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A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

Primary Purpose

Melanoma, Merkel Cell Carcinoma, Other Solid Tumors

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring T-VEC (Talimogene Laherparepvec), Radiotherapy, 16-224

Eligibility Criteria

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

Inclusion Criteria:

  • Man or woman ≥ 18 years old
  • Life expectancy > 4 months
  • Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy
  • Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and > 10 mm in longest dimension

    ° Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5)

  • Metastasis that is > 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on PET/CT
  • Adequate coagulation function (platelet count >50 k/mcL, international normalized ratio of < 1.5)
  • Resolution or stabilization of clinically significant adverse events from prior therapy
  • Able to provide valid written informed consent

Exclusion Criteria:

  • Active herpetic skin lesions or prior complications of HSV-1 infection (such as herpetic keratitis, herpetic encephalitis)
  • Receipt of a therapeutic anticoagulant
  • Receipt of live vaccine within 28 days of planned first dose of TVEC
  • Receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study)

    ° Patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol

  • History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment
  • History of high grade (CTCAE ≥ Grade 3) immune mediated adverse event from prior cancer immunotherapy
  • History of CTCAE ≥ Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy
  • Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir)
  • Active or chronic hepatitis B or C infection

    ° Previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion

  • Known human immunodeficiency virus (HIV) infection
  • Known leukemia or lymphoma
  • Common variable immunodeficiency
  • Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of ≥ 10 mg)
  • Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients
  • High likelihood of protocol non-compliance (in opinion of investigator)
  • Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec
  • Woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec

Sites / Locations

  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy

Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy

Arm Description

Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10^8 pfu/mL.

Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.

Outcomes

Primary Outcome Measures

response
Overall subject level response is defined as partial or complete (>50% or greater decrease in largest lesion) by the modified World Health Organization (mWHO) criteria, and will include measurements of tumor size by CT component of PET/CT, and clinically by digital photography.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
February 7, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02819843
Brief Title
A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
Official Title
A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Amgen

4. Oversight

5. Study Description

Brief Summary
The purpose of this phase II clinical study is to test the good and bad effects of T-VEC (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Merkel Cell Carcinoma, Other Solid Tumors
Keywords
T-VEC (Talimogene Laherparepvec), Radiotherapy, 16-224

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy
Arm Type
Experimental
Arm Description
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10^8 pfu/mL.
Arm Title
Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy
Arm Type
Experimental
Arm Description
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
Intervention Type
Drug
Intervention Name(s)
TALIMOGENE LAHERPAREPVEC (TVEC)
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiotherapy
Primary Outcome Measure Information:
Title
response
Description
Overall subject level response is defined as partial or complete (>50% or greater decrease in largest lesion) by the modified World Health Organization (mWHO) criteria, and will include measurements of tumor size by CT component of PET/CT, and clinically by digital photography.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Man or woman ≥ 18 years old Life expectancy > 4 months Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and > 10 mm in longest dimension ° Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5) Metastasis that is > 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on PET/CT Adequate coagulation function (platelet count >50 k/mcL, international normalized ratio of < 1.5) Resolution or stabilization of clinically significant adverse events from prior therapy Able to provide valid written informed consent Exclusion Criteria: Active herpetic skin lesions or prior complications of HSV-1 infection (such as herpetic keratitis, herpetic encephalitis) Receipt of a therapeutic anticoagulant Receipt of live vaccine within 28 days of planned first dose of TVEC Receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study) ° Patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment History of high grade (CTCAE ≥ Grade 3) immune mediated adverse event from prior cancer immunotherapy History of CTCAE ≥ Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir) Active or chronic hepatitis B or C infection ° Previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion Known human immunodeficiency virus (HIV) infection Known leukemia or lymphoma Common variable immunodeficiency Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of ≥ 10 mg) Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients High likelihood of protocol non-compliance (in opinion of investigator) Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec Woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

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