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NCT02738489
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 in Patients With Advanced Melanoma
Phase 1 trial testing SHR-1210 in Advanced Melanoma in 36 participants. Completed in 8 January 2020.
8 January 2020
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 13 April 2016 |
| Primary completion | 8 January 2020 |
| Estimated completion | 8 January 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-1210 — full drug profile →
Conditions studied
- Advanced Melanoma — all drugs for Advanced Melanoma →
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):
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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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02738489
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR-1210
Trials testing the same drug.
- NCT05799183 — A SHR-1210 BE Study on Healthy Subjects · Phase 1 · terminated
- NCT04533490 — A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · unknown
- NCT04680988 — A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer · Phase 2 · completed
- NCT04790539 — a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer · Phase 2 · unknown
- NCT04506242 — Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer · Phase 2 · unknown
Other recruiting trials for Advanced Melanoma
Currently open trials in the same condition.
- NCT07310784 — A Phase II Trial of LM103 in Advanced Melanoma · Phase 2 · recruiting
- NCT07099430 — A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma · Phase 1, PHASE2 · recruiting
- NCT05629546 — Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on C · Phase 1 · recruiting
- NCT06264180 — VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] · Phase 3 · recruiting
- NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial · NA · recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02738489 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 28 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02738489.
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