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

Phase 2

• Conditions: Melanoma
• Interventions: Drug: SHR1210; Drug: apatinib mesylate; Drug: Temozolomide Injection

• Registration Number: NCT04397770
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21
• Primary Completion: 2022-06
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camre+Apa+TMZ	SHR1210	-
Camre+Apa+TMZ	apatinib mesylate	-
Camre+Apa+TMZ	Temozolomide Injection	-

Primary Outcome Measures

Name	Time	Method
ORR	Through study uncompletion, an average of 1 year	Objective Response Rate