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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

Terminated Phase 3 Last updated 9 March 2023
What this trial tests

Phase 3 trial testing IBI310+IBI308 in Acral Melanoma That Has Been Removed by Surgery in 136 participants. Terminated before completion.

Timeline
17 April 2020
Primary endpoint
28 February 2023
28 February 2023

Quick facts

Lead sponsorInnovent Biologics (Suzhou) Co. Ltd.
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment136
Start date17 April 2020
Primary completion28 February 2023
Estimated completion28 February 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. Antibodies to watch in 2021.
    Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
  2. 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
  3. 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
  4. 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

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Other Innovent Biologics (Suzhou) Co. Ltd. trials

Trials by the same sponsor.

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