MelanomaPhase 2NCT02819843
A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
A Phase 2 study testing TALIMOGENE LAHERPAREPVEC (TVEC) and Hypofractionated Radiotherapy in people with Melanoma and Merkel Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Merkel Cell Carcinoma, Other Solid Tumors
- What is being tested?
- TALIMOGENE LAHERPAREPVEC (TVEC) and Hypofractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jun 2016to 22 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ° 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
- Conditions
- Melanoma, Merkel Cell Carcinoma, Other Solid Tumors
- Being tested
- TALIMOGENE LAHERPAREPVEC (TVEC), Hypofractionated Radiotherapy
- Keywords
- T-VEC (Talimogene Laherparepvec), Radiotherapy, 16-224
- Medical subject headings
- Melanoma, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TALIMOGENE LAHERPAREPVEC (TVEC)Drug
Hypofractionated RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy | Experimental | 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. Receives: Drug: TALIMOGENE LAHERPAREPVEC (TVEC); Radiation: Hypofractionated Radiotherapy |
| Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy | Experimental | Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy. Receives: Drug: TALIMOGENE LAHERPAREPVEC (TVEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start21 Jun 2016
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Christopher Barker, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819843
- Sponsor's protocol ID
- 16-224
- Status last verified
- Apr 2024
- First submitted
- 28 Jun 2016
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02819843
- Acronym / sponsor ID
- 16-224
- Conditions
- Melanoma, Merkel Cell Carcinoma, Other Solid Tumors
- Keywords
- T-VEC (Talimogene Laherparepvec), Radiotherapy, 16-224
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy | Experimental | Drug: TALIMOGENE LAHERPAREPVEC (TVEC), Radiation: Hypofractionated RadiotherapyPatients 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. |
| Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy | Experimental | Drug: TALIMOGENE LAHERPAREPVEC (TVEC)Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TALIMOGENE LAHERPAREPVEC (TVEC) | Drug | Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy, Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy |
| Hypofractionated Radiotherapy | Radiation | Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy |
Primary outcome
Best Response
Time frame: 16 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Barker, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TALIMOGENE LAHERPAREPVEC (TVEC) and Hypofractionated Radiotherapy in people with Melanoma and Merkel Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.