Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT02676869
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-02-18', 'releaseDate': '2021-02-01'}], 'estimatedResultsFirstSubmitDate': '2021-02-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720328', 'term': 'soluble LAG-3 protein, human'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Study is an open label, dose finding study consisting of 2 parts. In part A, the dose is escalated following the protocol-defined safety observation period of the previous cohort. Patients will receive 9 cycles Pembrolizumab in combination with IMP321. In part B, the dose was defined based on the dose escalation. The treatment duration will be expanded to 19 cycles in the combined treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'From the time of inform consent form signature until 30 days after end of treatment'}, {'measure': 'To asses duration of adverse events', 'timeFrame': 'From the time of inform consent form signature until 30 days after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Best overall response rate (ORR) to irRC and RECIST 1.1', 'timeFrame': 'From the time of inform consent form signature until 30 days after end of treatment.'}, {'measure': 'Time to next treatment (TTNT)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 12 months'}, {'measure': 'Overall survival (part B only)', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage IV Melanoma', 'Stage III Melanoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria\n\n* Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma\n* 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\n* Female or male 18 years of age or above\n* ECOG performance status 0-1\n* Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria\n\nMain Exclusion Criteria\n\n* More than four prior lines of therapies for advanced or metastatic disease.\n* Prior PD-1/PDL-1 targeted therapy\n* Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug\n* 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\n* History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment\n* Known cerebral or leptomeningeal metastases\n* Serious intercurrent infection within 4 weeks prior to first dose of study treatment\n* Active acute or chronic infection\n* History or evidence of interstitial lung disease or active non-infectious pneumonitis\n* Active auto-immune disease requiring immunosuppressive therapy\n* HIV positivity, active hepatitis B or hepatitis C\n* Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment'}, 'identificationModule': {'nctId': 'NCT02676869', 'acronym': 'TACTI-mel', 'briefTitle': 'Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immutep Australia Pty. Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IMP321-P012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMP321 dose escalation', 'description': 'IMP321 administered fortnightly in addition to SOC pembrolizumab.', 'interventionNames': ['Drug: IMP321 (eftilagimod alpha)', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'IMP321 (eftilagimod alpha)', 'type': 'DRUG', 'otherNames': ['Eftilagimod alpha'], 'description': 'Part A: Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks\n\nPart B: Single subcutaneous injections of 30 mg of IMP321 administered every 2 weeks', 'armGroupLabels': ['IMP321 dose escalation']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Administered according to the approved label.', 'armGroupLabels': ['IMP321 dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane Womens Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4120', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Greenslopes Private Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3353', 'city': 'Ballarat', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Ballarat Hospital', 'geoPoint': {'lat': -37.56622, 'lon': 143.84957}}, {'zip': '3181', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6150', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immutep Australia Pty. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-02-01', 'type': 'RELEASE'}, {'date': '2021-02-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Immutep Australia Pty. Ltd.'}}}}