PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma

Conditions

Melanoma

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.

Wang X, Wu X, Yang Y, Xu W, Tian H, Lian B, Chi Z, Si L, Sheng X, Kong Y, Zhou L, Mao L, Li S, Tang B, Yan X, Bai X, Guo J, Cui C.

2023-01-1219 citations

10.1016/j.ejca.2022.12.027

Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies

Hui Tian, Xuan Wang, Bin Lian, Xieqiao Yan, Lu Si et al. (15 authors)

Frontiers in Pharmacology2021-11-092 citations

10.3389/fphar.2021.747416

Apatinib in combination with camrelizumab, a humanized immunoglobulin G4 monoclonal antibody against programmed cell death-1, in patients with metastatic acral melanoma.

Xuan Wang, Chuanliang Cui, Bin Lian, Lu Si, Zhihong Chi et al. (14 authors)

Journal of Clinical Oncology2021-05-204 citations

10.1200/jco.2021.39.15_suppl.9539

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSHR1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

DRUGapatinib mesylate

apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
ORR	Time Frame: Through study completion, an average of 1 year	Objective Response Rate

Countries

China

Outcome results

None listed