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

NCT05017103 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2020-1046NCI-2021-08589
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates the effects of sintilimab in treating patients with undifferentiated pleomorphic sarcoma that has spread to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), come back (recurrent), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate

  Will be defined as the proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) in the evaluable population.

  At 12 weeks

Study Arms (1)

Treatment (sintilimab)

EXPERIMENTAL

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.

Biological: Sintilimab

Interventions

Sintilimab BIOLOGICAL

Given IV

Also known as: Anti-PD-1 Monoclonal Antibody IBI308, Anti-PDCD1 Monoclonal Antibody IBI308, IBI 308, IBI308

Treatment (sintilimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
• Hemoglobin (HGB) \>= 8.0 g/dL
• Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection
• 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
• TBIL =\< 1.5 x ULN and ALT and AST =\< 5 x ULN in subjects with hepatic metastasis. Exception: Patients with known Gilbert disease: serum bilirubin level =\< 3 x ULN

You may not qualify if:

• Received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways
• Enrolled in another interventional clinical study, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study
• Received palliative therapy for local lesion within 2 weeks prior to the first dose
• Received systemic treatment with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment
• Received systemic immunosuppressants within 2 weeks prior to first dose, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media
• Received a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or be scheduled to receive live attenuated vaccine during the study period.
• Note: Seasonal inactivated influenza virus vaccines within 4 weeks prior to the first dose of study treatment are permitted, but attenuated influenza vaccines are not
• Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or is scheduled to receive major surgery during the course of the trial
• Any toxicity (excluding alopecia, events that are not clinically significant, or asymptomatic laboratory abnormalities) due to prior anti-tumor therapy that has not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grade 0 or 1 prior to the first dose of study treatment
• Known symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis. Subjects with brain metastases who have received prior treatment can be enrolled if the disease is stable (no imaging evidence of progressive disease (PD) for at least 4 weeks prior to the first dose of study treatment), there is no evidence of new brain metastases or progression of the existing metastatic lesion(s) upon repeated imaging, and corticosteroids have not been required for at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis are ineligible, regardless of whether the disease is clinically stable or not
• Subjects with bone metastases at risk of paraplegia
• Known active autoimmune disease requiring treatment or previous disease history within 2 years (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or type I diabetes only requiring insulin can be enrolled)
• Known history of primary immunodeficiency diseases
• Known active pulmonary tuberculosis
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Neeta Somaiah, MD
• Organization: M D Anderson Cancer Center

nsomaiah@mdanderson.org

713-792-3626

Study Officials

• Neeta Somaiah, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: July 13, 2021
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: December 11, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-10

Locations

US (1)