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Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study specific procedures. Participation in pharmacogenomics testing is optional |
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≥ 18 years of age |
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Histologically or cytologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed |
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Measurable disease on imaging based on RECIST 1.1 |
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Life expectancy of ≥ 3 months and ECOG performance status of 0 or 1 |
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Adequate organ and bone marrow reserve function, as indicated by the following laboratory values |
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Adequate hematological function, defined as absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 8 g/dL without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement) |
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Adequate liver function, defined as total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase ≤ 2.5 × ULN, and alanine aminotransferase ≤ 2.5 × ULN, albumin ≥ 3 g/dL, and alkaline phosphatase ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases |
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Adequate renal function defined as creatinine ≤ 1.5 × ULN OR measured or calculated creatinine clearance ≥ 40 mL/minute per institutional standard. Assessment methods should be recorded |
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Adequate coagulation, defined as international normalized ratio or prothrombin time ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN (unless patient is receiving anticoagulant therapy) |
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Patients with a history of prior malignancy are eligible if treatment was completed ≥ |
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years prior to the first dose of study treatment and the patient has no |
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evidence of disease |
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Patients must provide a sufficient and adequate formalin-fixed paraffin-embedded tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required |
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Female patients of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following |
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≥ 45 years of age and has not had menses for > 1 year |
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Amenorrheic for > 2 years without a hysterectomy and oophorectomy and follicle-stimulating hormone value in the postmenopausal range upon prestudy (screening) evaluation |
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Status is post-hysterectomy, -bilateral oophorectomy, or -tubal ligation |
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Female patients of childbearing potential must be willing to use highly effective |
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contraceptive measures starting with the Screening Visit through 90 days after |
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last dose of study treatment. Note: Abstinence is acceptable if this is the |
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established and preferred contraception method for the patient |
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Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the Screening Visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: Abstinence is acceptable if this is the established and preferred contraception method for the patient |
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Note: these specific criteria below are in addition to the general criteria above and |
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supersede the general criteria in some cases |
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Specific Melanoma Criteria |
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Inclusion |
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Histological confirmation of cutaneous melanoma |
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Progression on or within 24 weeks of stopping treatment with a PD-1/PD-L1 confirmed |
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per Society for Immunotherapy of Cancer (SITC) |
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Patients with BRAF V600-positive tumor(s) should also have received prior treatment |
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with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or have declined |
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targeted therapy |
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Note: Patients with BRAF V600-positive tumors with no clinically significant tumor-related |
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symptoms nor evidence of rapidly progressive disease are not required to be treated with a |
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BRAF inhibitor (alone or in combination with a MEK inhibitor) based on Investigator's |
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decision |
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Currently participating and receiving study therapy or has participated in a study of
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an investigational agent and received study therapy or used an investigation device
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within 3 weeks of first dose of current study treatment
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Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or
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major surgery outside of the acceptable washout period prior to first dose of study
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drug. A 1-week washout is permitted for palliative radiation to non-central nervous
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The following washout windows are acceptable from prior treatments (i.e., patients
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system (CNS) disease, with Sponsor approval
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with time periods less than the following should be excluded)
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Cytotoxic agent ≥ 3 weeks is acceptable (i.e., < 3 weeks should be excluded)
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Monoclonal antibodies ≥ 4 weeks is acceptable (i.e., < 4 weeks should be
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excluded)
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Proteasome inhibitors or corticosteroids ≥ 2 weeks is acceptable (i.e., < 2 weeks
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should be excluded)
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Small molecule/tyrosine kinase inhibitor within 14 days or less than 5
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circulating half-lives of investigational drug
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Having a previous SARS-CoV-2 vaccine > 7 days before administration. For vaccines
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requiring more than 1 dose, the full series should be completed prior to Cycle 1
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Day 1, when feasible, and when the delay in initiation of study treatment would
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not put the study patients at risk
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Patients who have received prior anti-CD137 therapy may be enrolled upon agreement
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with the Sponsor
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Persistent toxicity of NCI-CTCAE version 5.0 Grade > 1 severity that is related to
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prior therapy. Note: Sensory neuropathy or alopecia of Grade ≤ 2 are acceptable
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Expected to require any other form of systemic or localized antineoplastic therapy
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while on study (including maintenance therapy with another agent, radiation therapy
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History of (a) Severe (Grade ≥ 3) hypersensitivity reactions to fully human monoclonal
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and/or surgical resection)
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antibodies, (b) immune-related adverse event requiring treatment with systemic
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steroids for > 7 days (refer to Exclusion Criterion #7 for exceptions) excluding Grade
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or 2 rash; (c) interstitial lung disease or lung disease which may interfere with
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the assessment of pneumonitis; (d) uncontrolled asthma. (i.e., ≥ 3 features of partly
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controlled asthma); and (e) or pneumonitis that has required oral or IV
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corticosteroids)
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Receiving systemic corticosteroid therapy per Exclusion Criterion #2, or any other
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form of systemic immunosuppressive medication. Note: Corticosteroid use as a
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premedication for IV contrast allergies/reactions is allowed. Patients who are
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receiving daily corticosteroid replacement therapy are also an exception to this rule
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Daily prednisone at doses of ≤ 10 mg or equivalent hydrocortisone dose are examples of
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permitted replacement therapy. Use of inhaled or topical corticosteroids is permitted
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CNS tumor, metastasis(es), and/or carcinomatous meningitis identified either on the
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consent. Note: Patients with history of brain metastases that have been treated may
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baseline brain imaging obtained during the Screening Period or identified prior to
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participate provided they show evidence of stable supra-tentorial lesions at screening
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(defined as 2 brain images, both of which are obtained after treatment to the brain
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metastases and obtained ≥ 4 weeks apart). In addition, any neurologic symptoms that
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developed either as a result of the brain metastases or their treatment must have
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returned to baseline or resolved. Any steroids administered as part of this therapy
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must be completed ≥ 3 days prior to first dose of study medication
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years of the start of study treatment (i.e., with use of disease-modifying agents
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corticosteroids, or immunosuppressive drugs). Note: Patients with autoimmune
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Active or history of autoimmune disease that requires systemic treatment within 2
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conditions requiring hormone replacement therapy or topical treatment are eligible
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Active infection requiring systemic treatment
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Has had an allogeneic tissue/solid organ transplant except for corneal
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transplantation
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Active infection with HIV and CD4+ T-cell count <350/μL. Patients not on established
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defined by a detectable viral load. Testing is required for eligibility only if
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antiretroviral therapy for at least 4 weeks and having a detectable HIV viral load
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patient has a known or suspected history of infection
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Testing is not required for eligibility
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Clinically significant (i.e., active) cardiovascular disease: cerebral vascular
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Active infection with hepatitis B (surface antigen); or infection with hepatitis C
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accident/stroke or myocardial infarction within 6 months of enrollment, unstable
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angina, congestive heart failure (New York Heart Association class ≥ II), or serious
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uncontrolled cardiac arrhythmia requiring medication
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History or current evidence of any condition, therapy, any active infections, or
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laboratory abnormality that might confound the results of the study, interfere with
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the patient's participation for the full duration of the study, or is not in the best
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interest of the patient to participate, in the opinion of the treating Investigator
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Known psychiatric or substance abuse disorder that would interfere with cooperation
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with the requirements of the study
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Legally incapacitated or has limited legal capacity
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Pregnant or breastfeeding
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