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NCT04277663
The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
Phase 3 trial testing IBI310+IBI308 in Acral Melanoma That Has Been Removed by Surgery in 136 participants. Terminated before completion.
28 February 2023
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 17 April 2020 |
| Primary completion | 28 February 2023 |
| Estimated completion | 28 February 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- IBI310+IBI308 — full drug profile →
- IBI308 — full drug profile →
- High-dose recombinant interferon a-2B — full drug profile →
Conditions studied
- Acral Melanoma That Has Been Removed by Surgery — all drugs for Acral Melanoma That Has Been Removed by Surgery →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — full company profile →
Who can join
18 and older, any sex, with Acral Melanoma That Has Been Removed by Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476 -
Immunotherapy in Acral and Mucosal Melanoma: Current Status and Future Directions.
Mao L, Qi Z, Zhang L, Guo J, et al · · 2021 · cited 119× · PMID 34149718 · DOI 10.3389/fimmu.2021.680407 -
Acral melanoma: new insights into the immune and genomic landscape.
Carvalho LAD, Aguiar FC, Smalley KSM, Possik PA. · · 2023 · cited 21× · PMID 37913653 · DOI 10.1016/j.neo.2023.100947 -
Immune Checkpoint Inhibitors in Advanced Acral Melanoma: A Systematic Review.
Zheng Q, Li J, Zhang H, Wang Y, et al · · 2020 · cited 21× · PMID 33344255 · DOI 10.3389/fonc.2020.602705
Verify or expand the search:
- PubMed search for NCT04277663
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Innovent Biologics (Suzhou) Co. Ltd. trials
Trials by the same sponsor.
- NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
- NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
- NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
- NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
- NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · 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 NCT04277663 (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 Innovent Biologics (Suzhou) Co. Ltd.
- Last refreshed: 9 March 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/NCT04277663.
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