Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study

Phase 2

Terminated

• Conditions: Locally Advanced Undifferentiated Pleomorphic Sarcoma; Metastatic Undifferentiated Pleomorphic Sarcoma; Recurrent Undifferentiated Pleomorphic Sarcoma; Unresectable Undifferentiated Pleomorphic Sarcoma

• Registration Number: NCT05017103
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-8-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Histopathologically confirmed unresectable, locally advanced, recurrent or<br> metastatic UPS<br><br> - Refractory or intolerant to at least one line of systemic chemotherapy. Patient<br> ineligible for cytotoxic chemotherapy are eligible<br><br> - Aged >= 18<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1<br><br> - Subject must be unsuitable for definitive treatment, such as definitive<br> chemoradiotherapy and/or surgery<br><br> - Could provide archival or fresh tissues for correlative analysis<br><br> - Have at least one measurable lesion as per RECIST version (v)1.1<br><br> - Absolute neutrophil count (ANC) >= 1.0 x 10^9/L<br><br> - Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or<br> granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood<br> collection<br><br> - Platelet (PLT) count >= 75 x 10^9/L<br><br> - Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or<br> granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood<br> collection<br><br> - Hemoglobin (HGB) >= 8.0 g/dL<br><br> - Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or<br> granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood<br> collection<br><br> - Total bilirubin (TBIL) =< 1.5 x upper limit of normal (ULN) and alanine<br> aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of<br> normal (ULN) in subjects without hepatic metastasis<br><br> - TBIL =< 1.5 x ULN and ALT and AST =< 5 x ULN in subjects with hepatic metastasis.<br> Exception: Patients with known Gilbert disease: serum bilirubin level =< 3 x ULN<br><br> - Urine protein < 2+ from random sample or < 1 g from 24-hour urine collection, and<br> creatinine clearance rate (Ccr) >= 60 mL/min by Cockcroft-Gault formula<br><br> - Adequate coagulation function, defined as international normalized ratio (INR) =<<br> 1.5 or prothrombin time (PT) =< 1.5 x ULN; if the subject is receiving anticoagulant<br> therapy, the results of coagulation tests need to be within the acceptable range for<br> anticoagulants<br><br> - Expected survival >= 12 weeks<br><br> - Subject (female subjects of childbearing age or male subjects whose partners are of<br> childbearing age) must take effective contraceptive measures during the entire<br> course of the trial and until 180 days after the last dose<br><br> - Signed the informed consent form (ICF) and be able to comply with the scheduled<br> follow-up visits and related procedures required in the protocol<br><br>Exclusion Criteria:<br><br> - Received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or<br> anti-CTLA-4 antibody, or any other antibody or drug that specifically targets T-cell<br> co-stimulation or immune checkpoint pathways<br><br> - Enrolled in another interventional clinical study, unless only involved in an<br> observational study (non-interventional) or in the follow-up phase of an<br> interventional study<br><br> - Received palliative therapy for local lesion within 2 weeks prior to the first dose<br><br> - Received systemic treatment with anti-cancer indications or immunomodulators<br> (including thymosins, interferons, and interleukins) within 2 weeks prior to the<br> first dose of study treatment<br><br> - Received systemic immunosuppressants within 2 weeks prior to first dose, excluding<br> local use of glucocorticoids administered by nasal, inhaled, or other routes, and<br> systemic glucocorticoids at physiological doses (no more than 10 mg/day of<br> prednisone or equivalents), or glucocorticoids to prevent allergies to contrast<br> media<br><br> - Received a live attenuated vaccine within 4 weeks prior to the first dose of study<br> treatment or be scheduled to receive live attenuated vaccine during the study<br> period.<br><br> - Note: Seasonal inactivated influenza virus vaccines within 4 weeks prior to the<br> first dose of study treatment are permitted, but attenuated influenza vaccines<br> are not<br><br> - Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior<br> to the first dose of study treatment or is scheduled to receive major surgery during<br> the course of the trial<br><br> - Any toxicity (excluding alopecia, events that are not clinically significant, or<br> asymptomatic laboratory abnormalities) due to prior anti-tumor therapy that has not<br> yet resolved to National Cancer Institute Common Terminology Criteria for Adverse<br> Events (NCI CTCAE) v5.0 grade 0 or 1 prior to the first dose of study treatment<br><br> - Known symptomatic central nervous system (CNS) metastasis or carcinomatous<br> meningitis. Subjects with brain metastases who have received prior treatment can be<br> enrolled if the disease is stable (no imaging evidence of progressive disease (PD)<br> for at least 4 weeks prior to the first dose of study treatment), there is no<br> evidence of new brain metastases or progression of the existing metastatic lesion(s)<br> upon repeated imaging, and corticosteroids have not been required for at least 14<br> days prior to the first dose of study treatment. Patients with carcinomatous<br> meningitis are ineligible, regardless of whether the disease is clinically stable or<br> not<br><br> - Subjects with bone metastases at risk of paraplegia<br><br> - Known active autoimmune disease requiring treatment or previous disease history<br> within 2 years (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not<br> requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or<br> type I diabetes only requiring insulin can be enrolled)<br><br> - Known history of primary immunodeficiency diseases<br><br> - Known active pulmonary tuberculosis<br><br> - Known history of allogeneic organ transplantation or allogeneic hematopoietic stem<br> cell transplantation<br><br> - Human immunodeficiency virus (HIV)-infected subjects (positive anti-HIV antibody)<br><br> - Active or poorly controlled serious infections<br><br> - Symptomatic congestive heart failure (New York Heart Association [NYHA] class II-IV)<br> or symptomatic or poorly controlled arrhythmia<br><br> - Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood<br> pressure >= 100 mmHg) despite of standard treatment<br><br> - Any arterial thromboembolic event within 6 months prior to enrollment, including<br> myocardial infarction, unstable angina, cerebrovascular accident, or transient<br> cerebral ischemic attack<br><br> - Significant malnutrition, such as those requiring continuous parenteral nutrition >=<br> 7 days; excluding those having received intravenous treatment for malnutrition for<br> more than 4 weeks before the first dose of study treatment<br><br> - History of clinically significant deep venous thrombosis, pulmonary embolism, or<br> other serious thromboembolic events within 3 months prior to enrollment (implantable<br> port or catheter-related thrombosis or incidental PE detected on scan without<br> symptoms or superficial venous thrombosis are not considered as serious<br> thromboembolisms)<br><br> - Uncontrolled metabolic disorders, non-malignant organ or systemic diseases, or<br> cancer-related secondary diseases that may lead to higher medical risks and/or<br> survival evaluation uncertainties<br><br> - Hepatic encephalo

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best overall response rate

Secondary Outcome Measures

Name	Time	Method
Overall response rate;Disease control rate;Duration of response;Progression free survival;Overall survival