| Eligibility |
Inclusion Criteria:
1. Ability and willingness to comply with the study's visit and assessment schedule.
2. Male or female = 18 years of age at Visit 1 (Screening).
3. Pathologic diagnosis of HNSCC, STS (see restrictions in Note below), or TNBC (see
restrictions in Note below; TNBC defined as estrogen receptor negative [<1% positive
tumor cells], progesterone receptor negative [<1% positive tumor cells], and human
epidermal growth factor receptor 2 negative [0 to 1+]) with a tumor planned for
surgical resection.
Note: For STS, only the following subtypes are eligible: undifferentiated pleomorphic
sarcoma, alveolar soft part sarcoma, synovial sarcoma, cutaneous angiosarcoma, or
myxofibrosarcoma.
Note: For TNBC, if prior neoadjuvant therapy, evidence of progressive disease, at the
discretion of the investigator.
4. Ability and willingness to provide written informed consent. Voluntary written consent
must be given before performance of any study related procedure not part of standard
medical care, with the understanding that consent may be withdrawn by the patient at
any time without prejudice to future medical care.
5. As assessed or confirmed by the surgeon, at least one lesion (primary tumor, recurrent
tumor, metastatic tumor, or metastatic lymph node) that is surface accessible for CIVO
injection that contains viable minimum tumor tissue volume and characteristics (e.g.,
based on clinical evaluation, available pre-operative imaging, pre-injection
ultrasound imaging, or pathology reports indicating lesion with appropriate viable
tumor volume without excessive cysts or necrosis) and for which there is a planned
surgical intervention. The patient's presentation, surgical and pathology plan may
determine whether a lesion is eligible with respect to a given CIVO MID needle
configuration.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
7. Female patients who:
- Are postmenopausal for at least one year before the screening visit, OR
- Are surgically sterile, OR
- Are of childbearing potential who agree to practice a highly effective method of
contraception from the time of signing the ICF up to 3 months following the end
of study participation OR agree to completely abstain from heterosexual
intercourse.
- Agree to refrain from donating ova during study participation.
Male patients, even if surgically sterile (i.e., status post-vasectomy), who:
- Agree to practice effective barrier contraception from the time of signing the ICF up
to 3 months following the end of study participation OR agree to completely abstain
from heterosexual intercourse.
- Agree to refrain from donating sperm during study participation.
Exclusion Criteria:
1. Tumors near or involving critical structures for which, in the opinion of the treating
clinician, injection would pose undue risk to the patient.
2. Female patients who are:
- Both lactating and breastfeeding, OR
- Have a positive ß-subunit human chorionic gonadotropin (ß-hCG) pregnancy test at
screening verified by the Investigator.
3. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric
illness, or circumstance that, in the opinion of the Investigator, could interfere
with adherence to the study's procedures or requirements, or otherwise compromise the
study's objectives.
4. HNSCC known to be of cutaneous origin.
5. Patients with uncontrolled autoimmune diseases (see Appendix 1 for examples) requiring
systemic treatment
6. Patients with known HIV/AIDS.
7. Patients with known uncontrolled active hepatitis B (defined as hepatitis B surface
antigen [HBsAg] positive or detectable hepatitis B virus [HBV] DNA) or hepatitis C
(defined as anti-hepatitis C virus antibody [anti-HCV Ab] positive and detectable
hepatitis C virus [HCV] RNA) infection.
Note: Hepatitis B and C screening tests are not required unless:
- Patient has a known history of hepatitis B/C infection
- Mandated by local health authority
8. Use of any of the following = 3 weeks prior to CIVO injection:
1. Systemic anti-cancer therapy (e.g., cytotoxic chemotherapy, targeted agents, or
checkpoint inhibitor immunotherapy, etc.),
2. Immunosuppressive drugs (e.g., calcineurin inhibitors)
3. Biological response modifiers for autoimmune disease
4. Systemic glucocorticoids: oral or parenteral corticosteroids at a dose = 20
mg/day prednisone, or equivalent Note: physiologic replacement dosing of steroids
(= 3 mg/m2/d prednisone or equivalent), low-dose corticosteroids for dye
allergies prior to staging scans or use in anti-emetic prophylaxis for patients
undergoing chemotherapy, or topical steroids, are allowed
5. Hematopoietic growth factors
6. Chemotherapy
7. Local radiotherapy of the target lesion planned for CIVO injection and surgical
resection
9. Patients who have received a live or live attenuated vaccine within 4 weeks of the
baseline/screening visit.
10. Patients who have had allogenic tissue/solid organ transplant
11. Patients with an active infection requiring systemic therapy.
12. Patients for whom participation on this study results in a delay of planned surgical
intervention.
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