Phase 1
Completed N=43
Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations
Source: ClinicalTrials.gov NCT03835533 ↗Enrolled (actual)
43
Serious AEs
37.2%
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — 14; 15; 13; 7 Participants
Summary
This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of immunotherapy combinations in participants with mCRPC who have received prior secondary androgen receptor signaling inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
14; 15; 13; 7; 4; 5 | — |
| SECONDARY Composite Response Rate (CRR) |
1; 5; 1 | — |
| SECONDARY Disease Control Rate (DCR) |
2; 5; 2 | — |
| SECONDARY Radiographic Progression-free Survival (rPFS) |
2.8; 7.5; 3.2 | — |
| SECONDARY Overall Survival (OS) |
NA; 20.6; 17.3 | — |
| SECONDARY Overall Survival (OS) at 12 Months |
0.579; 0.525; 0.524 | — |
Eligibility Criteria
Key Inclusion Criteria
- Metastatic castration resistant prostate cancer with castrate-level testosterone ( 10 mg/day prednisone (or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study intervention. Inhaled steroids are permitted if necessary.
- Has any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, controlled autoimmune hypothyroidism, psoriasis not requiring systemic treatment, or other conditions under control are permitted to enroll.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS), or any positive test for hepatitis B or hepatitis C virus representing acute or chronic disease.
- Has received a live vaccine within 30 days of planned start of study intervention.
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study intervention. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Data sourced from ClinicalTrials.gov (NCT03835533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.