Trial Outcomes & Findings for Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study (NCT NCT05017103)

Last Updated: 2024-12-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

At 12 weeks

Results posted on

2024-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sintilimab) 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.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Sintilimab) 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.
Overall Study Death	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sintilimab) n=6 Participants 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. Sintilimab: Given IV
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 weeks

Population: 2 participants not evaluable at 12 weeks (passed away)

Outcome measures

Outcome measures
Measure	Treatment (Sintilimab) n=4 Participants 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. Sintilimab: Given IV
Best Overall Response Rate Progressive Disease	3 Participants
Best Overall Response Rate Stable Disease	1 Participants

Adverse Events

Treatment (Sintilimab)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sintilimab) n=6 participants at risk 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. Sintilimab: Given IV
Respiratory, thoracic and mediastinal disorders Lung infection	16.7% 1/6 • Number of events 6 • Up to 9 months plus 90 days
Musculoskeletal and connective tissue disorders Spinal fracture	16.7% 1/6 • Number of events 6 • Up to 9 months plus 90 days
General disorders Febrile neutropenia	16.7% 1/6 • Number of events 6 • Up to 9 months plus 90 days
Gastrointestinal disorders Colitis	16.7% 1/6 • Number of events 6 • Up to 9 months plus 90 days
General disorders Disease progression	16.7% 1/6 • Number of events 6 • Up to 9 months plus 90 days

Other adverse events

Adverse event data not reported

Additional Information

Neeta Somaiah, MD

M D Anderson Cancer Center

Phone: 713-792-3626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place