Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker

Summary

Explore the association between intensity of 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) at baseline, as measured by mean standardized uptake value (SUVmax) at each lesion, total tumor metabolic volume, measurement of intra-tumoral and inter-lesional heterogeneity, with objective response rate (ORR) at 12 weeks (as defined via RECIST 1.1) to pembrolizumab in patients with treatment-naïve metastatic melanoma.

Timeline

Start

2017-04-19

Primary completion

2021-04-01

Completion

2023-07-01

Outcome

Missed primary endpoint

registry analysis (other test); Baseline C11AMT PET SUVmax<5 vs Baseline C11AMT PET SUVmax>5; p = 0.08; 2-tailed Fisher's exact test NCT03089606 ↗

Publications

• Oldan JD, Giglio BC, Smith E, Zhao W, Bouchard DM, Ivanovic M, Lee YZ, Collichio FA, Meyers MO, Wallack DE, Abernethy-Leinwand A, Long PK, Trembath DG, Googe PB, Kowalski MH, Ivanova A, Ezzell JA, Nikolaishvili-Feinberg N, Thomas NE, Wong TZ, Ollila DW, Li Z, Moschos SJ. Increased tryptophan, but not increased glucose metabolism, predict resistance of pembrolizumab in stage III/IV melanoma. Oncoimmunology. 2023 Apr 26;12(1):2204753. doi: 10.1080/2162402X.2023.2204753. eCollection 2023.

Drugs

Indications