Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT06651151
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
NeoLIPA: a Single Center Phase II Open Label Study of Neoadjuvant LTX-315 in Combination with Pembrolizumab in Patients with Clinically Detectable and Resectable Stage III-IV Melanoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoLIPA
Brief Summary:
This clinical trial aims to evaluate the effectiveness of a new treatment approach for patients with stage III or IV melanoma that has spread to other parts of the body but can still be surgically removed. The study combines two treatments: LTX-315 and pembrolizumab.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment\'s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment\'s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.
Detailed Description:
This is a single arm, single center, open-label phase II study to assess the effect of neoadjuvant LTX-315 in combination with pembrolizumab in patients with clinically detectable and resectable stage III-IV melanoma.
Clinically detectable, fully resectable stage III or oligometastatic IV melanoma can be cured with surgery but has a very high risk of local or systemic recurrence. The risk of recurrence can be significantly reduced by adjuvant treatment with a PD-1 inhibitor. Due to the mode of action of PD-1 inhibitors (stimulating tumor reactive T cells), there is reason to believe that their effect is enhanced if given before definitive surgery and removal of tumor reactive T cells in the tumor microenvironment. Indeed, it was recently shown that the effect is greatly improved if three doses of pembrolizumab are administered prior to surgery (neoadjuvant), followed by 15 doses in the adjuvant setting, compared to giving 18 doses adjuvant.
Several studies have shown that pathologic complete response (pCR) after neoadjuvant treatment correlates with recurrence-free survival (RFS). The pCR rate neoadjuvant pembrolizumab is only modest (20%), and for 8% of the patients, disease progression in the neoadjuvant phase precludes the planned surgery.
LTX-315 is an oncolytic peptide generated from a host defense peptide and has both a direct killing activity and immunomodulatory properties. By inducing cell lysis and immunogenic cell death, LTX-315 can lead to increased T-cell infiltration, broadened repertoire of tumor antigens and increased diversity of T-cell clones, and thus has the potential to enhance the effect of pembrolizumab. Furthermore, the addition of LTX-315 to neoadjuvant pembrolizumab can lower risk of disease progression precluding surgery.
Clinically detectable, fully resectable stage III or oligometastatic IV melanoma can be cured with surgery but has a very high risk of local or systemic recurrence. The risk of recurrence can be significantly reduced by adjuvant treatment with a PD-1 inhibitor. Due to the mode of action of PD-1 inhibitors (stimulating tumor reactive T cells), there is reason to believe that their effect is enhanced if given before definitive surgery and removal of tumor reactive T cells in the tumor microenvironment. Indeed, it was recently shown that the effect is greatly improved if three doses of pembrolizumab are administered prior to surgery (neoadjuvant), followed by 15 doses in the adjuvant setting, compared to giving 18 doses adjuvant.
Several studies have shown that pathologic complete response (pCR) after neoadjuvant treatment correlates with recurrence-free survival (RFS). The pCR rate neoadjuvant pembrolizumab is only modest (20%), and for 8% of the patients, disease progression in the neoadjuvant phase precludes the planned surgery.
LTX-315 is an oncolytic peptide generated from a host defense peptide and has both a direct killing activity and immunomodulatory properties. By inducing cell lysis and immunogenic cell death, LTX-315 can lead to increased T-cell infiltration, broadened repertoire of tumor antigens and increased diversity of T-cell clones, and thus has the potential to enhance the effect of pembrolizumab. Furthermore, the addition of LTX-315 to neoadjuvant pembrolizumab can lower risk of disease progression precluding surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-508649-42-00 | CTIS | None | View |