ESMO gastrointestinal oncology · 2026
ENVELOPE: enfortumab vedotin in patients with advanced small bowel adenocarcinoma refractory or intolerant to platinum-based therapy-phase II investigator-initiated trial (NCCH2412/MK015).
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Fujii H, Hirano H, Kudo T, Tsuchihashi K, Shoji H, Okita N, Hirose T, Takashima A, Yokoyama M, Kawasaki M, Shuda Y, Naito M, Ichikawa K, Sekine K, Sato J, Yamamoto N, Kato K
Аннотация
BACKGROUND: Small bowel adenocarcinoma (SBA) is a rare cancer with limited treatment strategies beyond first-line platinum-based combination therapy and no established second-line standard. Our recent retrospective study showed that Nectin-4 is frequently highly expressed in SBA and is associated with poorer outcomes, providing a biological rationale for evaluating enfortumab vedotin-a Nectin-4-targeted antibody-drug conjugate. We designed ENVELOPE to evaluate enfortumab vedotin in advanced SBA refractory or intolerant to platinum-based chemotherapy.
TRIAL DESIGN: ENVELOPE is a multicenter, single-arm, phase II investigator-initiated trial. Representative eligibility criteria include adults with histologically or cytologically confirmed SBA, measurable disease, Eastern Cooperative Oncology Group performance status 0-1, and prior FOLFOX or CapeOX with progression or intolerance. Enfortumab vedotin is administered at 1.25 mg/kg intravenously on days 1, 8, and 15 of each 28-day cycle until progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR) by blinded independent central review. The null and expected ORRs are 5% and 25%, respectively; an exact binomial design (one-sided alpha = 5%; 90% power) requires 25 assessable patients (planned N = 27). A prospective translational program requires pretreatment tumor tissue, prespecifies Nectin-4 immunohistochemistry as the exploratory biomarker, and collects on-study biopsies/serial blood at baseline, on treatment, and at progression for multi-omics profiling.
TRIAL DESIGN: ENVELOPE is a multicenter, single-arm, phase II investigator-initiated trial. Representative eligibility criteria include adults with histologically or cytologically confirmed SBA, measurable disease, Eastern Cooperative Oncology Group performance status 0-1, and prior FOLFOX or CapeOX with progression or intolerance. Enfortumab vedotin is administered at 1.25 mg/kg intravenously on days 1, 8, and 15 of each 28-day cycle until progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR) by blinded independent central review. The null and expected ORRs are 5% and 25%, respectively; an exact binomial design (one-sided alpha = 5%; 90% power) requires 25 assessable patients (planned N = 27). A prospective translational program requires pretreatment tumor tissue, prespecifies Nectin-4 immunohistochemistry as the exploratory biomarker, and collects on-study biopsies/serial blood at baseline, on treatment, and at progression for multi-omics profiling.