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NCT05017103

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

Terminated Phase 2 Results posted Last updated 11 December 2024
What this trial tests

Phase 2 trial testing Sintilimab in Locally Advanced Undifferentiated Pleomorphic Sarcoma in 6 participants. Terminated before completion.

Timeline
13 July 2021
Primary endpoint
20 February 2024
20 February 2024

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date13 July 2021
Primary completion20 February 2024
Estimated completion20 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Undifferentiated Pleomorphic Sarcoma or Metastatic Undifferentiated Pleomorphic Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Best Overall Response Rate Primary · At 12 weeks

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.

Progressive Disease
GroupValue95% CI
Treatment (Sintilimab)3
Stable Disease
GroupValue95% CI
Treatment (Sintilimab)1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 9 months plus 90 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Sintilimab)
Serious: 2/6 (33%)
Deaths: 4/6

Serious adverse events (5 terms)

ReactionSystemTreatment (Sintilimab)
Lung infectionRespiratory, thoracic and mediastinal disorders
Spinal fractureMusculoskeletal and connective tissue disorders
Febrile neutropeniaGeneral disorders
ColitisGastrointestinal disorders
Disease progressionGeneral disorders

Most-reported serious reactions: Lung infection, Spinal fracture, Febrile neutropenia, Colitis, Disease progression.

Data from ClinicalTrials.gov NCT05017103 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

Other recruiting trials for Locally Advanced Undifferentiated Pleomorphic Sarcoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05017103.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing