Metastatic MelanomaPhase 3NCT00395070
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
A Phase 3 study testing Allovectin-7®, Dacarbazine (DTIC) and Temozolomide (TMZ) in people with Metastatic Melanoma, run by Vical at 88 sites in 14 countries.
Trial summary
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Allovectin-7®, Dacarbazine (DTIC) and Temozolomide (TMZ)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 88 sitesin 14 countries
- Study dates
- Oct 2006to Jul 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria (Potential study participants must meet the following criteria):
- Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
- At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
- Normal blood chemistries and blood cell counts
- At least 18 years old and able and willing to provide informed consent to participate
Exclusion Criteria (Potential study participants will not be eligible with the following):
- Previous chemotherapy treatment for melanoma
- Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
- If surgical removal of all lesions would be possible and could be curative
- Any melanoma tumors greater than 10cm x 10cm in size
- Known condition resulting in a suppressed immune system
- Female subjects who are pregnant
Trial locations and contacts
88 sites in 14 countries.
88 sites in 14 countries
United States27 sites
Location #87
Albuquerque, New Mexico, 87131
Location #1
Bakersfield, California, 93309
Location #35
Baltimore, Maryland, 21202
Location #12
Bethlehem, Pennsylvania, 18015
Location #7
Chicago, Illinois, 60068
Location #33
Chicago, Illinois, 60612
Location #41
Cincinnati, Ohio, 45219
Location #23
Cleveland, Ohio, 44106
Location #28
Dallas, Texas, 75246
Location #16
Denver, Colorado, 80045
Location #38
Hackensack, New Jersey, 07601
Location #117
Houston, Texas, 77030
Location #4
Kansas City, Missouri, 64111
Location #11
Lakeland, Florida, 33805
Location #9
Little Rock, Arkansas, 72205
Location #20
Louisville, Kentucky, 40202
Location #8
Montclair, New Jersey, 07042
Location #34
Portland, Oregon, 97239
Location #97
Providence, Rhode Island, 02903
Location #27
Salt Lake City, Utah, 84103
Location #26
Salt Lake City, Utah, 84112
Location #24
San Diego, California, 92093
Location #36
San Diego, California, 92161
Location #47
San Francisco, California, 94117
Location #32
Seattle, Washington, 98104
Location #19
St Louis, Missouri, 63110
Location #40
Tucson, Arizona, 85724
Germany11 sites
Location #90
Augsburg
Location #51
Berlin, 10117
Location #91
Dresden
Location #46
Hanover, 30449
Location #89
Jena
Location #50
Kiel, 24105
Location #48
Lübeck, 23538
Location #111
Ludwigshafen, 67063
Location #44
Münster, 48149
Location #52
Tübingen, 72076
Location #45
Würzburg, 97080
France9 sites
Location #110
Bordeaux, 33075
Location #112
Lyon, 69495
Location #113
Marseille, 13009
Location #114
Montpellier, 34295
Location #109
Nantes, 44093
Location #66
Paris
Location #74
Paris
Location #115
Toulouse, 31059
Location #116
Villejuif, 94800
Brazil8 sites
Location #99
Belo Horizonte, 30-380-490
Location #101
Curitiba, 81520-060
Location #104
Ijuí, 98700-000
Location #102
Itaquera, São Paulo, 08270-070
Location #100
Lajeado, 95900-000
Location #103
Porto Alegre, 90610-000
Location #105
Rio de Janeiro, 20230-0130
Location #106
São Paulo
Russia7 sites
Location #93
Barnaul, 656049
Location #61
Moscow, 115478
Location #58
Moscow, 143900
Location #62
Nizniy Novogrod, 603000
Location #57
Saint Petersburg, 197758
Location #94
Samara, 443066
Location #95
Stavropol
Italy5 sites
Location #82
Genoa
Location #78
Milan, 20141
Location #79
Naples
Location #80
Padova, 35128
Location #81
Siena
Turkey (Türkiye)4 sites
Location #122
Ankara, 06590
Location #124
Antalya, 07070
Location #121
Izmir, 35100
Location #123
Kocaeli, 41400
Canada3 sites
Location #37
Calgary, Alberta, T2N 4N2
Location # 75
Ottawa, Ontario, K1H 8L6
Location #88
Winnipeg, Manitoba, R3E 0V9
Israel3 sites
Location #86
Jerusalem, 91120
Location #84
Petah Tikva, 49100
Location #85
Tel HaShomer, 52621
Spain3 sites
Location #67
Barcelona, 08036
Location #54
Valencia, 46014
Location #68
Zaragoza, 50009
Netherlands2 sites
Location #59
Groningen, 9713 GZ
Location #60
Leiden, 2333
About this study
Official title: A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
Read the detailed description
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
- Conditions
- Metastatic Melanoma
- Being tested
- Allovectin-7®, Dacarbazine (DTIC), Temozolomide (TMZ)
- Keywords
- Melanoma, DTIC, TMZ, Stage 3, Stage 4, Metastatic, Metastatic Melanoma (Stage 3, Stage 4 Melanoma)
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allovectin-7®Biological
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Dacarbazine (DTIC)Drug
1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
Temozolomide (TMZ)Drug
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week. Receives: Biological: Allovectin-7® |
| Control Arm | Active comparator | DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days. Receives: Drug: Dacarbazine (DTIC); Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Measured: After all 375 subjects are enrolled
Secondary outcomes (2)
To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
Measured: After all 375 subjects are enrolled
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.
Measured: After all 375 subjects are enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Strause, PhD, Study director, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395070
- Sponsor's protocol ID
- LX01-315
- Status last verified
- Sep 2013
- First submitted
- 31 Oct 2006
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00395070
- Acronym / sponsor ID
- LX01-315
- Conditions
- Metastatic Melanoma
- Keywords
- Melanoma, DTIC, TMZ, Stage 3, Stage 4, Metastatic, Metastatic Melanoma (Stage 3, Stage 4 Melanoma)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Nov 2006 (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.
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
Detailed description
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Allovectin-7®Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week. |
| Control Arm | Active comparator | Drug: Dacarbazine (DTIC), Drug: Temozolomide (TMZ)DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Allovectin-7®Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week. | Biological | Treatment Arm |
| Dacarbazine (DTIC)1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR | Drug | Control Arm |
| Temozolomide (TMZ)150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days. | Drug | Control Arm |
Primary outcome
To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Time frame: After all 375 subjects are enrolled
2 secondary outcomes
To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
Time frame: After all 375 subjects are enrolled
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.
Time frame: After all 375 subjects are enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
Related trials for Metastatic Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
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.
Linda Strause, PhD study director
Vical
88 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allovectin-7®, Dacarbazine (DTIC) and Temozolomide (TMZ) in people with Metastatic Melanoma, run by Vical at 88 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Germany, France, Brazil, Russia and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. (time frame: After all 375 subjects are enrolled). 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 13 Sep 2013.