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

Peking University Cancer Hospital & Institute

Status and phase: Unknown; Phase 2

Conditions: Melanoma

Treatments: Drug: apatinib mesylate; Drug: SHR1210; Drug: Temozolomide Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04397770

MA-MM-II-002

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Camre+Apa+TMZ

Experimental group

Treatment:

Drug: SHR1210

Drug: Temozolomide Injection

Drug: apatinib mesylate