UnknownPhase 2

Paclitaxel-Avelumab for Angiosarcoma

South Korea32 participantsStarted 2018-06-01

Plain-language summary

To investigate the efficacy of Avelumab when given in combination with paclitaxel as a first line treatment for the patients with inoperable angiosarcoma.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent.
✓. Male or female subjects aged ≥ 20 years.
✓. Histologically or cytologically proven metastatic or locally advanced Angiosarcoma.
✓. Inoperable Angiosarcoma
✓. Chemo-naïve patient
✓. ECOG performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
✓. Disease must be measurable with at least 1 measurable lesion by RECIST 1.1
✓. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).

Exclusion criteria

✕. Concurrent treatment with a non-permitted drug (see Section 14)
✕. Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody.
✕. Concurrent anticancer treatment within 28 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy \[with the exception of palliative bone directed radiotherapy\], immune therapy, or cytokine therapy except for erythropoietin)
✕. Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
✕. Use of hormonal agents within 7 days before the start of trial treatment.
✕. Use of any investigational drug within 28 days before the start of trial treatment.
✕. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of patients with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily). Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
✕. Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.

What they're measuring

Overall response rate

Timeframe: up to 6 months

Trial details

NCT IDNCT03512834

SponsorSung Yong Oh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11

Contact for this trial

SUNG YONG OH, MD

+82-51-240-2808 drosy@dau.ac.kr

View on ClinicalTrials.gov More Angiosarcoma Metastatic trials