Health TrialsbyHealthPanel

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

ConditionMelanoma (Skin Cancer)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

A phase II double-blind placebo-controlled randomized trial. Patients with a clinical suspicion of a thick primary melanoma without clinical suspicion or evidence of lymph-node engagement will undergo a 3 mm punch biopsy to verify the diagnosis and ascertain eligibility. Patients will receive 1 cycle of pembrolizumab 400 mg or placebo and 4 weeks later undergo a wide local excision and sentinel lymph node biopsy according to the national guideline recommendations .

The primary objective is to evaluate the pathological response of one cycle of neoadjuvant pembrolizumab in patients with biopsy-proven stage IIb/c melanoma. Secondary objectives include efficacy and safety analysis, as well as biomarker discovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is ≥18 years.

Signed informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Histopathologically confirmed primary cutaneous melanoma stage IIb/c (Breslow >2.0 mm with ulceration OR Breslow >4.0mm without ulceration) with a minimum diameter of 5 mm not completely removed by the diagnostic biopsy

Disqualifiers

Life expectancy of less than 3 years.

Patients who are unable to undergo general anesthesia for any reason.

Clinical or radiographic evidence of nodal, satellite, in-transit or distant metastases

Risk for developing in-operable disease due to study procedures as judged by study investigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab

    Drug

    Immunotherapy

  • Placebo

    Drug

    Placebo

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PembrolizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pathological response rate

Pathological response rate in the primary tumor according to adapted guidelines of the International Neoadjuvant Consortium (14) The pathological response will be described: * Complete pathological response (pCR) - 0% viable tumor cells in the surgical specimen * Near complete pathological response (near pCR) - ≤10% viable tumor * Partial pathological response (pPR) - \>10%-≤50% viable tumor * No pathological response (pNR) - \>50% viable tumor The proportion of patients with a pCR, near pCR or pPR will determine the pathological response rate.

Time frame
48 month

Secondary outcomes

1

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)

The proportion of patients with adverse events (AE) as described in CTCAE version 5.0, from the initiation of study treatment until 100 days after the end of treatment: 1. Proportion of patients with an AE by CTCAE term and grade. 2. Proportion of patients with grade 3/4 AEs by AE term. 3. The duration of events reported in (a) 4. Proportion of patients with requirement to delay surgery due to an AE. 5. Proportion of patients with a requirement to permanently discontinue study treatment due to an AE. 6. The proportion of patients with a requirement for oral or parenteral steroid treatment for immunology-related adverse events. 7. The proportion of patients with post-operative complications (e.g. seroma formation, wound infection or lymphoedema) and duration of events.

Time frame
48 month
2

Feasibility of neoadjuvant therapy in stage II melanoma

1. Proportion of eligible patients who consent to the study. 2. Proportion of included patients who complete all treatment according to protocol.

Time frame
48 month
3

Sentinel lymph node positivity rate

1. The proportion of patients undergoing a sentinel node biopsy who have a positive result in the lymph node. 2. The number of sentinel nodes identified and the number harvested. 3. The proportion of patients with a positive sentinel node biopsy who undergo completion lymph node dissection.

Time frame
48 month
4

Local recurrence rate

The proportion of patients after surgery with histologically confirmed diagnosis of local disease recurrence, as detected by the patient, on physical examination or during imaging surveillance.

Time frame
48 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov
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