This study has been transitioned to CTIS with ID 2023-509461-20-00 check the CTIS register for the current data. The primary objective is to investigate if IMO-2125 is capable of a) lowering the number of tumor positive SLN and b) inducing a loco-…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SLN tumor status 7 days after injection.
Secondary outcome
Loco-regional and systemic immune profile with emphasis on recruitment and/or
activation in the SLN of dendritic cell (DC), effector-T cell and Treg subsets,
and melanoma antigen-specific T cell responses in peripheral blood.
RFS and OS at 18 months, 24 months and 36 months after treatment.
Background summary
Currently, there is no widely used adjuvant treatment available to improve
survival after surgical excision of a primary melanoma. We previously described
loco-regional and systemic immune stimulation 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 the TLR-9 agonist CPG7909 (CpG-B ODN) intradermally at the excision
site of the primary tumor prior to the SLN biopsy (SNB). We now investigate the
clinical activity of a next-generation CpG ODN, IMO-2125, and its ability to
induce loco-regional and systemic immune stimulation in pT3-4cN0M0 melanoma
patients.
Study objective
This study has been transitioned to CTIS with ID 2023-509461-20-00 check the CTIS register for the current data.
The primary objective is to investigate if IMO-2125 is capable of a) lowering
the number of tumor positive SLN and b) inducing a loco-regional and systemic
immune response. The secondary objective is to investigate RFS and OS at 18
months, 24 months, 36 mnonths, 5 years en 10 jyears after treatment
Study design
A single center double-blind randomized and placebo-controlled Phase II
clinical trial.
Intervention
Seven days before SNB, patients will receive an intradermal injection, directly
adjacent to the excision site of the primary tumor, of 8mg IMO-2125 dissolved
in 1 mL saline (0.9% sodium chloride) (n=107) or 1mL plain saline alone
(placebo control n=107). 10 patients from each treatment arm will be enrolled
in an immune monitoring sub study.
Study burden and risks
The burden associated with participation includes one intradermal injection at
the VU university medical center. For the 20 patients in the immune monitoring
sub study, 50 ml heparinized blood will be drawn at 5 time-points that will be
planned together with standard treatment visits if possible but can result in 2
to 3 additional visits. The most common adverse events (AEs) seen with IMO-2125
are injection site reactions (ISR) and flu-like symptoms. In general, these
reactions occur early and resolve within 48 hrs with non-specific measures. We
do not expect to see any serious adverse events with IMO-2125 at this dose
level. Potential benefits of IMO-2125 treatment in this trial may include SLN
tumor clearance and a longer recurrence-free survival.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
1. Patients must be willing and able to sign the informed consent and comply
with the study protocol.
2. Must be >=18 years of age.
3. Histologically confirmed primary malignant melanoma cutis with a Breslow
tumor depth >2.0 mm
4. WHO Performance Status <=1.
5. Women of childbearing potential (WOCBP) and fertile men must agree to use
effective contraceptive methods from screening until at least 90 days after the
IMO-2125 administration.
Exclusion criteria
1. Known hypersensitivity to any oligodeoxynucleotide.
2. Active autoimmune disease requiring disease-modifying therapy at the time of
screening.
3. Pathologically confirmed loco-regional or distant metastasis.
4. Non-skin melanoma
5. Patients with another primary malignancy that has not been in remission for
at least 3 years with the exception of non-melanoma skin cancer, curatively
treated localized prostate cancer with non-detectable prostate-specific
antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial
lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
6. Active systemic infections requiring antibiotics.
7. Women who are pregnant or breast-feeding.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509461-20-00 |
| EudraCT | EUCTR2018-001992-19-NL |
| CCMO | NL66199.029.18 |