18 and older, any sex, with Castration-Resistant Prostate Carcinoma or Metastatic Malignant Neoplasm in the Bone. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Adverse EventsPrimary· from date of the first treatment, up to 43.6 months
Toxicity will be monitored in all patients who receive at least one dose of tremelimumab, even if the patient is not evaluable for the biomarker or efficacy endpoint. Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03.
Adverse Events
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
236
Serious Adverse Events
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
14
Prostate-specific Antigen (PSA) Progression Free Survival (PFS)Secondary· from the first day of treatment, up to 43.6 months
PSA PFS is defined as per Prostate Cancer Working Group 3 (PCWG3) criteria: time from start of therapy to first PSA increase of 25% and ≥2 ng/mL above the nadir, and which is confirmed by a second value ≥3 weeks later. PSA PFS were calculated from the first day of treatment and summarized by Kaplan-Meier methods.
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
0.9
0.9 – 1.8
Radiographic Progressive Free Survival (rPFS)Secondary· from first day of treatment, up to 43.6 months
rPFS is measured from first dose to date of disease progression on CT and/or bone scan or death from any cause, whichever occurs first. Radiographic PFS will start at the first day of treatment and will be summarized by Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),as a 20% increase in the sum of the longest diameter of target lesions, or ameasurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
3.7
1.9 – 5.7
Number of Participants With PSA Decline of ≥50% From Start of TherapySecondary· baseline, up to 43.6 months
PSA decline will start at the first day of treatment and will be summarized by Kaplan-Meier. The numeric PSA value at maximal decline will be summarized by a boxplot and as a scatter plot of maximal decline by baseline PSA. PSA is produced by normal and cancerous prostate tissue. PSA levels are often elevated in men with prostate cancer.
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
3
Median Overall SurvivalSecondary· from start of treatment, up to 43.6 months
Overall Survival is the time which begins at diagnosis (or at the start of treatment) and up to the time of death.
Group
Value
95% CI
Treatment (Tremelimumab, Durvalumab)
28.1
14.5 – 37.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose through 30 days after the last dose of medication, up to 43.6 months.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
· Phase 2
· not yet recruiting
Other recruiting trials for Castration-Resistant Prostate Carcinoma
Currently open trials in the same condition.
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX
· Phase 1
· recruiting
NCT06632977 — Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
· Phase 2
· recruiting
NCT06305598 — Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration
· Phase 1
· recruiting
NCT06236139 — Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate
· Phase 1, PHASE2
· recruiting
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 15 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03204812.