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 (May 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
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF mutation
Disease stage
Required: Stage IIIB, IIIC, IIID, IV M1A, IV M1B, IV M1C, IV M1D (AJCC 8th ed.)
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 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 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. PD-1 treatment progression is defined by meeting all of the following criteria: a.) Has received at least 2 doses of an approved anti-PD-1/L1 mAb. b.) Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. c.) Progressive disease has been documented within 12 weeks from the last dose of anti- PD-1/L1 mAb.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Exception: excluded only if discontinued due to Grade 3 or higher immune-related adverse event
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.
Cannot have received: systemic anti-cancer therapy
Exception: allowed if >4 weeks since last dose
Has received prior systemic anti-cancer therapy including investigational agents or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Cannot have received: radiotherapy
Exception: allowed if >2 weeks since last dose (or 1 week for palliative radiation to non-CNS disease)
Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: allowed if >5 years ago and no symptoms of GVHD
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD).
Cannot have received: allogeneic tissue/solid organ transplant
Has had an allogeneic tissue/solid organ transplant.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
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