protocolSection identificationModule nctId: NCT06284590, orgStudyIdInfo id: PH-ICKPD1-02/21, secondaryIdInfos id: MK-3475-F20, type: OTHER, domain: Merck Sharp & Dohme LLC, secondaryIdInfos id: KEYNOTE-F20, type: OTHER, domain: missing, briefTitle: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients, acronym: INTACT/MeRCI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Philogen S.p.A., class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: 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., conditionsModule conditions: Melanoma Stage III, conditions: Melanoma Stage IV, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 162 patients. Patients enrolled will be randomized in a 1:1:1 ratio. i) systemic pembrolizumab in combination with intralesional L19IL2 (Arm 1): 54 patients.ii) systemic pembrolizumab in combination with intralesional L19TNF (Arm 2): 54 patients iii) systemic pembrolizumab in combination with intralesional L19IL2/L19TNF (Arm 3): 54 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: L19IL2, interventions name: L19TNF, interventions name: L19IL2/L19TNF, interventions name: KEYTRUDA®, outcomesModule primaryOutcomes measure: Confirmed Objective Response Rate (ORR), secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Pathological response, secondaryOutcomes measure: Confirmed ORR, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Serious Adverse Event (SAEs), secondaryOutcomes measure: Drug-Induced Liver Injury (DILI), secondaryOutcomes measure: Number of patients with Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Number of patients with Immune-Related Adverse Events (IRAEs), secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal coagulation laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal body temperature, secondaryOutcomes measure: Number of participants with abnormal blood pressure, secondaryOutcomes measure: Number of participants with abnormal Electrocardiogram (ECG) readings, secondaryOutcomes measure: Number of participants with abnormal Echocardiogram (ECHO) readings, secondaryOutcomes measure: Number of participants with abnormal physical examination results, secondaryOutcomes measure: Concomitant medication usage, secondaryOutcomes measure: Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False