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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02211131




Registration number
NCT02211131
Ethics application status
Date submitted
5/08/2014
Date registered
7/08/2014

Titles & IDs
Public title
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
Scientific title
A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
Secondary ID [1] 0 0
2014-001146-13
Secondary ID [2] 0 0
20110266
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Talimogene Laherparepvec
Treatment: Surgery - Immediate surgical resection of melanoma lesion(s)

Other: Surgery - Surgical resection of melanoma tumor lesion(s)

Experimental: Talimogene Laherparepvec - Talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesion(s).


Treatment: Drugs: Talimogene Laherparepvec
Talimogene laherparepvec will be administered by intralesional injection into the injectable cutaneous, subcutaneous, and nodal tumors initially at a dose of 10\^6 plaque forming units (PFU)/mL at day 1 of week 1 followed by a dose of 10\^8 PFU/mL at day 1 (±3 days) of week 4, 6, 8, 10 and 12 or until all injectable tumors have disappeared, or intolerance of study treatment or in the opinion of the investigator, immediate surgical resection or any other treatment for melanoma is warranted, whichever occurs first.

Treatment: Surgery: Immediate surgical resection of melanoma lesion(s)
Surgical resection of melanoma tumor lesion(s) will be performed after randomization any time during weeks 1 to 6.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS)
Timepoint [1] 0 0
24 months after last participant was randomized (data cutoff date of 30 April 2019)
Secondary outcome [1] 0 0
RFS
Timepoint [1] 0 0
5 years after the last participant was randomized (last subject last visit occurred 28 April 2022)
Secondary outcome [2] 0 0
Kaplan-Meier (K-M) Estimate of RFS Rate at 1 Year, 2 Years, 3 Years, and 5 Years
Timepoint [2] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [3] 0 0
Histopathology Tumor-Free Margin (R0) Surgical Resection Rate
Timepoint [3] 0 0
18 weeks after last participant randomized (data cutoff date of 30 April 2019)
Secondary outcome [4] 0 0
Pathological Complete Response (pCR) Rate
Timepoint [4] 0 0
18 weeks after last participant randomized (data cutoff date of 30 April 2019)
Secondary outcome [5] 0 0
Local Recurrence-Free Survival (LRFS)
Timepoint [5] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [6] 0 0
Regional Recurrence-Free Survival (RRFS)
Timepoint [6] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [7] 0 0
Distant Metastases-Free Survival (DMFS)
Timepoint [7] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [8] 0 0
Overall Survival (Kaplan-Meier)
Timepoint [8] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [9] 0 0
Kaplan-Meier Estimate of OS at 1 Year, 2 Years, 3 Years, and 5 Years
Timepoint [9] 0 0
5 years after the last participant was randomized (last subject last visit occurred on 28 April 2022)
Secondary outcome [10] 0 0
Best Overall Tumor Response Per Investigator Response Rate (Talimogene Laherparepvec Arm Only)
Timepoint [10] 0 0
18 months after last participant randomized (data cutoff date of 30 April 2019).
Secondary outcome [11] 0 0
Lesion Objective Response Rate: Injected Lesions (Talimogene Laherparepvec Arm Only)
Timepoint [11] 0 0
18 months after last participant randomized (data cutoff date of 30 April 2019).
Secondary outcome [12] 0 0
Lesion Objective Response Rate: Uninjected Lesions (Talimogene Laherparepvec Arm Only)
Timepoint [12] 0 0
18 months after last participant randomized (data cutoff date of 30 April 2019).
Secondary outcome [13] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Fatal Adverse Events (AEs), and TEAEs Leading to Discontinuations or Interruptions
Timepoint [13] 0 0
Adverse Events are reported from first day of study drug or the surgery through 30 days after the last dose of study drug or 30 days after the surgery, whichever is later. Median duration of treatment was 11.14 weeks (range 0.1 to 12.3 weeks).
Secondary outcome [14] 0 0
Number of Participants With Talimogene Laherparepvec-Related TEAEs, SAEs, Fatal AEs, and TEAEs Leading to Discontinuations or Interruptions
Timepoint [14] 0 0
Adverse Events are reported from first day of study drug or the surgery through 30 days after the last administration of talimogene laherparepvec or 30 days after the surgical resection of melanoma tumor lesion(s), whichever is later.

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection.
* Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization.
* Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (= 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of = 10 mm.
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) = 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
* Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
* Subject must not have evidence of clinically significant immunosuppression or active herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic systemic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
* Subject known to have acute or chronic active hepatitis B, hepatitis C, or human immunodeficiency virus infection will also be excluded.
* Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.

Other criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/04/2022
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - North Sydney
Recruitment hospital [2] 0 0
Research Site - Woodville South
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
Brazil
State/province [15] 0 0
Santa Catarina
Country [16] 0 0
Brazil
State/province [16] 0 0
São Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio de Janeiro
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
Marseille cedex 05
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Pierre Benite Cedex
Country [22] 0 0
France
State/province [22] 0 0
Toulouse cedex 9
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Greece
State/province [24] 0 0
Heraklion - Crete
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint-Petersburg
Country [30] 0 0
Spain
State/province [30] 0 0
Andalucía
Country [31] 0 0
Spain
State/province [31] 0 0
Navarra
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Switzerland
State/province [33] 0 0
Chur
Country [34] 0 0
Switzerland
State/province [34] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02211131