PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma (NCT03955354) | Clinical Trial Compass
UnknownPhase 2
PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
China30 participantsStarted 2019-03-05
Plain-language summary
the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Has not received any systematic anti-tumor drug treatment.
✓. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
✓. ECOG 0-1.
✓. Adequate organ function.
✓. Life expectancy of greater than 12 weeks.
✓. Patient has given written informed consent.
Exclusion criteria
✕. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
✕. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
✕. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
✕. Subjects with any active autoimmune disease or history of autoimmune disease
✕. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
What they're measuring
1
ORR
Timeframe: Time Frame: Through study completion, an average of 1 year
Trial details
NCT IDNCT03955354
SponsorPeking University Cancer Hospital & Institute
✕. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
✕. Received a live vaccine within 4 weeks of the first dose of study medication.