Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants Wit… (NCT06765954) | Clinical Trial Compass
WithdrawnPhase 2
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
Stopped: Study was redeveloped into a new protocol
0Started 2025-12-01
Plain-language summary
This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy. Researchers will track how well the treatment works and how safe it is. The study will last about five years.
Who can participate
Age range18 Years
SexMALE
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The inclusion criteria:
* Age: ≥18 years old.
* Ability to understand and provide informed consent: Participants must be able to understand the study and provide written informed consent fulfilling all relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
* Histologically confirmed prostate adenocarcinoma: A diagnosis confirmed through a pathology report or a clinical course consistent with the disease, as determined by a local pathologist, if a pathology specimen is unavailable.
* ECOG performance status: 0 or 1 (fully active or restricted in strenuous activity but ambulatory).
* Life expectancy: \>5 years.
* Germline testing: Must have germline testing completed at the time of initial diagnosis and, if applicable, at recurrence.
* No evidence of distant metastasis: No evidence of soft tissue disease metastasis (visceral or lymph nodes) on CT/MRI scan.
* No active or organ-threatening autoimmune disease: Participants must not have an active or organ-threatening autoimmune disease.
* High-risk or very high-risk prostate cancer: Based on 2024 NCCN guidelines: PSA \>20 ng/mL or Gleason Grade Group ≥4 or ≥cT3a.
* Adequate hematologic and organ function: Defined by specific laboratory values (ANC, lymphocyte count, platelet count, hemoglobin, INR/aPTT, AST, ALT, alkaline phosphatase) obtained within 14 days prior to baseline, with specific exceptions stated in the protocol for participants with liver or bone metastases or those with known Gi…
What they're measuring
1
Complete Pathologic Response (CPR) after pre-radiation immunotherapy.
Timeframe: CPR: Assessed within approximately 6 weeks of study start.
2
PSA30 response at end-of-treatment (EOT) after post-radiation immunotherapy
Timeframe: Assessed at EOT, which occurs roughly 30 to 39 weeks after the study begins.