Malignant MelanomaPhase 2INTRIMNCT04126876
A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
A Phase 2 study testing Tilsotolimod and Saline (0.9% sodium chloride) in people with Malignant Melanoma, run by A.J.M. van den Eertwegh at 1 site in Netherlands.
Trial summary
Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Tilsotolimod and Saline (0.9% sodium chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2020to 1 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18 years or older
- Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)
- World Health Organization (WHO) Performance Status ≤1
- Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration
- Written informed consent
Who cannot join
- Known hypersensitivity to any oligodeoxynucleotide
- Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
- Pathologically confirmed loco-regional or distant metastasis
- Non-skin melanoma
- Patients with another primary malignancy (some exceptions)
- Active systemic infections requiring antibiotics
- Women who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
VU Medical Centere
Amsterdam, 1081 HV
About this study
Official title: A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is
- Conditions
- Malignant Melanoma
- Being tested
- Tilsotolimod, Saline (0.9% sodium chloride)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TilsotolimodDrug
Also called IMO-2125
Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
Saline (0.9% sodium chloride)Drug
Also called Placebo
Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
| Study group | Role | What they receive |
|---|---|---|
| Tilsotolimod (IMO-2125) | Experimental | Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). Receives: Drug: Tilsotolimod |
| Placebo | Placebo comparator | Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). Receives: Drug: Saline (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of tumor positive sentinal lymph node (SLN)
The rate of tumor positive sentinal lymph node (SLN)
Measured: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Secondary outcomes (3)
Immune response in the SLN and peripheral blood
Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood.
Measured: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Recurrence free survival (RFS)
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.
Measured: At 5 years and 10 years after sentinel node biopsy (SNB)
Overall survival
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.
Measured: At 5 years and 10 years after sentinel node biopsy (SNB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start22 Jan 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2031 (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 Malignant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Phase II Multicenter Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.J.M. van den Eertwegh
- Sponsor type
- University, hospital or other
- Collaborators
- Idera Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, A.J.M. van den Eertwegh, Amsterdam UMC, location VUmc
- Investigators
- Tanja de Gruijl, Principal investigator, Amsterdam UMC, location VUmcAlfons JM van den Eertwegh, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126876
- Sponsor's protocol ID
- 2018/418
- Acronym
- INTRIM
- Status last verified
- Apr 2021
- First submitted
- 10 Oct 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koster BD, van den Hout MFCM, Sluijter BJR, Molenkamp BG, Vuylsteke RJCLM, Baars A, van Leeuwen PAM, Scheper RJ, Petrousjka van den Tol M, van den Eertwegh AJM, de Gruijl TD. Local Adjuvant Treatment with Low-Dose CpG-B Offers Durable Protection against Disease Recurrence in Clinical Stage I-II Melanoma: Data from Two Randomized Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5679-5686. doi: 10.1158/1078-0432.CCR-17-0944.
PubMed 28972083
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
- ClinicalTrials.gov ID
- NCT04126876
- Acronym / sponsor ID
- INTRIM / 2018/418
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- A.J.M. van den EertweghUniversity, hospital or other
- Collaborators
- Idera Pharmaceuticals, Inc.
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 15 Oct 2019 (actual)
- 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.
Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Randomized Controlled Phase II Multicenter Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Tilsotolimod (IMO-2125) | Experimental | Drug: TilsotolimodIntradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). |
| Placebo | Placebo comparator | Drug: Saline (0.9% sodium chloride)Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)
- World Health Organization (WHO) Performance Status ≤1
- Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration
Key exclusion criteria (7 listed)
- Known hypersensitivity to any oligodeoxynucleotide
- Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
- Pathologically confirmed loco-regional or distant metastasis
- Non-skin melanoma
- Patients with another primary malignancy (some exceptions)
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 |
|---|---|---|
| TilsotolimodAlso: IMO-2125Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). | Drug | Tilsotolimod (IMO-2125) |
| Saline (0.9% sodium chloride)Also: PlaceboIntradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB). | Drug | Placebo |
Primary outcome
The rate of tumor positive sentinal lymph node (SLN)
Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
The rate of tumor positive sentinal lymph node (SLN)
3 secondary outcomes
Immune response in the SLN and peripheral blood
Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Recurrence free survival (RFS)
Time frame: At 5 years and 10 years after sentinel node biopsy (SNB)
Overall survival
Time frame: At 5 years and 10 years after sentinel node biopsy (SNB)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 28972083Koster BD, van den Hout MFCM, Sluijter BJR, Molenkamp BG, Vuylsteke RJCLM, Baars A, van Leeuwen PAM, Scheper RJ, Petrousjka van den Tol M, van den Eertwegh AJM, de Gruijl TD. Local Adjuvant Treatment with Low-Dose CpG-B Offers Durable Protection against Disease Recurrence in Clinical Stage I-II Melanoma: Data from Two Randomized Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5679-5686. doi: 10.1158/1078-0432.CCR-17-0944.
- Individual participant dataSharing planned: No
Related trials for Malignant Melanoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
Not yet recruitingPhase 1/2
Combination Immunotherapy Targeting Melanoma
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.
Tanja de Gruijl principal investigator
Amsterdam UMC, location VUmc
Alfons JM van den Eertwegh principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tilsotolimod and Saline (0.9% sodium chloride) in people with Malignant Melanoma, run by A.J.M. van den Eertwegh at 1 site in Netherlands.
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 7 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: looking for participants now, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica CL Notohardjo, MD (+3120 4444881, intrim@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of tumor positive sentinal lymph node (SLN) (time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126876, 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 15 Apr 2021.