Stage IV MelanomaPhase 1TACTI-melNCT02676869
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
A Phase 1 study testing IMP321 (eftilagimod alpha) and Pembrolizumab in people with Stage IV Melanoma and Stage III Melanoma, run by Immutep Australia Pty. Ltd. at 7 sites in Australia.
Trial summary
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma, Stage III Melanoma
- What is being tested?
- IMP321 (eftilagimod alpha) and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesAustralia
- Study dates
- Apr 2016to Dec 2019
- Phase
- Phase 1
- 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
Main Inclusion Criteria
- Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma
- Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to study start
- Female or male 18 years of age or above
- ECOG performance status 0-1
- Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria
Main Exclusion Criteria
- More than four prior lines of therapies for advanced or metastatic disease.
- Prior PD-1/PDL-1 targeted therapy
- Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
- Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
- History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
- Known cerebral or leptomeningeal metastases
- Serious intercurrent infection within 4 weeks prior to first dose of study treatment
- Active acute or chronic infection
- History or evidence of interstitial lung disease or active non-infectious pneumonitis
- Active auto-immune disease requiring immunosuppressive therapy
- HIV positivity, active hepatitis B or hepatitis C
- Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Flinders Medical Centre
Adelaide, South Australia, 5042
Ballarat Hospital
Ballarat, Victoria, 3353
Royal Brisbane Womens Hospital
Brisbane, Queensland, 4029
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Greenslopes Private Hospital
Brisbane, Queensland, 4120
Alfred Hospital
Melbourne, Victoria, 3181
Fiona Stanley Hospital
Perth, Western Australia, 6150
About this study
Official title: A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.
- Conditions
- Stage IV Melanoma, Stage III Melanoma
- Being tested
- IMP321 (eftilagimod alpha), Pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP321 (eftilagimod alpha)Drug
Also called Eftilagimod alpha
Part A: Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks
Part B: Single subcutaneous injections of 30 mg of IMP321 administered every 2 weeks
PembrolizumabDrug
Administered according to the approved label.
| Study group | Role | What they receive |
|---|---|---|
| IMP321 dose escalation | Experimental | IMP321 administered fortnightly in addition to SOC pembrolizumab. Receives: Drug: IMP321 (eftilagimod alpha); Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the recommended phase 2 dose
Measured: From the time of inform consent form signature until 30 days after end of treatment
To asses frequency of adverse events
Measured: From the time of inform consent form signature until 30 days after end of treatment
To asses severity of adverse events
Measured: From the time of inform consent form signature until 30 days after end of treatment
To asses duration of adverse events
Measured: From the time of inform consent form signature until 30 days after end of treatment
Secondary outcomes (4)
Best overall response rate (ORR) to irRC and RECIST 1.1
Measured: From the time of inform consent form signature until 30 days after end of treatment.
Time to next treatment (TTNT)
Measured: Up to 12 months
Progression-free survival
Measured: Up to 12 months
Overall survival (part B only)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV 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 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Study is an open label, dose finding study consisting of 2 parts. In part A, the dose is escalated following the protocol-defined safety observation period of the previous cohort. Patients will receive 9 cycles Pembrolizumab in combination with IMP321. In part B, the dose was defined based on the dose escalation. The treatment duration will be expanded to 19 cycles in the combined treatment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immutep Australia Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676869
- Sponsor's protocol ID
- IMP321-P012
- Acronym
- TACTI-mel
- Status last verified
- Dec 2019
- First submitted
- 2 Feb 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
- ClinicalTrials.gov ID
- NCT02676869
- Acronym / sponsor ID
- TACTI-mel / IMP321-P012
- Conditions
- Stage IV Melanoma, Stage III Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Immutep Australia Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Feb 2016 (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 purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study is an open label, dose finding study consisting of 2 parts. In part A, the dose is escalated following the protocol-defined safety observation period of the previous cohort. Patients will receive 9 cycles Pembrolizumab in combination with IMP321. In part B, the dose was defined based on the dose escalation. The treatment duration will be expanded to 19 cycles in the combined treatment.
| Arm | Type | Receives |
|---|---|---|
| IMP321 dose escalation | Experimental | Drug: IMP321 (eftilagimod alpha), Drug: PembrolizumabIMP321 administered fortnightly in addition to SOC pembrolizumab. |
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 |
|---|---|---|
| IMP321 (eftilagimod alpha)Also: Eftilagimod alphaPart A: Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks Part B: Single subcutaneous injections of 30 mg of IMP321 administered every 2 weeks | Drug | IMP321 dose escalation |
| PembrolizumabAdministered according to the approved label. | Drug | IMP321 dose escalation |
Primary outcome
To assess the recommended phase 2 dose
Time frame: From the time of inform consent form signature until 30 days after end of treatment
To asses frequency of adverse events
Time frame: From the time of inform consent form signature until 30 days after end of treatment
To asses severity of adverse events
Time frame: From the time of inform consent form signature until 30 days after end of treatment
To asses duration of adverse events
Time frame: From the time of inform consent form signature until 30 days after end of treatment
4 secondary outcomes
Best overall response rate (ORR) to irRC and RECIST 1.1
Time frame: From the time of inform consent form signature until 30 days after end of treatment.
Time to next treatment (TTNT)
Time frame: Up to 12 months
Progression-free survival
Time frame: Up to 12 months
Overall survival (part B only)
Time frame: Up to 12 months
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 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMP321 (eftilagimod alpha) and Pembrolizumab in people with Stage IV Melanoma and Stage III Melanoma, run by Immutep Australia Pty. Ltd. at 7 sites in Australia.
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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 assess the recommended phase 2 dose (time frame: From the time of inform consent form signature until 30 days after end of treatment). The study lists 4 primary outcomes in all. 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 18 Dec 2019.