Description:
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.
Title
- Brief Title: Neoadjuvant Combination Immunotherapy for Stage III Melanoma
- Official Title: Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Clinical Trial IDs
- ORG STUDY ID:
181095
- NCT ID:
NCT03842943
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | Keytruda | Combination T-VEC/Pembrolizumab |
Talimogene Laherparepvec | T-VEC, Imlygic | Combination T-VEC/Pembrolizumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Combination T-VEC/Pembrolizumab | Experimental | 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. | - Pembrolizumab
- Talimogene Laherparepvec
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathologic Complete Response |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection |
Secondary Outcome Measures
Measure: | Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events |
Time Frame: | Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years |
Safety Issue: | |
Description: | Adverse events and Serious Adverse Events will be collected |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Louisville |
Last Updated
July 2, 2021