A Phase 3 interventional study of PROSTVAC-V and PROSTVAC-F in Prostate Cancer Metastatic, sponsored by Bavarian Nordic. Completed at 220 sites in 16 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 1,297 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bavarian Nordic is the lead sponsor of 55 studies on the registry; 1 is open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
OR
Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
Exclusion Criteria:
Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of \<1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF
Biological: PROSTVAC-V · Biological: PROSTVAC-F · Drug: GM-CSF
* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF placebo
Biological: PROSTVAC-V · Biological: PROSTVAC-F · Other: GM-CSF Placebo
PROSTVAC V/F Placebo + GM-CSF Placebo
Other: GM-CSF Placebo · Biological: Placebo
PROSTVAC V/F Placebo
Overall Survival
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
Time frame: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.
Number of Subjects Alive Without Event at 6 Months
A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.
Time frame: Randomization through Week 25/End of Treatment visit.
Phase 3, randomized, placebo-controlled, multicenter, multi-country efficacy trial of PROSTVAC administered SC to adult males with asymptomatic mCRPC, and was designed to enroll approximately 1200 men. Subjects were randomly assigned with equal probability (1:1:1) to one of three double-blind treatment arms.
| Milestone | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Started | 432 | 432 | 433 |
| Treated | 429 | 429 | 428 |
| Completed | 300 | 279 | 280 |
| Not completed | 132 | 153 | 153 |
| Withdrew: Adverse event | 12 | 18 | 15 |
| Withdrew: Death | 5 | 7 | 3 |
| Withdrew: Lack of efficacy | 89 | 100 | 112 |
| Withdrew: Physician decision | 0 | 2 | 1 |
| Withdrew: Protocol violation | 7 | 5 | 4 |
| Withdrew: Withdrawal by subject | 14 | 16 | 11 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 1 |
| Withdrew: Other per report | 2 | 2 | 1 |
| Withdrew: Randomized but not treated | 3 | 3 | 5 |
| Milestone | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Started | 409 | 408 | 413 |
| Completed | 0 | 0 | 0 |
| Not completed | 409 | 408 | 413 |
| Withdrew: Death | 235 | 239 | 236 |
| Withdrew: Lost to follow-up | 2 | 2 | 3 |
| Withdrew: Withdrawal by subject | 9 | 6 | 6 |
| Withdrew: Study terminated by sponsor | 160 | 158 | 165 |
| Withdrew: Other per report | 3 | 2 | 2 |
| Withdrew: Unknown/missing | 0 | 1 | 1 |
The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
| Months | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Overall Survival | 34.4 (31.0 to 36.9) | 33.2 (30.6 to 37.4) | 34.3 (30.7 to 37.0) |
A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such. Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.
| Participants | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Number of Subjects Alive Without Event at 6 Months | 127 | 121 | 131 |
Collected over Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PROSTVAC-V/F-TRICOM + GM-CSF Placebo | 252/432 (58.3%) | 56/429 (13.1%) | 351/429 (81.8%) |
| PROSTVAC-V/F-TRICOM + GM-CSF | 254/432 (58.8%) | 56/429 (13.1%) | 367/429 (85.5%) |
| Placebo Control | 248/433 (57.3%) | 53/428 (12.4%) | 346/428 (80.8%) |
| Event | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| HaematuriaRenal and urinary disorders | 2/429 | 7/429 | 4/428 |
| Urinary retentionRenal and urinary disorders | 6/429 | 4/429 | 1/428 |
| HydronephrosisRenal and urinary disorders | 5/429 | 1/429 | 2/428 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 5/429 | 1/429 | 0/428 |
| Spinal cord compressionNervous system disorders | 1/429 | 4/429 | 2/428 |
| Atrial fibrillationCardiac disorders | 0/429 | 0/429 | 3/428 |
| Urinary tract infectionInfections and infestations | 1/429 | 3/429 | 1/428 |
| NauseaGastrointestinal disorders | 0/429 | 1/429 | 2/428 |
| UrosepsisInfections and infestations | 2/429 | 0/429 | 2/428 |
| Pathological fractureMusculoskeletal and connective tissue disorders | 0/429 | 1/429 | 2/428 |
| Event | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control |
|---|---|---|---|
| Injection site erythemaGeneral disorders | 201/429 | 256/429 | 200/428 |
| Injection site painGeneral disorders | 109/429 | 128/429 | 119/428 |
| Injection site pruritusGeneral disorders | 77/429 | 109/429 | 57/428 |
| FatigueGeneral disorders | 94/429 | 105/429 | 91/428 |
| Injection site swellingGeneral disorders | 73/429 | 101/429 | 67/428 |
| PyrexiaGeneral disorders | 37/429 | 91/429 | 53/428 |
| Injection site indurationGeneral disorders | 46/429 | 67/429 | 58/428 |
| Back painMusculoskeletal and connective tissue disorders | 62/429 | 43/429 | 48/428 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 49/429 | 50/429 | 55/428 |
| Influenza like illnessGeneral disorders | 44/429 | 55/429 | 36/428 |
Intent to treat, including all randomized subjects.
| Age, Categorical(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 104 | 121 | 109 | 334 |
| >=65 years | 328 | 311 | 324 | 963 |
| Age, Continuous(years) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| Mean | 71.3 ± 8.00 | 70.6 ± 8.42 | 71.4 ± 8.33 | 71.1 ± 8.25 |
| Sex: Female, Male(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 432 | 432 | 433 | 1297 |
| Ethnicity (NIH/OMB)(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 11 | 11 | 18 | 40 |
| Not Hispanic or Latino | 418 | 421 | 415 | 1254 |
| Unknown or Not Reported | 3 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 7 | 6 | 7 | 20 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 17 | 25 | 23 | 65 |
| White | 404 | 400 | 403 | 1207 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 0 | 3 |
| Region of Enrollment(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| Puerto Rico | 2 | 1 | 2 | 5 |
| United States | 124 | 141 | 129 | 394 |
| United Kingdom | 31 | 29 | 39 | 99 |
| Iceland | 4 | 3 | 3 | 10 |
| Russia | 50 | 52 | 61 | 163 |
| Spain | 45 | 33 | 48 | 126 |
| Canada | 30 | 13 | 26 | 69 |
| Netherlands | 6 | 4 | 6 | 16 |
| Belgium | 12 | 8 | 10 | 30 |
| Denmark | 34 | 42 | 32 | 108 |
| Poland | 6 | 9 | 5 | 20 |
| Israel | 13 | 11 | 5 | 29 |
| Australia | 36 | 38 | 27 | 101 |
| France | 29 | 28 | 28 | 85 |
| Germany | 3 | 13 | 6 | 22 |
| Estonia | 7 | 7 | 6 | 20 |
| Randomization Stratum(Participants) | PROSTVAC-V/F-TRICOM + GM-CSF Placebo | PROSTVAC-V/F-TRICOM + GM-CSF | Placebo Control | Total |
|---|---|---|---|---|
| PSA < 50 ng/mL and LDH < 200 U/L | 168 | 168 | 168 | 504 |
| PSA < 50 ng/mL and LDH >= 200 U/L | 135 | 135 | 135 | 405 |
| PSA >= 50 ng/mL and LDH < 200 U/L | 65 | 64 | 64 | 193 |
| PSA >= 50 ng/mL and LDH >= 200 U/L | 64 | 65 | 66 | 195 |
Showing the first 100 of 220 sites across 16 countries.
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