OncoMatch/Clinical Trials/NCT06284590
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients
Is NCT06284590 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including L19IL2 and L19TNF for melanoma stage iii.
Treatment: L19IL2 · L19TNF · L19IL2/L19TNF · KEYTRUDA® — The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Melanoma
Disease stage
Required: Stage IIIB, IIIC, IIID, IVM1A, IVM1B, IVM1C, IVM1D (other)
Metastatic disease required
unresectable metastatic melanoma at stage III B, C, D or IV M1a (AJCC 8th ed.). Patients with Stage IVM1b, M1c and M1d oligometastatic disease [up to 10 visceral lesions in aggregate including lung, liver, bone or brain, with or without lymph node involvement], are eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 or anti-PD-L1 therapy
confirmed primary resistance to or acquired resistance on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies
Cannot have received: BRAF inhibitor and MEK inhibitor
Exception: patients with BRAF mutation must have received or declined BRAF/MEK inhibitors
Patients harboring the BRAF mutation who received BRAF/MEK inhibition (or declined BRAF/MEK inhibitors) and received thereafter anti-PD1 therapy showing resistance to such immunotherapy are eligible
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: transplant >5 years ago and no symptoms of GVHD
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years
Cannot have received: allogeneic tissue/solid organ transplant
Has had an allogeneic tissue/solid organ transplant
Lab requirements
Blood counts
adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Kidney function
adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Liver function
adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Have adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hartford Hospital · Hartford, Connecticut
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06284590 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BRAF inhibitor and MEK inhibitor, allogeneic hematopoietic stem cell transplantation, allogeneic tissue/solid organ transplant disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IIID or IVM1A or IVM1B or IVM1C or IVM1D is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages