Clinical trial · Interventional
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
NCT02676869CI-TRIAL-00042413TACTI-melcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMP321 (eftilagimod alpha) | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMP321 dose escalation
- description
- IMP321 administered fortnightly in addition to SOC pembrolizumab.
- interventionNames
- Drug: IMP321 (eftilagimod alpha)
- Drug: Pembrolizumab
Primary outcomes (4)
- measure
- To assess the recommended phase 2 dose
- timeFrame
- From the time of inform consent form signature until 30 days after end of treatment
- measure
- To asses frequency of adverse events
- timeFrame
- From the time of inform consent form signature until 30 days after end of treatment
- measure
- To asses severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria * Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma * Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to study start * Female or male 18 years of age or above * ECOG performance status 0-1 * Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria Main Exclusion Criteria * More than four prior lines of therapies for advanced or metastatic disease. * Prior PD-1/PDL-1 targeted therapy * Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug * Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment * History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment * Known cerebral or leptomeningeal metastases * Serious intercurrent infection within 4 weeks prior to first dose of study treatment * Active acute or chronic infection * History or evidence of interstitial lung disease or active non-infectious pneumonitis * Active auto-immune disease requiring immunosuppressive therapy * HIV positivity, active hepatitis B or hepatitis C * Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.