Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study

NCT05026736 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-1212NCI-2021-08962
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or has come back (recurrent). 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. Giving sintilimab may help to control angiosarcoma.

Conditions

Locally Advanced Angiosarcoma; Metastatic Angiosarcoma; Recurrent Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free rate

  Defined as the proportion of subjects with no confirmed progressive disease (PD) at 9 cycles assessed by the independent radiology review based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) in the evaluable population.

  At 9 cycles (1 cycle = 21 days)

Secondary Outcomes (6)

• Duration of response

  From first date of investigator-determined response to investigator-determined progressive disease (PD) or death in the subjects who have achieved complete response (CR) or partial response (PR), assessed up to 5 years

• Progression free survival

  From treatment onset to either disease progression as defined by RECIST or death from any cause, or discontinuation of treatment for any reason, whichever occurs first, assessed up to 5 years

• Overall survival

  From treatment onset to death, assessed up to 5 years

• Objective response rate (complete response + partial response)

  Up to 5 years

• Stable disease rate

  Up to 5 years

Study Arms (1)

Treatment (sintilimab)

EXPERIMENTAL

Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue to receive treatment at the discretion of the treating physician.

Other: Quality-of-Life Assessment; Biological: Sintilimab

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (sintilimab)

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 angiosarcoma
• Intolerant to or progressed on at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy are eligible
• Aged \>= 18
• Can provide archival or fresh tissues for optional correlative analysis
• Have at least one measurable lesion as per RECIST version (v)1.1
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
• Platelet (PLT) count \>= 75 x 10\^9/L
• Hemoglobin (HGB) \>= 8.0 g/dL
• Total bilirubin (TBIL) =\< 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN in subjects without hepatic metastasis; ALT and AST =\< 5 x ULN in subjects with hepatic metastasis, gamma-glutamyl transferase (GGT) =\< 10 x ULN
• Urine protein \< 2+ from random sample or \< 1 g from 24-hour urine collection
• Serum creatinine =\< 1.5 x ULN or calculated creatinine clearance rate (Ccr) \>= 50 mL/min by Cockcroft-Gault formula
• Adequate coagulation function, defined as international normalized ratio (INR) =\< 1.5 or prothrombin time (PT) =\< 1.5 x ULN; if the subject is receiving anticoagulant therapy, the results of coagulation tests need to be within the acceptable range for anticoagulants
• Expected survival \>= 12 weeks

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 for angiosarcoma, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study
• Received palliative radiation 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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Study Officials

• Vinod Ravi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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 23, 2021
• First Posted: August 30, 2021
• Study Start: August 23, 2021
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)