Unresected Stage IIIB to IVM1c MelanomaNCT02297529
Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma
A study testing Talimogene Laherparepvec in people with Unresected Stage IIIB to IVM1c Melanoma, run by Amgen at 3 sites in Switzerland.
Trial summary
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec. 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
- 3 sitesSwitzerland
- 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
- Provide informed consent prior to initiation of any protocol-specific activities/procedures.
- Male or female age ≥ 18 years at the time of informed consent.
- 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 6.Subject does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for stage IIIB to IVM1c melanoma
- 7. Candidate for intralesional therapy 8. Adequate organ function. 9. ECOG performance status of 0, 1, or 2.
Who cannot join
- Clinically active cerebral metastases.
- Greater than 3 visceral metastases.
- Bone metastases
- Primary ocular or mucosal melanoma.
- History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
- Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
Show all 13Show fewer
- Known to have acute or chronic active hepatitis B or C infection
- Known to have human immunodeficiency virus infection
- History of other malignancy within the past 3 years
- 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.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject has entered this protocol previously.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Research Site
Chur, 7000
Research Site
Lausanne, 1011
Research Site
Zurich, 8091
About this study
Official title: A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects in Europe With Unresected Stage IIIB to IVM1c Melanoma
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec.
Read the detailed description
This is a phase 3b, multicenter, open-label, single-arm, expanded access study of talimogene laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma in select European countries. Subjects with unresected stage lllB-IVM1c melanoma who are not eligible for or cannot access ongoing talimogene laherparepvec clinical trials and who meet the eligibility criteria outlined will be considered for participation in this protocol. Eligible subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumors have disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of therapy, intolerance of protocol treatment, or until talimogene laherparepvec receives marketing authorization approval in Europe for the treatment of melanoma, whichever occurs first. Subjects will be followed for safety approximately 30 (+7) days after the end of treatment. Thereafter, subjects who provide consent will be followed under an ongoing separate registry protocol for the long-term survival follow-up of subjects treated with talimogene laherparepvec in clinical trials. The registry protocol will also monitor for late and long-term adverse events thought to be potentially related to talimogene laherparepvec.
- Conditions
- Unresected Stage IIIB to IVM1c Melanoma
- Being tested
- Talimogene Laherparepvec
- Keywords
- unresected, Melanoma, expanded access, EU
- 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
Open label single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 106 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 108 PFU/mL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT02297529
- Sponsor's protocol ID
- 20120328
- Other IDs
- 2014-002834-30, 2014
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2014
- Last updated
- 31 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. 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 in Europe With Unresected Stage IIIB to IVM1c Melanoma
- ClinicalTrials.gov ID
- NCT02297529
- Acronym / sponsor ID
- 20120328
- Conditions
- Unresected Stage IIIB to IVM1c Melanoma
- Keywords
- unresected, Melanoma, expanded access, EU
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 21 Nov 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.
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec.
Detailed description
This is a phase 3b, multicenter, open-label, single-arm, expanded access study of talimogene laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma in select European countries. Subjects with unresected stage lllB-IVM1c melanoma who are not eligible for or cannot access ongoing talimogene laherparepvec clinical trials and who meet the eligibility criteria outlined will be considered for participation in this protocol. Eligible subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumors have disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of therapy, intolerance of protocol treatment, or until talimogene laherparepvec receives marketing authorization approval in Europe for the treatment of melanoma, whichever occurs first. Subjects will be followed for safety approximately 30 (+7) days after the end of treatment. Thereafter, subjects who provide consent will be followed under an ongoing separate registry protocol for the long-term survival follow-up of subjects treated with talimogene laherparepvec in clinical trials. The registry protocol will also monitor for late and long-term adverse events thought to be potentially related to talimogene laherparepvec.
Study design
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide informed consent prior to initiation of any protocol-specific activities/procedures.
- Male or female age ≥ 18 years at the time of informed consent.
- 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 6.Subject does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for stage IIIB to IVM1c melanoma
Key exclusion criteria (13 listed)
- Clinically active cerebral metastases.
- Greater than 3 visceral metastases.
- 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 LaherparepvecOpen label single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 106 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 108 PFU/mL. | 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 31 Oct 2019.
- 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
3 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 3 sites in Switzerland.
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 6 inclusion and 13 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 31 Oct 2019. 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 Switzerland. 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?
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 31 Oct 2019.