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

Sponsor
Di Wu
Study ID
NCT04331093
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acral Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
May 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: resectable stage III-IV Acral melanoma

Primary Outcome Measure

pCR [ Time Frame: 3 months ]

Central Contacts

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