Clinical trial · Interventional
A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Strategy
Summary
Brief summary (as posted)
This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cutaneous Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Unresectable Cutaneous Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab + IBI110 | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm 1
- description
- Sintilimab is a recombinant fully human anti-programmed cell death protein 1 (PD-1) monoclonal antibody, and IBI110 is a recombinant fully human anti-lymphocyte activation gene 3 (LAG3) monoclonal antibody. Sintilimab (IBI308) will be administered intravenously (IV) in combination with IBI110 administered intravenously (IV) every 3-weeks (Q3W).
- interventionNames
- Combination Product: Sintilimab + IBI110
Primary outcomes (4)
- measure
- To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)
- timeFrame
- Up to 28 months
- description
- Incidence and severity of Adverse Events (AEs) and laboratory abnormalities
- measure
- To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults, age 18 years or older 2. Histologically confirmed unresectable or metastatic cutaneous melanoma 3. Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent 4. Available tumor tissue OR be willing to provide a fresh tumor biopsy 5. Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 7. Adequate organ and bone marrow function Exclusion Criteria: 1. Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products 2. Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials 3. Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1 4. Known symptomatic/active untreated central nervous system (CNS) metastasis 5. Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy 6. Inadequate recovery from all recent surgeries 7. At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery 8. Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study) 9. History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load) 10. Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody) 11. Documented history or current diagnosis of clinically significant cardiac disease 12. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy 13. Received solid organ or bone marrow transplantation 14. History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease 15. Active or previously documented autoimmune disease including but not limited to inflammatory bowel disease, diverticulitis, celiac disease, systemic lupus erythematosus, Wegener syndrome, multiple sclerosis, and vasculitis 16. Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose 17. Active gastrointestinal (GI) bleeding or GI perforation or fistula 18. Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry 19. Pregnant or lactating women or women who intend to get pregnant or lactate during the study and up to 120 days after the end of treatment
References
Publications (0)
Data not yet available