Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years
• Subjects susected or diagnosed with Stage IV/ metastatic or patients receiving neoadjuvant CPIfor resectable early stage of solid malignancies:
  • Lung: Non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC);
  • Kidney: Clear Cell Renal Cell Carcinoma (ccRCC);
  • Bladder: Urothelial Carcinoma (UC);
  • Skin: Cutaneous Melanoma, excluding Uveal Melanoma;
  • Prostate Cancer: metastasis castration resistance;
  • Breast Cancer including triple negative breast cancer (TNBC);
  • Liver and Esophageal cancers;
  • All tumor types with high TMB and are microsatellite instability high (MSI-H);
  • Cervical cancer.

Locally advanced/Metastatic patients:

• Measurable disease as defined in Section 11.0.NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.
• Subjects must be eligible based on investigator discretion to receive CPI monotherapy or combination therapy (e.g. combining two CPIs such as anti-PD-1 plus anti-CTLA4) or CPI theapy in combination with chemotherapy or genometargeted therapy:
  • Subjects must be treatment-naïve at the time of biopsy if they are newly diagnosed;
  • Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2-4 weeks prior to biopsy as per the agents used.
  • Subjects with a confirmed diagnosis who have previously undergone a standard of care (SOC) biopsy must be willing to undergo a separate biopsy procedure solely for the purposes of this study. 
• ECOG Performance Status (PS) 0, 1 or 2 (Appenx I).
• The following laboratory values obtained ≤ 14 days prior to registration: (Verify this matches Section 4.0):
  • Hemoglobin ≥ 9.0 g/dL;
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
  • Platelet count ≥100,000/mm^3;
  • Total bilirubin ≤ 1.5 x ULN; 
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement);
  • PT/INR/aPTT ≤1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy;
  • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:
    • Creatinine clearance for males = (140 − age)(weight in kg) (72)(serum creatinine in mg⁄dL);
    • Creatinine clearance for females = (140 − age)(weight in kg)(0.85) (72)(serum creatinine in mg⁄dL).
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
• Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.
• Subjects must be clinically able, at investigator discretion, to undergo extra core needle biopsy passes during their biopsy from a tumor site that yields a biopsy of at least 10 mm in length, and ideally longer.
• Subjects with a secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for primary diagnosis. 3.19b Provide written informed consent.
• Willingness to provide optional blood specimens for correlative research (see Section 14.0).
• Willingness to provide mandatory tissue specimens (see Section 17.0).
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria:

• Pregnant women because this study involves a greater than minimal risk procedure (study biopsy).
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy.
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy:
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection; or
  • Psychiatric illness/social situations that would limit compliance with study requirements.
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment:
  • EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/16/23. Questions regarding updates should be directed to the study team contact.