Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04989946 | Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer | PHASE1 | RECRUITING | 60 | — | — | Dec 16, 2021 | Dec 1, 2028 | Jan 28, 2026 | 1 | United States |
The pathological complete response will be estimated for each arm and reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method. Formal comparisons between arms will be conducted using Fisher's exact test. Participants in this study with unknown pathological response will be treated as non-responders in the primary analysis.
The MRD rate will be estimated for each arm and reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method. Formal comparisons between arms will be conducted using Fisher's exact test. Participants in this study with unknown pathological response will be treated as non-responders in the primary analysis.
Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
Toxicity rates (grade 2, grade 3, grade 4, grade ≥ 2, grade ≥ 3, etc.) will be calculated for each study arm and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Degarelix | ACTIVE_COMPARATOR | \- Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 |
| Arm 2: Degarelix and pTVG-AR | EXPERIMENTAL | * Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 * pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 |
| Arm 3: Degarelix and pTVG-AR and Nivolumab | EXPERIMENTAL | * Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 * pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 * Nivolumab 240 mg IV administered at days 29, 43, 57 and 71 |
| Arm 4: Degarelix and pTVG-AR and Cemiplimab | EXPERIMENTAL | * Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 * pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 * Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64 |
| Arm 5: Degarelix and pTVG-AR and Cemiplimab and Fianlimab | EXPERIMENTAL | * Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 * pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 * Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64 * Fianlimab 1600 mg IV administered at days 1, 22, 43 and 64 |
| Name | Type | Description |
|---|---|---|
| Degarelix | DRUG | standard Gonadotropin-releasing hormone (GnRH) antagonist |
| pTVG-AR | BIOLOGICAL | DNA vaccine encoding androgen receptor ligand-binding domain |
| Nivolumab | DRUG | Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer. |
| Cemiplimab | DRUG | Cemiplimab is a human PD-1 blocking antibody approved for the treatment of patients with non-small cell lung cancer, cutaneous squamous cell carcinoma, and locally advanced basal cell carcinoma. |
| Fianlimab | DRUG | Lymphocyte activation gene-3 (LAG-3) is a protein that is upregulated on activated CD4+ and CD8+ T cells following T-cell receptor engagement. Binding of LAG-3 to MHC II on professional antigen-presenting cells suppresses the proliferation, activation, and cytokine secretion of T cells. Fianlimab is a human IgG4 antibody to lymphocyte activation gene-3 (LAG-3) that blocks LAG-3/MHC II-mediated T-cell inhibition. |
| FLT PET/CT | DRUG | Arms 1-3 only, FLT PET/CT scan at baseline (within 1-6 days of Day 1) and Day 43 |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Patients must be considered candidates for prostatectomy as per standard of care * High-risk patients for recurrent disease, with high risk defined based on one of the following criteria: * Gleason score 7 and baseli...