Clinical trial · Interventional
FLX475 in Combination With Ipilimumab in Advanced Melanoma
Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced 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): Change in clinical landscape
Summary
Brief summary (as posted)
This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent. The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLX475 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLX475 and ipilimumab combination therapy
- description
- Participants received FLX475 tablets orally and ipilimumab by IV infusions
- interventionNames
- Drug: FLX475
- Drug: Ipilimumab
Primary outcomes (3)
- measure
- Objective Response Rate
- timeFrame
- Approximately 1 year
- description
- To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent
- measure
- Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
- timeFrame
- Approximately 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IV or unresectable Stage III advanced melanoma * Prior treatment with at least 2 months of anti-PD-(L)1 agent * Measurable disease at baseline * Tumor available for biopsy Exclusion Criteria: * History of allergy or severe hypersensitivity to biologic agents * History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy * Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
References
Publications (0)
Data not yet available