Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial

2017 ◽  
Vol 18 (9) ◽  
pp. 1261-1273 ◽  
Author(s):  
Michele Maio ◽  
Arnaud Scherpereel ◽  
Luana Calabrò ◽  
Joachim Aerts ◽  
Susana Cedres Perez ◽  
...  
Keyword(s):  
Malignant Mesothelioma ◽  
Line Treatment ◽  
Second Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Line ◽  
Third Line Treatment

Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 8502-8502 ◽  
Author(s):  
Hedy L. Kindler ◽  
Arnaud Scherpereel ◽  
Luana Calabrò ◽  
Joachim Aerts ◽  
Susana Cedres Perez ◽  
...  
Keyword(s):  
Malignant Mesothelioma ◽  
Line Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Line ◽  
Third Line Treatment

Third-line treatment: A randomized, double-blind, placebo-controlled phase III ALTER-0303 study—Efficacy and safety of anlotinib treatment in patients with refractory advanced NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9053-9053 ◽  
Author(s):  
Baihui Han ◽  
Kai Li ◽  
Qiming Wang ◽  
Yizhuo Zhao ◽  
Li Zhang ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Advanced Nsclc ◽  
Phase Iii ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Line ◽  
Ecog Ps ◽  
Third Line Treatment

9053 Background: Anlotinib hydrochloride, an oral TKI targeting VEGFR, FGFR, PDGFR and c-Kit, showed promising efficacy in PhaseⅡstudy. Here, we evaluated the efficacy and safety of anlotinib as third-line treatment for advanced NSCLC, a randomized, double-blind, placebo-controlled Phase Ⅲtrial (ALTER-0303). Methods: Eligible ⅢB/Ⅳ NSCLC pts who progressed after at least 2 lines of prior therapies were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. Enrolled pts harboring EGFR or ALK mutations must had failed in previous match-targeted therapies. The primary endpoint is OS; secondary endpoint includes PFS, DCR and ORR. Results: As of Aug 2016, total of 437 pts from 31 sites were randomized. The baseline characteristics of Anlotinib arm (N=294) and placebo arm (N=143) were well balanced in the age, gender, ECOG PS and gene states. With 292 OS events (66.82%), significant superiorities in OS, PFS, DCR and ORR were observed in Anlotinib arm according to investigator-assessed results. Grade ≥ 3 treatment-related AEs were hypertension, dermal toxicity and hypertriglyceridemia. There was no treatment–related death in either arm. (Data presented in the Table.) Conclusions: ALTER-0303 trial met its primary endpoint. Anlotinib significantly improved OS and PFS in advanced NSCLC with a manageable safety profile. The results strongly suggest that anlotinib should be considered as a candidate for the third-line treatment or beyond in advanced NSCLC. Clinical trial information: NCT02388919. [Table: see text]

Randomized, double-blind, placebo-controlled study of tremelimumab for second- and third-line treatment of unresectable pleural or peritoneal mesothelioma.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. TPS7609-TPS7609 ◽  
Author(s):  
Michele Maio ◽  
Arnaud Scherpereel ◽  
Alessandra Di Pietro ◽  
Paul Vasey ◽  
Anne S. Tsao ◽  
...  
Keyword(s):  
Peritoneal Mesothelioma ◽  
Controlled Study ◽  
Line Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Third Line ◽  
Third Line Treatment
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