Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma

NCT04331093 | Recruiting Phase 2

• 1 other identifier: k2020033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive value for efficiency of several biomarkers.

Conditions

Acral Melanoma

Outcome Measures

Primary Outcomes (1)

• pCR

  Pathological complete response rate

  3 months

Secondary Outcomes (3)

• npCR

  3 months

• ORR

  3 months

• 3 Year RFS

  3 years

Study Arms (1)

resectable stage III-IV Acral melanoma

EXPERIMENTAL

Drug: SHR-1210+Apatinib

Interventions

SHR-1210+Apatinib DRUG

Drug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression

resectable stage III-IV Acral melanoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years. 2. Clinically diagnosed or pathologically diagnosed, resectable stage III-IV Acral melanoma with at least one measurable lesion that has not been treated locally (according to RECISTv1.1, this measurable lesion is spiral CT (Or MRI scan with a long diameter ≥10mm or an enlarged lymph node with a short diameter ≥15mm), patients with metastasis can also be enrolled; 3. Have not received any anti-tumor medication before. 4. ECOG score is 0 or 1. 5. Tumor tissue specimens must be provided for genetic testing (preoperative biopsy / intraoperative tissue removal).
• \. Expected survival time ≥ 12 weeks. 7. The level of organ function must meet the following requirements (7 days before randomization):
• Peripheral blood: absolute neutrophil count (≥) 1.5 × 109 / L, platelet count (≥) 100 × 109 // L, hemoglobin (Hb) ≥9g / dL (no blood transfusion within 14 days before detection);
• Liver: serum total bilirubin (≤) 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or AST, ALT ≤ 5 × ULN);
• Serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50mL / min (using Cockcroft-Gault formula); ④. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (only applicable to patients who have not received anticoagulant therapy and received anticoagulant therapy, and anticoagulant drugs should meet the treatment requirements);
• ⑤. Cardiac function is normal, that is, the result of ECG is normal or has no clinical significance. Left ventricular ejection fraction (LVEF) of cardiac ultrasound examination is\> 50%.
• \. Women of childbearing age must have a negative pregnancy test within 7 days before treatment; males of reproductive capacity or women who are at risk of pregnancy must use effective contraception throughout the study period and continue contraception for 3 months after the end of treatment.
• \. Can swallow pills normally. 10. Voluntarily participate in the research and sign the informed consent form, with good compliance and willingness to cooperate with the follow-up.

You may not qualify if:

• Patients who have been treated with anti-PD-1, anti-PD-L1, VEGFRTKI;
• Patients who are participating or are participating in clinical studies of other drugs or treatments, within 4 weeks before enrollment (prior to randomization);
• Patients who received major surgery, vaccines, and systemic hormone therapy within 4 weeks before the study began; and patients who received radiation therapy within 2 weeks;
• In the past 3 years, other malignancies other than acral or mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical cancer;
• Receive hematopoietic stimulating factors (such as granulocyte colony stimulating factor (G-CSF) and erythropoietin) within 1 week before the start of the study.
• HIV positive test;
• Patients with active hepatitis B or C:
• ①. In the case of HBsAg or HBcAb positive, additional HBVDNA testing (results above the lower limit of detection specified by the study site).
• ②. In the case of HCV antibody positive, perform additional HCVRNA detection.
• Urine routine indicates urinary protein ≥ ++ and it has been confirmed that the amount of urinary protein in 24 hours is\> 1.0g;
• Suffering from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• Pleural effusion or ascites with clinical symptoms and symptomatic treatment;
• People with ocular shape and central nervous system (CNS) metastasis;
• Have a history of active tuberculosis;
• Have any uncontrollable clinical problems, including but not limited to:

Sponsors & Collaborators

• Di Wu: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Central Study Contacts

Di Wu, MD

CONTACT

13944888991; Wudi991202@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

CN (1)