10061: A Phase 1 Study of Pembrolizumab (MK-3475) in Combination with Recombinant Interleukin-12 in Patients with Solid Tumors (CTMS# 21-0066)
Cancer Type
Solid Tumor
ClinicalTrials.gov Identifier
ClinicalTrials.gov registration not required
Principal Investigator
John Sarantopoulos MD
For more information about this study
View DetailsAbout This Study
This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Recombinant interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than giving pembrolizumab alone in treating patients with solid tumors.
What is the criteria to participate?
Note: This is only a partial list of eligibility criteria.
Inclusion Criteria:
Other Inclusion Criteria:
willingness to undergo tumor biopsies at three timepoints: (1) pre-treatment; (2) after one week of rhIL12; and (3) after 2 cycles of pembrolizumab (MK-3475)-IL12 (i.e., approximately 7 weeks from the first dose of rhIL-12). o Cytopathologist should be present to ensure adequacy of tumor biopsy sample. o At least 4 16G core biopsies are to be obtained and triaged as delineated in Section 9. o Adequate (capable of providing at least 20 unstained slides); and o Recent (within 8 weeks of study entry); and o Patient has not had any intervening therapy Patients must have measurable disease based on RECIST 1.1. Ability to understand and the willingness to sign a written informed consent document. Patients who are Human Immunodeficiency Virus (HIV) positive may participate IF they meet the following eligibility requirements: |
Exclusion Criteria:
Other Exclusion Criteria:
Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of trial treatment, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients who are currently participating in or have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of trial treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier. Non-clinically significant adverse events may be considered as an exception after discussion with and approval by the principal investigator.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Patients with known active and untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab (MK-3475) and/or rhIL-12 or other agents used in study.
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Patients on any systemic corticosteroid therapy within one week before the planned date for first dose on study would not be eligible. Exception: patients on physiologic replacement doses of corticosteroids are permitted.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Pregnant women are excluded from this study because pembrolizumab (MK-3475) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab (MK-3475), breastfeeding should be discontinued if the mother is treated with pembrolizumab (MK-3475). These potential risks may also apply to other agents used in this study.
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days prior to the first dose of trial treatment.