INTerpath-004: A phase 2, randomized, doubleblind study of pembrolizumab with V940 (mRNA- 4157) or placebo in the adjuvant treatment of renal cell carcinoma

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Choueiri,T. K.
Powles,T.
Braun,D.
Fong,L.
George,D.
Haas,N.
McDermott,D. F.
Shuch,B.
Gurney,H.
Meehan,R.

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2024

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Background: The PD-1 inhibitor pembrolizumab is approved as monotherapy for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at increased risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions based on results from the phase 3 KEYNOTE-564 trial. Novel combination strategies could provide further clinical benefit in the adjuvant setting. V940 (mRNA-4157) is an individualized neoantigen therapy that is hypothesized to increase the antitumor activity of T cells and enhance the activity of pembrolizumab. V940 plus pembrolizumab showed improved clinical outcomes for stage III/IV melanoma compared with pembrolizumab alone in the phase 2b KEYNOTE-942 study. INTerpath-004 is a global, multicenter, randomized, doubleblind, phase 2 trial (NCT06307431) designed to evaluate the efficacy and safety of adjuvant pembrolizumab with V940 or placebo in patients with RCC who have undergone nephrectomy.

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The Oncologist

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