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

Melanoma Clinical Trial

Official title:

Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma：a Single-center, Exploratory Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04397770
• Other study ID #: MA-MM-II-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2020
• Est. completion date: February 2023

Study information

• Verified date: May 2020
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• SHR1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
• apatinib mesylate
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
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	Through study uncompletion, an average of 1 year