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NCT03178123
The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery
Phase 2 trial testing humanized anti-PD-1 monoclonal antibody Toripalimab in Mucosal Melanoma in 220 participants. Status unknown.
30 April 2022
Quick facts
| Lead sponsor | Shanghai Junshi Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 31 May 2017 |
| Primary completion | 30 April 2022 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- humanized anti-PD-1 monoclonal antibody Toripalimab — full drug profile →
- high-dose recombinant interferon a-2B — full drug profile →
Conditions studied
- Mucosal Melanoma — all drugs for Mucosal Melanoma →
Sponsor
Shanghai Junshi Bioscience Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Mucosal Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Characterization of cancer genomic heterogeneity by next-generation sequencing advances precision medicine in cancer treatment.
Zhang J, Späth SS, Marjani SL, Zhang W, et al · · 2018 · cited 90× · PMID 30687561 · DOI 10.1093/pcmedi/pby007 -
Programmed cell death-ligand 2: A neglected but important target in the immune response to cancer?
Solinas C, Aiello M, Rozali E, Lambertini M, et al · · 2020 · cited 61× · PMID 32622310 · DOI 10.1016/j.tranon.2020.100811 -
The Current State of Treatment and Future Directions in Cutaneous Malignant Melanoma.
Ernst M, Giubellino A. · · 2022 · cited 49× · PMID 35453572 · DOI 10.3390/biomedicines10040822 -
Vulvar Melanoma: Molecular Characteristics, Diagnosis, Surgical Management, and Medical Treatment.
Wohlmuth C, Wohlmuth-Wieser I. · · 2021 · cited 38× · PMID 34125416 · DOI 10.1007/s40257-021-00614-7 -
Emerging strategies to treat rare and intractable subtypes of melanoma.
Alicea GM, Rebecca VW. · · 2021 · cited 30× · PMID 32274887 · DOI 10.1111/pcmr.12880 -
Molecular Profiling and Novel Therapeutic Strategies for Mucosal Melanoma: A Comprehensive Review.
Indini A, Roila F, Grossi F, Massi D, et al · · 2021 · cited 19× · PMID 35008570 · DOI 10.3390/ijms23010147 -
Insights and Strategies of Melanoma Immunotherapy: Predictive Biomarkers of Response and Resistance and Strategies to Improve Response Rates.
Seyhan AA, Carini C. · · 2022 · cited 12× · PMID 36613491 · DOI 10.3390/ijms24010041 -
Advances in immunotherapy for mucosal melanoma: harnessing immune checkpoint inhibitors for improved treatment outcomes.
Shan Z, Liu F. · · 2024 · cited 9× · PMID 39234260 · DOI 10.3389/fimmu.2024.1441410
Verify or expand the search:
- PubMed search for NCT03178123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mucosal Melanoma
Currently open trials in the same condition.
- NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
- NCT07400302 — Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery · Phase 2 · recruiting
- NCT05111574 — Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery · Phase 2 · recruiting
- NCT05086692 — A Beta-only IL-2 ImmunoTherapY Study · Phase 1, PHASE2 · recruiting
- NCT04645680 — Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic · Phase 2 · active not recruiting
Other Shanghai Junshi Bioscience Co., Ltd. trials
Trials by the same sponsor.
- NCT07503756 — JS212 Combination Therapies in Metastatic Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07484724 — A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Ce · Phase 2 · not yet recruiting
- NCT07518160 — JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study · Phase 2 · not yet recruiting
- NCT07309276 — A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer · Phase 2 · not yet recruiting
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 NCT03178123 (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 Shanghai Junshi Bioscience Co., Ltd.
- Last refreshed: 30 September 2020
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/NCT03178123.
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