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NCT02738489

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

Completed Phase 1 Last updated 28 February 2023
What this trial tests

Phase 1 trial testing SHR-1210 in Advanced Melanoma in 36 participants. Completed in 8 January 2020.

Timeline
13 April 2016
Primary endpoint
8 January 2020
8 January 2020

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date13 April 2016
Primary completion8 January 2020
Estimated completion8 January 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Advanced Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Crystal clear: visualizing the intervention mechanism of the PD-1/PD-L1 interaction by two cancer therapeutic monoclonal antibodies.
    Tan S, Chen D, Liu K, He M, et al · · 2016 · cited 33× · PMID 27815822 · DOI 10.1007/s13238-016-0337-7
  2. Association of NRAS Mutation With Clinical Outcomes of Anti-PD-1 Monotherapy in Advanced Melanoma: A Pooled Analysis of Four Asian Clinical Trials.
    Zhou L, Wang X, Chi Z, Sheng X, et al · · 2021 · cited 27× · PMID 34290710 · DOI 10.3389/fimmu.2021.691032
  3. Population pharmacokinetics of the anti-PD-1 antibody camrelizumab in patients with multiple tumor types and model-informed dosing strategy.
    Wang CY, Sheng CC, Ma GL, Xu D, et al · · 2021 · cited 12× · PMID 33154554 · DOI 10.1038/s41401-020-00550-y
  4. Risk Models for Advanced Melanoma Patients Under Anti-PD-1 Monotherapy-<i>Ad hoc</i> Analyses of Pooled Data From Two Clinical Trials.
    Bai X, Dai J, Li C, Cui C, et al · · 2021 · cited 11× · PMID 34094921 · DOI 10.3389/fonc.2021.639085
  5. Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study.
    Zhou L, Wu X, Chi Z, Si L, et al · · 2022 · cited 7× · PMID 35596181 · DOI 10.1186/s12885-022-09663-5
  6. Ongoing Phase I Studies of Immune Checkpoint Inhibitors in China.
    Fang W, Zhao S, Zhang Y, Ma Y, et al · · 2019 · cited 3× · PMID 30819827 · DOI 10.1634/theoncologist.2019-io-s1-s03

Verify or expand the search:

Other trials of SHR-1210

Trials testing the same drug.

Other recruiting trials for Advanced Melanoma

Currently open trials in the same condition.

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

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