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ESMO 2020

ESMO Virtual Congress 2020: A Phase 3, Randomized, Double-Blind Trial of Nivolumab or Placebo Combined with Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer (CheckMate 7DX)

(UroToday.com) This poster detailed the phase 3 randomized, double-blind, multi-center ChekMate 7DX (NCT03100018) trial of nivolumab in combination with docetaxel chemotherapy in men with metastatic castration-resistant prostate cancer (mCRPC). The rationale for this combination comes from preclinical and clinical evidence that docetaxel may promote antitumor immune responses by increasing tumor antigen presentation, promoting the production of inflammatory cytokines, and downregulating immunosuppressive T cells. As prostate cancer is generally viewed as an immune “cold” tumor with the limited activity of immune checkpoint blockade, docetaxel may create a tumor milieu that augments the efficacy of immunotherapy. Interim analysis of the 41 patients enrolled on the nivolumab + docetaxel arm of the phase 2 CheckMate 9KD (NCT03338790) trial1 showed an objective response rate of 36.8% and median radiographic progression-free survival of 8.2 months, providing the impetus for proceeding with a randomized phase 3 trial testing the combination in mCRPC.

The schema of the trial is shown below: 

Checkmate7DX_figure1.png

Key eligibility criteria are shown below:

KeyEligibilityCriteria_Table1_690TiP.png


Target enrollment is 984 patients. Study sites are currently open in the United States, Australia, Asia (Japan, Republic of Korea, Singapore), and Europe (Austria, Belgium, Czech Republic, France, Poland, Spain and the United Kingdom).

Presented by: Charles G. Drake, MD, PhD, Professor of Oncology, Urology and Immunology, Director of Genitourinary Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY

Written by: Alok Tewari, MD, PhD, Medical Oncologist at the Dana-Farber Cancer Institute, Boston, MA, 2020 European Society for Medical Oncology Virtual Congress (#ESMO20), September 19th-September 21st, 2020.

Reference: 

  1. Fizazi K., Gonzalez Mella P., Castellano D. "Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD" Annals of Oncology. Volume 30, Supplement 5 October 2019. https://doi.org/10.1093/annonc/mdz394.045