A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 in Patients With Advanced Melanoma

NCT ID: NCT02738489

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-13
• Study Completion Date: 2020-01-08

Brief Summary

This is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced melanoma with disease progression after standard treatment, unresectable lesions, or metastases. Between Apr 13, 2016, and Jan 8, 2020, 36 patients were enrolled from Beijing Cancer Hospital.

Conditions

Advanced Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injection SHR-1210 60mg Cohort

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: BIOLOGICAL

A fully human monoclonal immunoglobulin (IgG4 subtype)

Injection SHR-1210 200mg Cohort

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: BIOLOGICAL

A fully human monoclonal immunoglobulin (IgG4 subtype)

Injection SHR-1210 400mg Cohort

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: BIOLOGICAL

A fully human monoclonal immunoglobulin (IgG4 subtype)

Interventions

SHR-1210

A fully human monoclonal immunoglobulin (IgG4 subtype)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged 18-70 years old, who agree to provide pathological tumor biopsy specimens during the screening period and after the end of treatment.

2. Patients with pathologically confirmed advanced melanoma who have failed standard treatments or without effective treatment methods (e.g., chemotherapy, targeted therapy and immunotherapy other than those targeting PD-1/PD-L1).

3. ECOG PS: 0-1.

4. Life expectancy ≥ 12 weeks.

5. With measurable and evaluable lesion(s) according to RECIST v1.1.

Exclusion Criteria

1. Patients with active autoimmune diseases or a history of autoimmune diseases (including but not limited to the following: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism; adults with vitiligo or completely relieved childhood asthma can be enrolled if they do not require any intervention; patients with asthma requiring medical intervention with bronchodilators cannot be enrolled).

2. Patients who are currently using immunosuppressive agents, or systemic or absorbable local hormonal therapies for immunosuppression purposes (> 10 mg/day prednisone or equivalent) and still use the above drugs within 2 weeks prior to enrollment.

3. Patients who are known to be previously allergic to macromolecular protein preparations or any component of SHR-1210.

4. Patients with clinically symptomatic metastases to central nervous system (e.g., cerebral edema requiring hormonal intervention, or progression of brain metastasis). Patients who have received treatment for brain or meningeal metastasis can be included if they are clinically stable (MRI) for at least 2 months and have discontinued systemic hormonal therapy (> 10 mg/day prednisone or equivalent) for more than 2 weeks.

5. Patients who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy with an interval of less than 4 weeks from the completion of the treatment to the study medication (for patients who have previously received chemotherapy with nitrosourea or mitomycin, the interval from the end of chemotherapy to the study enrollment is less than 6 weeks); patients whose adverse events caused by previous treatments have not recovered to CTCAE Grade ≤ 1.

6. Patients with active infection or unexplained fever > 38.5 °C during screening or prior to the first dose (patients with tumor-induced fever may be enrolled as per the judgment of the investigator).

7. Patients with congenital or acquired immunodeficiency (such as HIV, HBV, or HCV).

8. Patients who have previously received other PD-1 antibody treatments or immunotherapies targeting PD-1/PD-L1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yiding Xing, Doctor

Role: STUDY_DIRECTOR

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Locations

Cancer Hospital Affiliated to Beijing University

Beijing, Beijing Municipality, China

Countries

China

References

Zhou L, Wu X, Chi Z, Si L, Sheng X, Kong Y, Mao L, Lian B, Tang B, Yan X, Wang X, Bai X, Li S, Wei X, Li J, Yang Q, Guo J, Cui C. Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study. BMC Cancer. 2022 May 20;22(1):565. doi: 10.1186/s12885-022-09663-5.

Reference Type: DERIVED

PMID: 35596181 (View on PubMed)

Other Identifiers

SHR-1210-102

Identifier Type: -

Identifier Source: org_study_id