Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

Summary

This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

Timeline

Start

2017-12-21

Primary completion

2021-06-07

Completion

2022-12-20

Publications

• Wheatley DA, Berardi R, Climent Duran MA, Tomiak A, Greystoke AP, Joshua AM, Arkenau HT, Geczi L, Corbacho JG, Paz-Ares LG, Hussain SA, Petruzelka L, Delmonte A, Chappey C, Masters JC, Michelon E, Murphy DA, Mwewa S, Cesari R, Doger de Speville B. First-line Avelumab plus Chemotherapy in Patients with Advanced Solid Tumors: Results from the Phase Ib/II JAVELIN Chemotherapy Medley Study. Cancer Res Commun. 2024 Jun 28;4(6):1609-1619. doi: 10.1158/2767-9764.CRC-23-0459.

Drugs

Indications