Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft … (NCT03590210) | Clinical Trial Compass
CompletedPhase 2
Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas
Germany92 participantsStarted 2018-06-08
Plain-language summary
The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have histologically confirmed soft tissue sarcoma (STS) other than liposarcoma or leiomyosarcoma (GIST excluded)
✓. ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy (anthracycline-containing regimen)
✓. Signed Written Informed Consent
✓. Men and women aged ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
✓. Measurable disease (according to RECIST criteria version 1.1)
✓. Locally advanced/unresectable or metastatic disease
✓. No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Exclusion criteria
✕. Prior exposure to trabectedin
✕. Active known or suspected autoimmune disease (e.g. autoimmune colitis, autoimmune panhypopituitarism, autoimmune adrenal insufficiency)
✕. Patients with human immunodeficiency virus (HIV) infection are excluded unless cluster of differentiation (CD)4+ cells are \> 350 and no viral load is detectable
✕. Symptomatic, untreated, or uncontrolled brain metastases present
What they're measuring
1
progression free survival rate at 6 months - PFSR6
Timeframe: after 6 months of treatment
2
safety, as measured by: - Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths - Incidence of clinical laboratory test abnormalities
Timeframe: through study completion, an average of 24 months
✕. Known significant chronic liver disease, such as cirrhosis or active hepatitis B or C
✕. Known active pulmonary disease with hypoxia defined as:
✕. Systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration
✕. Myocardial infarct within 6 months before enrollment, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities