Clinical trial NCT03955354: PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Official title: A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. 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;
6. 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);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in charge.

Primary outcomes:
measure: ORR
timeFrame: Time Frame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guo Jun
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References:
citation: Tian H, Wang X, Lian B, Yan X, Si L, Chi Z, Sheng X, Kong Y, Mao L, Bai X, Tang B, Li S, Zhou L, Cui C, Guo J. Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies. Front Pharmacol. 2021 Nov 9;12:747416. doi: 10.3389/fphar.2021.747416. eCollection 2021.