RECIST definition

RECIST means an acronym that stands for "Response Evaluation Criteria in Solid Tumours" and is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Response as defined by RECIST criteria have been published, for example, at Journal of the National Cancer Institute, Vol. 92, No. 3, Feb. 2, 2000 and RECIST criteria can include other similar published definitions and rule sets. One skilled in the art would understand definitions that go with RECIST criteria, as used herein, such as "PR," "CR," "SD" and "PD."
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Examples of RECIST in a sentence

  • RECIST 1.1 (▇▇▇▇▇▇▇▇▇▇ 2009) will be adapted to account for the unique tumor response characteristics seen with treatment of pembrolizumab.

  • Progressive disease should be defined radiologically as per RECIST version 1.1 and be based on CT or MR scans and aided if necessary, after discussion at the National CAR T Clinical Panel, with the use of Lugano lymphoma response criteria.

  • Four of the 31 (13%) patients demonstrated a sustained objective regression of their metastatic melanoma assessed by standard RECIST (Response Evaluation Criteria In Solid Tumors) criteria.

  • Standard RECIST may not provide an accurate response assessment of immunotherapeutic agents such as pembrolizumab.

  • Therefore, RECIST 1.1 will be used with the following adaptations: • Patients with progressive radiographic metastatic disease who are clinically asymptomatic and without other significant reason to discontinue therapy (i.e., toxicity, physician's judgement or patient's decision to stop therapy) may continue to receive study therapy per protocol until the next scheduled tumor assessment (Table 3) to confirm progression.

  • Study Objectives ● To assess efficacy of best overall response rate (B▇▇▇) by independent central review based on RECIST v1.1 over 24 weeks (end of Core study) of intratumoral pIL-12-EP in combination with pembrolizumab (IV) (collectively ‘the combined treatment’) in patients with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with other approved checkpoint inhibitor.

  • Note: When disease progression has been confirmed by imaging per RECIST criteria, biopsy specimens are to be collected from consenting patients preferably from a new accessible metastatic lesion or one that increased in size when compared to the previous imaging scan result from consenting patients.

  • Clinical Study Start-Up Fee XXXXXXXXX Certificate – Clinical Biochemistry XXXXXXXXX Certificate – Hematology XXXXXXXXX Screen Failures XXXXXXXXX * CT Scanwith contrast: chest, abdomen, pelvis combined XXXXXXXXX Radionuclide bone scan (Whole body) XXXXXXXXX RECIST 1.1 XXXXXXXXX Survival and subsequent therapy follow-up: after study treatment termination every 3 months for up to 60 months from date of randomization or until death, loss to follow-up or study closure.

  • RECIST outcomes will be calculated by AZ programming or designee.

  • Patients must have objective and measurable melanoma by RECIST 1.1 after disease progression on a prior anti-PD-1 or anti-PD-L1 therapy.