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BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer.

Publication ,  Conference
Mettu, NB; Niedzwiecki, D; Boland, PM; Fakih, M; Arrowood, C; Bolch, E; Hurwitz, H; Grothey, A
Published in: Journal of Clinical Oncology
February 1, 2018

TPS873 Background: Initial treatment of metastatic colorectal cancer (mCRC) involves a 5-fluorouracil based chemotherapy regimen, often in combination with anti-VEGF therapy. Upon disease progression, multiple studies have suggested a benefit for continued anti-VEGF therapy. There is increasing evidence that VEGF plays a role in cancer immune evasion. Targeting of inflammatory and immune checkpoints are attractive approaches to enhance the benefits of anti-VEGF therapy. The safety and activity of the anti-PD-L1 antibody atezolizumab with bevacizumab and with 5-FU, oxaliplatin, and bevacizumab have been recently reported; the combinations were well-tolerated and suggested clinical activity. Therefore, bevacizumab may increase the immunogenicity of colorectal cancers, and the combination of atezolizumab plus bevacizumab may be associated with clinically meaningful response rates and disease control. Furthermore, there may be candidate biomarkers that may identify those patients most likely to benefit from this combination. Methods: In this randomized, double-blind, multicenter, placebo-controlled phase II study, 135 patients with mCRC will be randomized 2:1 to receive capecitabine/bevacizumab/atezolizumab or capecitabine/bevacizumab/placebo. Patients with prior PD-L1/PD-1 therapy are ineligible. Primary and secondary efficacy will be conducted using ITT analysis. Safety analyses will include all randomized patients who receive at least one dose of study treatment. The primary objective is PFS. The secondary objectives are ORR, OS, safety, and tolerability. The primary comparison will be superiority of the active treatment for the PFS endpoint, atezolizumab versus placebo testing at 1-sided α = 0.1 (log rank test). A PFS hazard ratio of 0.618 (active treatment versus placebo) is detectable with 86% power (1 sided α = 0.1). No interim analyses for futility or efficacy will be conducted. A subset analysis will be performed in the microsatellite-high patients looking at potential differences in PFS and OS. Trial is active and currently recruiting patients. Clinical trial information: NCT02873195.

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

February 1, 2018

Volume

36

Issue

4_suppl

Start / End Page

TPS873 / TPS873

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mettu, N. B., Niedzwiecki, D., Boland, P. M., Fakih, M., Arrowood, C., Bolch, E., … Grothey, A. (2018). BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer. In Journal of Clinical Oncology (Vol. 36, pp. TPS873–TPS873). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2018.36.4_suppl.tps873
Mettu, Niharika B., Donna Niedzwiecki, Patrick McKay Boland, Marwan Fakih, Christy Arrowood, Emily Bolch, Herbert Hurwitz, and Axel Grothey. “BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer.” In Journal of Clinical Oncology, 36:TPS873–TPS873. American Society of Clinical Oncology (ASCO), 2018. https://doi.org/10.1200/jco.2018.36.4_suppl.tps873.
Mettu NB, Niedzwiecki D, Boland PM, Fakih M, Arrowood C, Bolch E, et al. BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2018. p. TPS873–TPS873.
Mettu, Niharika B., et al. “BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer.Journal of Clinical Oncology, vol. 36, no. 4_suppl, American Society of Clinical Oncology (ASCO), 2018, pp. TPS873–TPS873. Crossref, doi:10.1200/jco.2018.36.4_suppl.tps873.
Mettu NB, Niedzwiecki D, Boland PM, Fakih M, Arrowood C, Bolch E, Hurwitz H, Grothey A. BACCI: A phase II randomized, double-blind, placebo-controlled study of capecitabine bevacizumab plus atezolizumab versus capecitabine bevacizumab plus placebo in patients with refractory metastatic colorectal cancer. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2018. p. TPS873–TPS873.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

February 1, 2018

Volume

36

Issue

4_suppl

Start / End Page

TPS873 / TPS873

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences