Status:
TERMINATED
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
Lead Sponsor:
Mayo Clinic
Conditions:
Stage III Cutaneous Melanoma AJCC v7
Stage IIIA Cutaneous Melanoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surge...
Detailed Description
PRIMARY OBJECTIVES OF PHASE I portion of the trial: To establish the safety and tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. PRI...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to curative local therapy
- Documented progression of disease after initiation of therapy with OR lack of response to therapy with a PD-1- or PD-L1-targeting monoclonal antibody (pembrolizumab, nivolumab, etc) after at least 18 weeks; NOTE: This treatment could have been at any time prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Minimum of 3 radiographically apparent lesions such that there is:
- Minimum of one lesion in areas that have not been previously irradiated that is considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria AND
- Minimum of two lesions in areas that have not been previously irradiated that are determined by interventional radiology to be of a size and in a location that a single probe could ablate at least 75% of the lesion; Note: Hepatic lesions measuring =\< 3 cm may be treated, as determined by interventional radiology; Note: Brain metastases are not acceptable as lesions defining measurable disease, nor are they candidate lesions for cryoablation
- Adequate venous access for apheresis as assessed by apheresis team; NOTE: If a central venous catheter is required for apheresis, the patient is not eligible
- Absolute neutrophil count (ANC) \>= 1000/mm\^3 obtained =\< 14 days prior to registration
- Absolute lymphocyte count \>= 500/mm\^3 obtained =\< 14 days prior to registration
- Platelet count \>= 100,000/mm\^3 obtained =\< 14 days prior to registration
- Hemoglobin \>= 10 g/dL obtained =\< 14 days prior to registration
- Total bilirubin =\< 1.5 x upper limit of normal (ULN), unless due to Gilbert?s disease obtained =\< 14 days prior to registration
- Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x ULN obtained =\< 14 days prior to registration
- Creatinine =\< 1.5 x ULN or calculated creatinine clearance \>= 60 mL/min for subject with creatinine ? 1.5 x institutional ULN obtained =\< 14 days prior to registration
- Negative serum pregnancy test for persons of childbearing potential =\< 7 days prior to registration
- Provide written informed consent
- Willing to return to the enrolling institution for follow-up (during active treatment and active monitoring phase of the study)
- Willing to provide tissue and blood samples for research purposes
- Willing to use adequate contraception while on the study and until 120 days after the last dose of study drug
Exclusion
- Any of the following:
- Pregnant persons
- Nursing persons
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Active tuberculosis or active, non-infectious pneumonitis
- Evidence of interstitial lung disease
- Active infection requiring the use of systemic antibiotics
- Symptomatic congestive heart failure (New York Heart Association classification III or IV cardiovascular disease, myocardial infarction =\< 6 months prior to registration, unstable angina pectoris or cardiac arrhythmia =\< 3 months prior to registration, or cardiac arrhythmia
- Currently receiving or have received any other investigational agent considered as a treatment for the primary neoplasm =\< 21 days prior to registration
- History of other primary malignancy requiring systemic treatment =\< 3 years prior to registration; patients must not be receiving chemotherapy or immunotherapy for another cancer; patients must not have another active malignancy requiring active treatment; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- Failure to recover from prior side effects of immune checkpoint inhibitor therapy to =\< grade 1; NOTE: Patients will not be excluded for adrenal insufficiency or hypothyroidism secondary to immunotherapy provided they are receiving hormonal replacement
- Major surgery =\< 4 weeks prior to registration
- Prior chemotherapy, targeted therapy, or radiation therapy =\< 2 weeks prior to registration or who has not recovered (i.e. to =\< grade 1 or baseline) from an adverse event due to the previously administered therapy
- History of hypersensitivity and anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid
- Active autoimmune disease such as Crohn?s disease, rheumatoid arthritis, Sjogrens? disease, systemic lupus erythematosus, or similar conditions requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease/syndrome difficult to control in the past; EXCEPTIONS (the following are allowed):
- Vitiligo or resolved childhood asthma/atopy
- Intermittent use of bronchodilators or local steroid injections
- Hypothyroidism stable on hormone replacement
- Diabetes stable with current management
- History of positive Coombs test but no evidence of hemolysis
- Psoriasis not requiring systemic treatment
- Conditions not expected to recur in the absence of an external trigger
- Secondary adrenal insufficiency from previous hypophysitis, currently on physiologic replacement steroid dosing only
- Coagulopathy, including the use of therapeutic anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed
- Corticosteroid use =\< 14 days prior to registration; NOTE: Patients must be off systemic corticosteroids for at least 2 weeks prior to registration; this includes oral or IV route of administration; patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent); patients receiving inhaled or intranasal or intra-articular steroids are not excluded
- Active central nervous system (CNS) metastasis; NOTE: Patients with prior brain metastases that are asymptomatic without corticosteroid use and stable or improved \>= 90 days after treatment with surgery or radiation are not excluded
- Receipt of a live vaccine =\< 30 days prior to registration
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03325101
Start Date
November 15 2017
End Date
June 14 2020
Last Update
June 12 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905