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Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy

StatusCompleted
PhasePhase 1/2
Started2018-10-03
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Trial completed
Study completion confirmed: June 2026 (last estimated December 2026)
2026-03-31
Study Status v27
Primary completion pushed: 2025-12-15 → 2026-06-01
2026-01-27
Study Status v26
Primary completion dateestimated 2025-12→confirmed 2025-12-15
2025-09-30
3 amendments v23-v25
3 re-verifications since 2025-03-14, no change to tracked fields
2024-12-20
Study Status v22
Primary completion date2024-12→2025-12
Completion date2024-12→2026-12
Show 21 earlier versions
2024-08-02
Study Status v21
Re-verified, no change to tracked fields
2024-02-21
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-02-20
Study Status v19
Re-verified, no change to tracked fields
2023-09-21
Study Status, Contacts/Locations v18
Primary completion date2023-12→2024-12
Study sitescontacts updated at 1 of 1 site
2023-04-17
4 amendments v14-v17
4 re-verifications since 2022-01-26, no change to tracked fields
2021-08-13
Study Status v13
Start date2018-09-26→2018-10-03
2021-07-01
Study Status, Study Design, Eligibility v12
Primary completion date2021-12→2023-12
Completion date2021-12→2024-12
Enrollment target34→44
Eligibility criteria+66 characters
[...] ADT Undergoing radiation treatment at Moffitt Cancer Center MustParticipants being treated with nivolumab must have normal organ function as defined in protocol. Males who are sexually active with women of childbearing po [...]
2021-04-06
2 amendments v10-v11
2 re-verifications since 2021-03-01, no change to tracked fields
2021-01-11
Study Status v9
Primary completion date2020-12→2021-12
2020-10-19
Study Status v8
Primary completion date2020-09→2020-12
Completion date2021-09→2021-12
2020-05-22
5 amendments v3-v7
5 re-verifications since 2018-10-22, no change to tracked fields
2018-09-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-11→confirmed 2018-09-26
Study sitesdetails revised at 1 of 1 site
2018-08-14
Study Status v1
Start date2018-08→2018-11
2018-05-18
Original filing
The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.
Trial Details
NCT Number NCT03543189
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Bristol-Myers Squibb
Conditions Prostate Cancer, Prostate Disease
Enrollment 44 participants
Start Date 2018-10-03
Primary Completion 2026-06-19 (estimated)
Study Completion 2026-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-16