Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Primary Purpose
Cutaneous Melanoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
Talimogene Laherparepvec
Sponsored by
About this trial
This is an interventional other trial for Cutaneous Melanoma
Eligibility Criteria
Inclusion Criteria:
- 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, renal and coagulation function
- Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
- Primary melanoma has been resected
- Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
- Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
- BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
- Signed, written informed consent
Exclusion Criteria:
- Cannot have metastatic (AJCC M1) disease
- No primary mucosal or uveal melanoma
- No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
- May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
- Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
- Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
Sites / Locations
- University of LouisvilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combination T-VEC/Pembrolizumab
Arm Description
Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors. Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
Outcomes
Primary Outcome Measures
Pathologic Complete Response
Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection
Secondary Outcome Measures
Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events
Adverse events and Serious Adverse Events will be collected
Full Information
NCT ID
NCT03842943
First Posted
February 7, 2019
Last Updated
July 16, 2022
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03842943
Brief Title
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Official Title
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.
Detailed Description
This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination T-VEC/Pembrolizumab
Arm Type
Experimental
Arm Description
Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab
T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors.
Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Preoperative infusions
Intervention Type
Drug
Intervention Name(s)
Talimogene Laherparepvec
Other Intervention Name(s)
T-VEC, Imlygic
Intervention Description
Preoperative intralesional injection
Primary Outcome Measure Information:
Title
Pathologic Complete Response
Description
Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events
Description
Adverse events and Serious Adverse Events will be collected
Time Frame
Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
ECOG performance status of 0 or 1
Adequate hematologic, hepatic, renal and coagulation function
Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
Primary melanoma has been resected
Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
Signed, written informed consent
Exclusion Criteria:
Cannot have metastatic (AJCC M1) disease
No primary mucosal or uveal melanoma
No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Egger, MD
Phone
502-629-6950
Email
michael.egger@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Egger, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Baum
Phone
502-562-4370
Email
mary.baum@louisville.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
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