Immunotherapeutic treatment with Pembrolizumab (antibody) in melanoma patients at high risk of recurrence after complete surgical resectio

• Conditions: Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases); MedDRA version: 18.0Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004944-37-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

- At least 18 years of age.
- Complete resection of Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases).
- Melanoma with unknown origin of the primary is eligible
- Mandatory to ship tumor sample for evaluation of PD-L1 expression.
- The treatment should start no later than 13 weeks after surgery and only after complete wound healing from the surgery.
- Disease status for the post-surgery baseline assessment must be documented by full Chest/Abdomen/Pelvis CT and/or MRI with Neck CT and/or MRI (for Head and Neck primaries) and complete clinical examination after the informed consent and prior to enrollment.
- Disease-free (no loco-regional relapse or distant metastasis); no clinical evidence for brain metastases.
- BRAF mutation status
- ECOG performance status of 0 or 1.
- Patient demonstrates adequate organ function as defined in the protocol
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment.
- Patients of childbearing / reproductive potential should use adequate birth control methods.
- Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last dose of study drug .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 738
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 162

Exclusion Criteria

- Mucosal or ocular melanoma.
- Prior therapy for melanoma except surgery for primary melanoma lesions.
- history of pneumonitis requiring treatment with steroids, no history of interstitial lung disease.
- history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years.
- active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- active infection requiring therapy.
- diagnosis of immunodeficiency, no systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C.
- treatment with live vaccines within 30 days prior to the first dose of study medication are not eligible.
- prior treatment with any anti-CTLA4 monoclonal antibody or anti-PD-1, or PD-L1 or PD-L2 agent.
- Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of treatment
- patient is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
- female patients who are Breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified