Clinical Trials List
Protocol NumberCA209-7DX
NCT Number(ClinicalTrials.gov Identfier)NCT04100018
2020-04-01 - 2024-01-10
Phase III
Recruiting6
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tzu-Ping Lin 無
- 沈書慧 無
- Chih-Chieh Lin 無
- Hsiao-Jen Chung 無
- Tzu-Hao Huang 無
- Tzu-chun Wei 無
- 陳威任 無
- Chien-Hsin Ting 無
- Yen-Hwa Chang 無
- 潘競成 無
- 朱力行 無
- I-Shen Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Che-Hung Lin 無
- Yi-Huei Chang 無
- Chi-Rei Yang 無
- Chi-Ping Huang 無
- Han Chang 無
- Po-Fan Hsieh 無
- Su-Peng Yeh 無
- 陳冠亨 無
- Ching-Chan Lin 無
- Hsi-Chin Wu 無
- Wei-Ching Lin 無
- Po-Jen Hsiao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yeong-Shiau Pu 無
- YU-CHUAN LU 無
- CHING-CHU LU 無
- CHUNG-HSIN CHEN 無
- JHE-CYUAN GUO 無
- 王中傑 無
- PO-MING CHOW 無
- FU-JEN HSUEH 無
- - - 無
- Ying-Chun Shen 無
- 陳育青 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wu-Chou Su 無
- Che-Yuan Hu 無
- Jiann-Hui Ou 無
- Yuh-Shyan Tsai 無
- 楊舜如 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shian-Shiang Wang 無
- Cheng-Kuang Yang 無
- 王樹吉 無
- 熊小澐 無
- Chuan-Shu Chen 無
- 洪晟鈞 無
- 張瓈文 無
- 蔡世傳 無
- 盧嘉文 無
- Chia-Yen Lin 無
- 梅承恩 無
- 裘坤元 無
- Jian-Ri Li 無
- 林雁婷 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Castration-resistant Prostate Cancer
Objectives
Primary Objective
To compare the rPFS (using PCWG3) of
nivolumab in combination with docetaxel to
placebo in combination with docetaxel, in
men with metastatic castration resistant
prostate cancer (mCRPC).
To compare the OS of nivolumab in
combination with docetaxel to placebo in
combination with docetaxel, in men with
metastatic castration resistant prostate cancer
(mCRPC).
Secondary Objective
To assess the antitumor activity of nivolumab
in combination with docetaxel
To characterize the safety and tolerability of
nivolumab in combination with docetaxel.
To evaluate the progression of pain during
treatment.
Exploratory Objective
To investigate the time to initiation of
subsequent systemic therapy (TT-SST)
To investigate the time to first symptomatic
skeletal event (TT-SSE)
To evaluate the change in pain intensity and
health-related cancer related symptoms and
quality of life
To assess the participant’s quality of life and
overall health status
To investigate the time to and duration of PSA
response
To explore the circulating tumor cell count
conversion rate (CTC-CR) and CTC0 at Week
13.
To evaluate the pharmacokinetics of
nivolumab when administered in combination
with docetaxel. To explore exposure response
relationships between select exposure
measures, and safety, and efficacy endpoints,
as appropriate.
To characterize the immunogenicity of
nivolumab when administered in combination
with docetaxel.
To evaluate the immunomodulatory activity of
nivolumab when administered in combination
with docetaxel as measured by flow cytometric
analyses of peripheral blood mononuclear cells
(PBMCs), myeloid derived suppressor cells,
and serum soluble factor analysis.
To evaluate the association between
biomarkers in the peripheral blood (eg,
CXCL9, CXCL10, gamma interferon
signature) and tumor tissue and treatment
efficacy.
Test Drug
OPDIVO (nivolumab) Injection 10mg/mL
Active Ingredient
Nivolumab
Dosage Form
IVT
Dosage
10mg/mL
Endpoints
Primary Outcome Measures :
Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 2 years ]
Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 3 years. For participants who are alive, their survival time will be censored at the last date that they were known to be alive ]
Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 2 years ]
Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 3 years. For participants who are alive, their survival time will be censored at the last date that they were known to be alive ]
Inclution Criteria
Inclusion Criteria:
Histologic confirmation of adenocarcinoma of the prostate without small cell features
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)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
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
Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides
Men must agree to follow specific methods of contraception, if applicable
Histologic confirmation of adenocarcinoma of the prostate without small cell features
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)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
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
Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides
Men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
Exclusion Criteria:
Prior malignancy active within the previous 3 years (i.e. participants with a history of prior malignancy are eligible if treatment was completed at least 3 years before enrollment) except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
Active brain metastases
Active, known, or suspected autoimmune disease
Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
Prior malignancy active within the previous 3 years (i.e. participants with a history of prior malignancy are eligible if treatment was completed at least 3 years before enrollment) except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
Active brain metastases
Active, known, or suspected autoimmune disease
Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
The Estimated Number of Participants
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Taiwan
34 participants
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Global
984 participants
