Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT04513067
Eligibility Criteria:
Inclusion Criteria:
* Females or males age ≥ 18 years at the time of informed consent
* Patients with histologically or cytologically confirmed solid tumors with the potential to benefit from immunotherapy, such as triple negative breast cancer, colorectal cancer, liver cancer, non-small cell lung cancer, or renal cell carcinoma, who have progressed despite prior standard therapy or are intolerant of the standard therapy, or for whom no standard therapy exists. Patients with colorectal cancer should have received prior second-line therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* At least one measurable target lesion as outlined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at baseline
* Must have a site of disease amenable to biopsy and not chosen as target or non-target lesions for tumor response assessment (RECIST 1.1)
* Expected life expectancy of ≥ 12 weeks
* Adequate bone marrow function at screening:
* Hemoglobin \> 8.5 g/dl
* Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
* Platelet count ≥ 75 x 10\^9/L
* PT-INR \< 1.5 or APTT \< 1.5 x upper limit of normal
* Adequate liver function at screening:
* Total bilirubin ≤ 1.5 x upper limit of normal
* Serum AST and ALT ≤ 2.5 x upper limit of normal
* Adequate renal function at screening:
* Serum creatinine \<1.5 x upper limit of normal and creatinine clearance (using Cockcroft Gault formula) \> 50 mL/min
* Willing to receive bovine products
* Able to provide written informed consent
* Willing and able to comply with all aspects of the study
Exclusion Criteria:
* Subjects who have received any anti-cancer treatment or investigational agent within 21 days prior to the first dose of the trial treatment
* Any surgery or radiotherapy within 28 days prior to the first dose of the trial treatment
* Any toxic effects (except \<= Grade 2: hair loss, vomiting, nausea, sensory neuropathy, endocrinopathies under stable dose of replacement therapy and abnormalities of thyroid hormones) of the prior therapy which have not been resolved to Grade 1 or less (based on CTCAE v.5.0)
* Subjects who have been discontinued from treatment due to drug-related toxicities with prior therapy directed against the same target as pembrolizumab
* Subjects who have received any anti-CTLA-4 monoclonal antibodies in the past
* Symptomatic central nervous system (CNS) metastases
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated \> 3 years prior to study entry
* Any history of or current active cardiac disease/dysfunction including, but not limited to, any of the following:
1. Cardiomyopathy
2. Congestive heart failure \> NYHA class 2
3. Coronary artery disease e.g. myocardial infarction, angina pectoris and symptomatic pericarditis
4. Cardiac arrhythmias, e.g. supraventricular, ventricular or bradyarrhythmias
5. 12-lead electrocardiogram parameters at screening: QTc interval \> 450 msec, PR interval \> 220 msec, or QRS duration \> 109 msec
6. Echocardiogram left ventricular ejection fraction \< 60% as determined by echocardiography at screening
7. Abnormal MRI cardiac perfusion scan at screening
8. Abnormal cardiac symptoms at screening: bradycardia (heart rate \< 50 beat/min at rest), tachycardia (heart rate \> 90 beat/min at rest)
9. Uncontrolled hypertension or a supine systolic blood pressure \> 160 or \< 90 mmHg at screening
* Known connective tissue disease
* Active or known autoimmune disease. (Note: Patient with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll)
* Active or known hemolytic disorder
* Subjects receiving chronic treatment with systemic (oral/intravenous) steroid therapy (\> 10mg/day prednisone or equivalent) within 7 days prior to the first dose of trial treatment.
* Subjects receiving chronic treatment with systemic (oral/intravenous) immunosuppressive medication that may interfere with the action of the trial treatment
* Known to be serologically positive for human immunodeficiency viruses (HIV)
* Patients with active Hepatitis B infection (HBsAg positive) and not adequately controlled by antiviral with HBV DNA \>1000 IU/mL shall be excluded
* Patients with a positive test for hepatitis C ribonucleic acid
* Co-existing active infection requiring parenteral antibiotics or serious concurrent illness deemed clinically significant within 4 weeks prior to the first dosing of the study drug.
* Patients with a seizure disorder requiring medication (such as steroids or anti-epileptics)
* Patients undergoing renal dialysis
* Patients with clinically significant proteinuria at screening (clinically significant proteinuria is defined as urinary protein \>=3.5g/24 hours)
* Patients who have received organ transplantation
* Patients who have received blood transfusion within 4 weeks prior to trial treatment
* Known hypersensitivity to any blood product and therapeutic antibody
* Known allergy to bovine products
* Patients who have received bovine hemoglobin-based oxygen carrier (HBOC) or other HBOC in the past
* Female who is pregnant or breast-feeding at screening or baseline
* Female of childbearing potential who is not willing to use 2 methods (1 primary and 1 secondary method) of birth control throughout the trial treatment period and for 6 months after discontinuation of the treatment
* Male subject with female partner of childbearing potential is not willing to use a male barrier method of contraception (i.e. male condom with spermicide) in addition to a second acceptable contraception method throughout the treatment period and for 6 months after discontinuation of the treatment
* Any condition that is unstable or could jeopardize the safety of the subjects and their compliance in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04513067
Study Brief:
Protocol Section:
NCT04513067