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The CheckMate 9DX and EMERALD 1 and 2 Trials

Insights From: Riccardo Lencioni MD, University of Miami Health System
Published: Monday, May 13, 2019



Transcript: 

Riccardo Lencioni, MD: EMERALD 1 is the first large prospective randomized phase III trial investigating the combination of chemoembolization, or TACE [transarterial chemoembolization], and immune checkpoint inhibitors. This is a trial that has 3 treatment arms. The first one includes durvalumab, bevacizumab, and chemoembolization. The second arm includes durvalumab and chemoembolization. The third arm is chemoembolization alone because for this patient population, with disease limited to the liver unsuitable for radical therapy with surgery or ablation, chemoembolization is the standard of care. So the primary endpoint of this study would be progression-free survival for the combination of TACE and durvalumab versus TACE alone. And secondary endpoints include assessment of progression-free survival for the combination of durvalumab, bevacizumab, and TACE versus TACE alone, as well as additional analysis, including of course overall survival.

EMERALD 2 is a trial designed in the adjuvant settings. So this prospective randomized phase III study will recruit patients who received curative therapy with surgical resection or local ablation. These patients will be randomized to receive, in 1 arm, durvalumab and bevacizumab, in another arm, durvalumab alone. And the third arm is placebo. Currently, there is no established adjuvant regimen in place for this patient population. The primary endpoint will be to assess recurrence-free survival for durvalumab compared with placebo. Secondary endpoints include the assessment of recurrence-free survival for durvalumab and bevacizumab versus placebo, and of course additional secondary endpoints like time to recurrence and others.

CheckMate 9DX is another study in the adjuvant setting. It’s a phase III randomized placebo-controlled study recruiting patients who underwent radical therapy with resection or ablation. And these patients would be randomized to receive nivolumab or placebo with the primary endpoint to assess recurrence-free survival.

Transcript Edited for Clarity
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Transcript: 

Riccardo Lencioni, MD: EMERALD 1 is the first large prospective randomized phase III trial investigating the combination of chemoembolization, or TACE [transarterial chemoembolization], and immune checkpoint inhibitors. This is a trial that has 3 treatment arms. The first one includes durvalumab, bevacizumab, and chemoembolization. The second arm includes durvalumab and chemoembolization. The third arm is chemoembolization alone because for this patient population, with disease limited to the liver unsuitable for radical therapy with surgery or ablation, chemoembolization is the standard of care. So the primary endpoint of this study would be progression-free survival for the combination of TACE and durvalumab versus TACE alone. And secondary endpoints include assessment of progression-free survival for the combination of durvalumab, bevacizumab, and TACE versus TACE alone, as well as additional analysis, including of course overall survival.

EMERALD 2 is a trial designed in the adjuvant settings. So this prospective randomized phase III study will recruit patients who received curative therapy with surgical resection or local ablation. These patients will be randomized to receive, in 1 arm, durvalumab and bevacizumab, in another arm, durvalumab alone. And the third arm is placebo. Currently, there is no established adjuvant regimen in place for this patient population. The primary endpoint will be to assess recurrence-free survival for durvalumab compared with placebo. Secondary endpoints include the assessment of recurrence-free survival for durvalumab and bevacizumab versus placebo, and of course additional secondary endpoints like time to recurrence and others.

CheckMate 9DX is another study in the adjuvant setting. It’s a phase III randomized placebo-controlled study recruiting patients who underwent radical therapy with resection or ablation. And these patients would be randomized to receive nivolumab or placebo with the primary endpoint to assess recurrence-free survival.

Transcript Edited for Clarity
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