Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT04397770
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • SHR1210 — DRUG
    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
  • apatinib mesylate — DRUG
    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).
  • Temozolomide Injection — DRUG
    Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).

Study Details

It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.

Key Dates

Start date
May 31, 2020
Status verified
May 2020
Primary completion
Jun 30, 2022
Completion
Feb 28, 2023

Study Design

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

Arms

  • Experimental: Camre+Apa+TMZ

Primary Outcome Measure

ORR [ Time Frame: Through study uncompletion, an average of 1 year ]

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