Trial · NCT06765954
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
NCT06765954, Phase 2, Withdrawn, ImmunityBio, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer. Trials, record NCT06765954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06765954
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
- NCT number
- NCT06765954
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- High-risk Prostate Cancer
- Interventions
- N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus), M-CENK (Activated NK Cells), External Beam Radiation Therapy (EBRT), Androgen Deprivation Therapy (ADT), Post-radiation immunotherapy
- First posted
- 2025-01-09
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Pathologic Response (CPR) after pre-radiation immunotherapy. | CPR: Assessed within approximately 6 weeks of study start. | Complete Pathologic Response (CPR) after pre-radiation immunotherapy: Assesses the complete absence of cancer in tissue samples taken after the pre-radiation immunotherapy phase. This signifies a complete eradication of the cancer at that stage of the treatment process. |
| Primary | PSA30 response at end-of-treatment (EOT) after post-radiation immunotherapy | Assessed at EOT, which occurs roughly 30 to 39 weeks after the study begins. | Measures a ≥30% reduction in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. PSA is a common biomarker used to monitor prostate cancer treatment success. A decrease in PSA suggests successful treatment in reducing the cancer burden. |
| Secondary | Clinical Pathologic Response (after pre-radiation immunotherapy) | Within approximately 6 weeks of the study start. | Clinical Pathologic Response (CPR) is an assessment of the extent of tumor reduction after treatment, combining clinical (imaging) and pathological (tissue examination) findings. In this study, CPR is evaluated both after pre-radiation and post-radiation immunotherapy. The specific criteria for determining CPR will vary depending on whether it's assessed by imaging or pathology. |
| Secondary | Time to Recurrence Interval (TTRI) | Variable, ranging from the end of radiation therapy (around 2-9 weeks after pre-radiation immunotherapy, depending on individual schedules) to up to 5 years (260 weeks). | This measures the time elapsed between the completion of radiation therapy and the recurrence of the cancer. Longer TTRI indicates more durable treatment results. |
| Secondary | Safety (AEs and SAEs) | Continuous monitoring throughout the entire study duration (approximately 303 weeks). | Safety will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the study, graded using the CTCAE v5.0 scale. |
| Other | Quality of Life (QoL) | Approximately 5 years | Assessed using validated questionnaires |
| Other | Sexual Function | Approximately 13 Months | Assessed using the Sexual Health Inventory for Men (SHIM) questionnaire. |
| Other | Changes in Immune Subsets and Antigen-Specific Immune Responses | Approximately 13 Months | This evaluates the effects of the treatment on the immune system, looking for changes in various immune cells and their responses to specific cancer antigens. |
| Other | PSA Levels | Approximately 13 months | Prostate-specific antigen (PSA) is a protein produced by the prostate gland. PSA levels in the blood are commonly used as a marker to monitor prostate cancer. |
| Other | Tumor Microenvironment (TME) | Pre-radiation TME: Approximately 6 weeks after study start. Post-radiation TME: Approximately 30-39 weeks after study start. | Evaluated through analysis of tissue samples using whole slide images, spatial transcriptome, immunohistochemistry, and bulk RNA sequencing. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06765954
GET https://conductscience.org/api/trials/v1/NCT06765954/registered