Unresected Stage IIIb to IVM1c MelanomaNCT02147951
Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma
A study testing Talimogene Laherparepvec in people with Unresected Stage IIIb to IVM1c Melanoma, run by Amgen at 24 sites in United States.
Trial summary
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Unresected Stage IIIb to IVM1c Melanoma
- What is being tested?
- Talimogene Laherparepvec
- How many people
- Not given
- Where
- 24 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of melanoma
- Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
- Subject who is not eligible for or cannot access ongoing talimogene laherparepvec clinical trials
- Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
- for a subject not previously treated with talimogene laherparepvec:
- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion ≥ 10 mm in longest diameter, or
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- multiple injectable melanoma lesions that in aggregate have a longest diameter of ≥ 10 mm
- for a subject previously treated with talimogene laherparepvec:
- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion must be present (no minimal size criteria)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate organ function determined within 35 days prior to enrollment
- Serum LDH levels less than or equal to 1.5 ULN within 35 days prior to enrollment
- For a subject who previously received talimogene laherparepvec in another clinical trial, subject must have ended treatment for reason(s) other than disease progression or intolerability to talimogene laherparepvec
Who cannot join
- Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to enrollment.
- Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with less than or equal to 3 visceral metastases, no lesion > 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
- Bone metastases
- Primary ocular or mucosal melanoma
- History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
- Evidence of clinically significant immunosuppression
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- Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
- Currently receiving treatment with another investigational device or drug study besides talimogene laherparepvec, or less than 28 days since ending treatment with another investigational device or drug study(s)
- Other investigational procedures while participating in this protocol are excluded
- Known to have acute or chronic active hepatitis B or hepatitis C infection
- Known to have human immunodeficiency virus infection
- History of other malignancy within the past 3 years with the following exceptions:
- malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
- adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- adequately treated cervical carcinoma in situ without evidence of disease
- adequately treated breast ductal carcinoma in situ without evidence of disease
- prostatic intraepithelial neoplasia without evidence of prostate cancer
- adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- Subject has known sensitivity to any of the products or components to be administered during dosing
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen medical monitor, if consulted, would pose a risk to subject safety or interfere with the protocol evaluation, procedures or completion
- Female subject is pregnant or breast-feeding, or planning to become pregnant during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Research Site
Canton, Ohio, 44718
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75390
Research Site
Daytona Beach, Florida, 32117
Research Site
Duarte, California, 91010
Research Site
Franklin, Wisconsin, 53132
Research Site
Greenville, South Carolina, 29605
Research Site
Indianapolis, Indiana, 46260
Research Site
Jacksonville, Florida, 32207
Research Site
La Jolla, California, 92093-0698
Research Site
Little Rock, Arkansas, 72205
Research Site
Louisville, Kentucky, 40202
Research Site
Miami Beach, Florida, 33140
Research Site
Minneapolis, Minnesota, 55407
Research Site
Mobile, Alabama, 36604
Research Site
Mobile, Alabama, 36608
Research Site
Morristown, New Jersey, 07962
Research Site
New York, New York, 10016
Research Site
Omaha, Nebraska, 68130
Research Site
Omaha, Nebraska, 68198
Research Site
Portland, Oregon, 97213
Research Site
St Louis, Missouri, 63110-1093
Research Site
Wauwatosa, Wisconsin, 53226
Research Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects With Unresected, Stage lllB to IVM1c Melanoma
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma.
Read the detailed description
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma that may not meet the eligibility criteria to enroll in another ongoing Talimogene Laherparepvec study or do not have access to enroll in an ongoing Talimogene Laherparepvec study.
- Conditions
- Unresected Stage IIIb to IVM1c Melanoma
- Being tested
- Talimogene Laherparepvec
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talimogene LaherparepvecDrug
Up to 4ml of talimogene laherparepvec per cycle visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresected Stage IIIb to IVM1c MelanomaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147951
- Sponsor's protocol ID
- 20120166
- Status last verified
- Feb 2016
- First submitted
- 1 May 2014
- Last updated
- 1 Mar 2016
- Results posted
- No
Publications
Chesney J, Imbert-Fernandez Y, Telang S, Baum M, Ranjan S, Fraig M, Batty N. Potential clinical and immunotherapeutic utility of talimogene laherparepvec for patients with melanoma after disease progression on immune checkpoint inhibitors and BRAF inhibitors. Melanoma Res. 2018 Jun;28(3):250-255. doi: 10.1097/CMR.0000000000000444.
PubMed 29561296
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects With Unresected, Stage lllB to IVM1c Melanoma
- ClinicalTrials.gov ID
- NCT02147951
- Acronym / sponsor ID
- 20120166
- Conditions
- Unresected Stage IIIb to IVM1c Melanoma
- Keywords
- Melanoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma.
Detailed description
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma that may not meet the eligibility criteria to enroll in another ongoing Talimogene Laherparepvec study or do not have access to enroll in an ongoing Talimogene Laherparepvec study.
Study design
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed diagnosis of melanoma
- Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
- Subject who is not eligible for or cannot access ongoing talimogene laherparepvec clinical trials
- Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
- for a subject not previously treated with talimogene laherparepvec:
Key exclusion criteria (23 listed)
- Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to enrollment.
- Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with less than or equal to 3 visceral metastases, no lesion > 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
- Bone metastases
- Primary ocular or mucosal melanoma
- History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
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 LaherparepvecUp to 4ml of talimogene laherparepvec per cycle visit | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Derived from this study: PubMed 29561296Chesney J, Imbert-Fernandez Y, Telang S, Baum M, Ranjan S, Fraig M, Batty N. Potential clinical and immunotherapeutic utility of talimogene laherparepvec for patients with melanoma after disease progression on immune checkpoint inhibitors and BRAF inhibitors. Melanoma Res. 2018 Jun;28(3):250-255. doi: 10.1097/CMR.0000000000000444.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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.
MD study director
Amgen
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talimogene Laherparepvec in people with Unresected Stage IIIb to IVM1c Melanoma, run by Amgen at 24 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 13 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147951, which also lists 1 linked publication.
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 1 Mar 2016.