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

NCT02738489 | Completed Phase 1 DMC

• 1 other identifier: SHR-1210-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

PD-1/PD-L1 Advanced Melanoma Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Adverse Events (AEs)

  The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010).

  From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)

• Number of Participants Experiencing Severe AEs (SAEs)

  The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010).

  From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)

Secondary Outcomes (16)

• Maximum Observed Serum Concentration (Cmax) For SHR-1210

  PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).

• Area Under the Serum Concentration-time Curve to infinite time (AUC 0-inf) for SHR-1210

  PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).

• Area Under the Serum Concentration-time Curve from dosing to the time of the last measured concentration (AUC 0-last) for SHR-1210

  PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).

• Time to Maximum Concentration (Tmax) for SHR-1210

  PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).

• Half-life (T½) for SHR-1210

  PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).

Study Arms (3)

Injection SHR-1210 60mg Cohort

EXPERIMENTAL

Biological: SHR-1210

Injection SHR-1210 200mg Cohort

EXPERIMENTAL

Biological: SHR-1210

Injection SHR-1210 400mg Cohort

EXPERIMENTAL

Biological: SHR-1210

Interventions

SHR-1210 BIOLOGICAL

A fully human monoclonal immunoglobulin (IgG4 subtype)

Injection SHR-1210 200mg Cohort; Injection SHR-1210 400mg Cohort; Injection SHR-1210 60mg Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• ECOG PS: 0-1.
• Life expectancy ≥ 12 weeks.
• With measurable and evaluable lesion(s) according to RECIST v1.1.

You may not qualify if:

• 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).
• 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.
• Patients who are known to be previously allergic to macromolecular protein preparations or any component of SHR-1210.
• 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.
• 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.
• 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).
• Patients with congenital or acquired immunodeficiency (such as HIV, HBV, or HCV).
• Patients who have previously received other PD-1 antibody treatments or immunotherapies targeting PD-1/PD-L1.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Affiliated to Beijing University

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 35596181 DERIVED

MeSH Terms

Interventions

camrelizumab

Study Officials

• Yiding Xing, Doctor

  Jiangsu Hengrui Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 14, 2016
• Study Start: April 13, 2016
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)