestinal haemorrhage
4%
Localised infection
4%
Pancreatitis acute
4%
Disease progression
4%
Anaphylactic shock
4%
Diabetic ketoacidosis
4%
Intervertebral disc disorder
4%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03228836) in the Sintilimab (IBI308) ARM group. Side effects include: Lymphocyte count decreased with 61%, White blood cell count decreased with 50%, Pyrexia with 46%, Haemoglobin decreased with 32%, Hypothyroidism with 32%.

Trial Design

1 Treatment Group

Treatment (sintilimab)
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. Sintilimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (sintilimab)
Biological
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Locally Advanced Undifferentiated Pleomorphic Sarcoma or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic UPS
Refractory or intolerant to at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy are eligible
Aged >= 18
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery
Could provide archival or fresh tissues for correlative analysis
Have at least one measurable lesion as per RECIST version (v)1.1
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
Platelet (PLT) count >= 75 x 10^9/L

Patient Q&A Section

What is the survival rate for sarcoma?

"Sarcoma survivors have higher than expected mortality throughout the course of their lives. This is likely due to a combination of factors including late diagnosis, poor quality of life, and dilation of tumor channels resulting in increased pressure in the extremity, and systemic side effects of chemotherapy. Survival rates appear to improve with earlier diagnoses, good quality of life, and early intervention with new adjuvant therapies. Patients who survive more than 5 years of treatment have slightly better outcomes than those who do not complete their full course of treatment in terms of local control and disease free survival. Survival rates were independent of age group and histologic subtype." - Anonymous Online Contributor

Unverified Answer

How serious can sarcoma be?

"Although NCS is the standard of care for patients with sarcoma, there is still significant room for improvement. Further research is needed to determine if more aggressive treatment of sarcoma patients is warranted." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sintilimab?

"A recent analysis of all published clinical trials of sintilimab showed that the most frequent adverse events included fever (59%), headache (44%), fatigue (33%), nausea (27%), rash (23%), dizziness (20%), weight gain (18%), arthralgia/arthritis (17%), vomiting (12%), dyspnoea (11%), leucopenia (8%), thrombocytopenia (5%), anaemia (4%) and cough (4%)." - Anonymous Online Contributor

Unverified Answer

What is sintilimab?

"Sintilimab is a monoclonal antibody against CD25 and is approved by FDA for treating patients with relapsed or refractory cutaneous T-cell lymphoma and B-cell chronic lymphocytic leukaemia in combination with rituximab. The primary indication for sintilimab was marketed by Bristol-Myers Squibb Corporation.\n" - Anonymous Online Contributor

Unverified Answer

Is sintilimab typically used in combination with any other treatments?

"In patients with relapsed or refractory Hodgkin disease, sintilimab is commonly used as monotherapy. However, due to its intrinsic toxicity profile, appropriate use of sintilimab monotherapy should be restricted to specialized centers." - Anonymous Online Contributor

Unverified Answer

Can sarcoma be cured?

"Patients with poor performance status, large lesions, facial involvement, high grade histology or advanced disease present a very poor prognosis in terms of cure. Even patients with minimal residual disease after surgery may still relapse." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing sarcoma?

"The incidence of [soft tissue sarcoma](https://www.withpower.com/clinical-trials/soft-tissue-sarcoma) varies in the population between 0.8% and 1.4%, with a male predominance. A peak incidence occurs in males over 70 years of age. We report a significant increase in incidence since the 1970s, probably as a result of increased exposure to tobacco, pesticides and asbestos. The risk of developing soft tissue sarcoma appears to be greater after radiation therapy. In addition to chemical carcinogens, UV light is also considered to play an important role in causation of sarcoma. This may be due to a dose threshold effect. All benign conditions are excluded from the study, including those related to local trauma or a prior history of malignancy, so no confounding effect is observed." - Anonymous Online Contributor

Unverified Answer

Has sintilimab proven to be more effective than a placebo?

"Sintilimab showed superiority over placebo, especially in patients with advanced melanoma. Findings from a recent study confirms previous results in patients with metastatic melanoma. Further randomized controlled studies are now warranted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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