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A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Status
Closed
Cancer Type
Bone Tumor
Trial Phase
Phase III
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT04100018
Protocol IDs
CA209-7DX (primary)
NCI-2019-08322
2019-002030-36
Study Sponsor
Bristol-Myers Squibb

Summary

The purpose of this study is to assess the safety and effectiveness of nivolumab with
docetaxel in men with advanced castration resistant prostate cancer who have progressed after
second-generation hormonal manipulation.

Eligibility

  1. Histologic confirmation of adenocarcinoma of the prostate without small cell features
  2. Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  5. Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
  6. Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
  7. Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
  8. Men must agree to follow specific methods of contraception, if applicable

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta


340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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