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000284981 245__ $$aNivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial.
000284981 260__ $$a[London]$$bNature Publishing Group UK$$c2023
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000284981 520__ $$aCancer of unknown primary has a dismal prognosis, especially following failure of platinum-based chemotherapy. 10-20% of patients have a high tumor mutational burden (TMB), which predicts response to immunotherapy in many cancer types. In this prospective, non-randomized, open-label, multicenter Phase II trial (EudraCT 2018-004562-33; NCT04131621), patients relapsed or refractory after platinum-based chemotherapy received nivolumab and ipilimumab following TMBhigh vs. TMBlow stratification. Progression-free survival (PFS) represented the primary endpoint; overall survival (OS), response rates, duration of clinical benefit and safety were the secondary endpoints. The trial was prematurely terminated in March 2021 before reaching the preplanned sample size (n = 194). Among 31 evaluable patients, 16% had a high TMB ( > 12 mutations/Mb). Overall response rate was 16% (95% CI 6-34%), with 7.7% (95% CI 1-25%) vs. 60% (95% CI 15-95%) in TMBlow and TMBhigh, respectively. Although the primary endpoint was not met, high TMB was associated with better median PFS (18.3 vs. 2.4 months) and OS (18.3 vs. 3.6 months). Severe immune-related adverse events were reported in 29% of cases. Assessing on-treatment dynamics of circulating tumor DNA using combined targeted hotspot mutation and shallow whole genome sequencing as part of a predefined exploratory analysis identified patients benefiting from immunotherapy irrespective of initial radiologic response.
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000284981 7001_ $$0P:(DE-He78)a3903480c7232195efbd7b0f6f8564e8$$aKraft, Bianca$$b1$$eFirst author$$udkfz
000284981 7001_ $$0P:(DE-He78)de9da69e07eba6d0ca82a4f087a64a28$$aWohlfromm, Timothy$$b2$$udkfz
000284981 7001_ $$aStahl, Michael$$b3
000284981 7001_ $$00000-0001-5000-2328$$aKubuschok, Boris$$b4
000284981 7001_ $$aLöffler, Harald$$b5
000284981 7001_ $$aHacker, Ulrich T$$b6
000284981 7001_ $$aHübner, Gerdt$$b7
000284981 7001_ $$aWeiss, Lena$$b8
000284981 7001_ $$00000-0002-4463-8263$$aBitzer, Michael$$b9
000284981 7001_ $$00000-0003-2147-489X$$aErnst, Thomas$$b10
000284981 7001_ $$aSchütt, Philipp$$b11
000284981 7001_ $$0P:(DE-He78)743a4a82daab55306a2c88b9f6bf8c2f$$aHielscher, Thomas$$b12$$udkfz
000284981 7001_ $$0P:(DE-He78)3e76653311420a51a5faeb80363bd73e$$aDelorme, Stefan$$b13$$udkfz
000284981 7001_ $$aKirchner, Martina$$b14
000284981 7001_ $$aKazdal, Daniel$$b15
000284981 7001_ $$00000-0002-2312-8360$$aBall, Markus$$b16
000284981 7001_ $$aKluck, Klaus$$b17
000284981 7001_ $$00000-0003-1001-103X$$aStenzinger, Albrecht$$b18
000284981 7001_ $$0P:(DE-He78)c741dc7f974390ad4310349f29aac40b$$aBochtler, Tilmann$$b19$$udkfz
000284981 7001_ $$0P:(DE-He78)493c5fbf69f1b20df6f048712f3ad4a0$$aKrämer, Alwin$$b20$$eLast author$$udkfz
000284981 773__ $$0PERI:(DE-600)2553671-0$$a10.1038/s41467-023-42400-5$$gVol. 14, no. 1, p. 6761$$n1$$p6761$$tNature Communications$$v14$$x2041-1723$$y2023
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