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RECRUITINGEarly Phase 1INTERVENTIONAL

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

Who May Be Eligible (Plain English)

\*This list is representative of study inclusion/exclusion criteria. Each substudy may include variations on these criteria. Who May Qualify: 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 \[solid tumors\] indicated in the relevant substudy(ies). 4. Ability and willingness to provide written willing to sign a consent form. 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5. At least one lesion (primary tumor, recurrent 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. 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 willing to sign a consent form Form (ICF) and during 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
\*This list is representative of study inclusion/exclusion criteria. Each substudy may include variations on these criteria. 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 \[solid tumors\] indicated in the relevant substudy(ies). 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. At least one lesion (primary tumor, recurrent 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. 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 Informed Consent Form (ICF) and during 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 and during 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 β-subunit human chorionic gonadotropin (β-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.

Treatments Being Tested

BIOLOGICAL

Rilvegostomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Volrustomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Sabestomig

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Pembrolizumab

Intratumoral microdose injection by the CIVO device.

Locations (12)

UC Davis
Sacramento, California, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
UC Health
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Charleston, South Carolina, United States
UT Health
Houston, Texas, United States
University of Washington
Seattle, Washington, United States