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Trial · Interventional

RecruitingPhase 2Registry data

NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma

Short name NeoLIPA

NCTNCT06651151 (opens ClinicalTrials.gov in a new tab)Other id2023_16Other id2023-508649-42-00Other id2023

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
27 participants (estimated)
Sponsor
Oslo University Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Norway

Start
1 Nov 2024 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2031 (estimated)
First posted
21 Oct 2024
Last update posted
26 Oct 2024
Conditions
Melanoma Stage IIIB-IV

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242026202820302032
  1. Ph 2

    NeoLIPA

    NCT06651151

    est. 1 Nov 2024 to est. May 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LTX-315 + pembrolizumabDrug

Arms1

  • Experimental

    Experimental

    LTX-315 will be injected directly into the selected tumor once weekly for a maximum of 5 dosing days. Pembrolizumab will be given as 200 mg IV infusion over 30 minutes every 3 weeks for a maximum of 18 doses of which three doses will be given prior to the planned surgery.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Complete Pathologic Response Rate

    Time frame · 12 weeks after start of treatment

    Registry description

    Rate of pathologic complete response (pCR), defined as complete absence of viable tumor in the treated tumor bed.

Secondary outcomes(7)
  1. Safety Evaluation

    Time frame · Continously from first dose of treatment to 90 days after last study drug administration

    Registry description

    Frequency, nature and severity of AE according to NCI CTCAE v 5.0: * All AEs * LTX-315 treatment-related AEs * LTX-315 and/or pembrolizumab treatment-related AEs

  2. Objective response rate (ORR)

    Time frame · After 12 weeks of treatment

    Registry description

    Rate of CR or PR as per RECIST version 1.1 prior to surgery

  3. Pathologic Response Rate

    Time frame · After 12 weeks of treatment

    Registry description

    Rate of partial (less than 50% of the treated tumor bed is occupied by viable tumor cell) or complete pathologic response. Rate of Major Pathologic Response (MPR) defined as complete or near-complete (less than 10% of viable tumor in the treated tumor bed) pathologic response

  4. Event free survival (EFS)

    Time frame · From first dose of treatment to two years

    Registry description

    Defined as time from start of treatment to progression of disease that precludes surgery, recurrence (local or distant) or death

  5. Recurrence free survival (RFS)

    Time frame · Two years after surgery

    Registry description

    Defined as the time from surgery to recurrence or death.

  6. Overall Survival (OS)

    Time frame · Three years after surgery

    Registry description

    Overall Survival

  7. Quality of Life (QoL)

    Time frame · From first dose to end of treatment at approximately 1.5 years

    Registry description

    Patient reported outcomes (PRO)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participant must be 18 years of age inclusive, at the time of signing the informed consent. * Histologically confirmed, clinically detectable stage III-IV(M1a) melanoma, judged fully resectable and eligible for neoadjuvant treatment by consensus at a multidisciplinary tumor board. Patients with melanoma of cutaneous (including acral) or mucosal (including conjunctival) origin are eligible. Clinically detectable is defined as being apparent and measurable by radiological assessments or physical examination. * Measurable disease as per RECIST version 1.1 criteria. * Judged medically fit to undergo the planned surgery by the surgical team. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have at least one superficial cutaneous, subcutaneous or lymph node lesion available for injection with a maximum mean longest perpendicular diameter (LPD) of 3.0 cm. * Willing to undergo an additional tumor biopsy and submit biopsy and surgical specimens * Adequate organ function as defined below: 1. Hemoglobin \> 9 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L 3. Platelet count ≥ 80 x 109/L e. Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) f. AST and ALT ≤2.5 x ULN g. Albumin \>30 g/L h. Serum creatinine ≤1.5 X ULN OR measured creatinine clearance (CL) \>30 mL/min * Female participants are willing to use contraceptive measures as prescribed by the protocol from study visit 1 to 120 days after the last dose of study intervention. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of first study intervention. * Capable of giving signed informed consent as described in section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Uveal melanoma. Patients with acral, mucosal or conjunctival melanoma are eligible. * History of brain, bone, liver metastases or leptomeningeal metastases. * Patients with stage IV disease having ≥4 metastatic sites. * A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. * Active autoimmune disease requiring systemic immunomodulatory treatment. Replacement therapy (e.g. physiologic doses of corticosteroids, insulin, thyroxine) is allowed. * Patient has history of, or any evidence of interstitial lung disease (ILD) or non-infectious pneumonitis that required systemic corticosteroids. * Prior malignancy that require concurrent therapy. * Allergy/hypersensitivity to prophylactic treatments; known hypersensitivity to pembrolizumab or LTX-315 or any of their excipients * Previous treatment with anti-cancer immunotherapy, including (but not limited to) CTLA-4 or PD-1 inhibitors. Prior non-immunotherapy adjuvant treatment (e.g. dabrafenib + trametinib or radiotherapy), and regional therapy such as ECT or ILP is permitted (≥ 12 weeks prior to enrollment). * Currently taking immunosuppressive agents or use of systemic corticosteroids (≥10 mg of prednisolone or equivalent) or other systemic immunosuppressive drugs within 28 days prior to study drug administration. Topical and inhaled corticosteroids are allowed. * Have received a live vaccine within 30 days prior to first dose of treatment * Have received an investigational drug within 4 weeks to day 1, or are scheduled to receive one during the treatment period. * Pregnant or breastfeeding. * Any reason why, in the opinion of the investigator, the patient should not participate.

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