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. 2022 May 30;12(5):e060342. doi: 10.1136/bmjopen-2021-060342

Table 2.

Eligibility criteria

Category Inclusion criteria Exclusion criteria
Demographics
  • Male or female patients 18 years of age or older

Female patients that are pregnant
Clinical presentation
  • Patients must have measurable disease according to RECIST criteria and at least one lesion that can be accurately measured in at least one dimension as >10 mm

  • Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:

    melanoma, non-small cell lung cancer, colorectal cancer

  • ECOG Performance status 0, 1 or 2

Patients who have initiated immunotherapy
Medical history
  • Patients must be clinically eligible and plan to initiate therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4 or anti-PD-L1:

    • Pembrolizumab (Keytruda)

    • Nivolumab (Opdivo)

    • Ipilimumab (Yervoy)

    • Durvalumab (Imfinzi)

    • Cemiplimab (Libtayo)

    • Atezolizumab (Tecentriq)

    • Avelumab (Bavencio)

  • Patients must be able to follow the study visit schedule and be willing to provide up to 20 mL of peripheral blood samples at the indicated time points

Patients with a history of bone marrow or organ transplant, a medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder, or a serious medical condition that may adversely affect the ability to participate in the study
Provider-based criteria
  • Selected by their HCP to receive ctDNA assay according to the current evidence-informed schedule as part of their routine of practice

ctDNA, circulating tumour DNA; CTLA-4, cytotoxic T‐lymphocyte associated antigen-4; HCP, healthcare provider; PD-1, programmed cell death-1; PD-L1, programmed cell death ligand 1.