search
Back to results

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
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cutaneous Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 7, 2019
Last Updated
July 16, 2022
Sponsor
University of Louisville
search

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

We'll reach out to this number within 24 hrs