soft tissue sarcoma
Conditions
Interventions
IMP administration
Sponsors
Ogawa Shintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written report from the trial central laboratory indicating TP53 wild-type status - One prior systemic regimen for advanced disease with documented progressive disease as per serial radiologic imaging - Patient willing to donate mandatory blood and tissue samples for the pharmacokinetics (PK), pharmacodynamics, and biomarker analyses (unless exemptions apply) - Presence of at least one target lesion according to RECIST Version 1.1 - Male or female patients >=18 years old - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Adequate organ function
Exclusion criteria
Exclusion criteria: - Prior treatment with immunotherapy in the context of anticancer therapy - Previous or concomitant malignancies other than the one treated in this trial within the previous 2 years, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or other malignancy that is considered cured by local treatment - Any history or presence of uncontrolled gastrointestinal tract (GIT) disorders that could affect the intake and/or absorption of the trial drug (e.g., nausea, vomiting, Crohns disease, ulcerative colitis, chronic diarrhea, malabsorption) in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, OS | — |
Secondary
| Measure | Time frame |
|---|---|
| OR, DOR, DC | — |
Countries
Germany, Japan
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed