NCT04397770

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2020

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

May 18, 2020

Last Update Submit

May 18, 2020

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective Response Rate

    Through study uncompletion, an average of 1 year

Study Arms (1)

Camre+Apa+TMZ

EXPERIMENTAL
Drug: SHR1210Drug: apatinib mesylateDrug: Temozolomide Injection

Interventions

SHR1210DRUG

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

Camre+Apa+TMZ
apatinib mesylateDRUG

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).

Camre+Apa+TMZ
Temozolomide InjectionDRUG

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).

Camre+Apa+TMZ

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mao L, Lian B, Li C, Bai X, Zhou L, Cui C, Chi Z, Sheng X, Wang X, Tang B, Yan X, Li S, Kong Y, Dai J, Wei X, Li J, Duan R, Xu H, Wu X, Yang Y, Cheng F, Zhang C, Xia F, Pang Z, Guo J, Si L. Camrelizumab Plus Apatinib and Temozolomide as First-Line Treatment in Patients With Advanced Acral Melanoma: The CAP 03 Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2023 Aug 1;9(8):1099-1107. doi: 10.1001/jamaoncol.2023.1363.

    PMID: 37261804DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

camrelizumabapatinibTemozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Peking University Cancer Hospital

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

May 1, 2020

Primary Completion

June 1, 2022

Study Completion

February 1, 2023

Last Updated

May 21, 2020

Record last verified: 2020-05