Immunotherapy Clinical Trial
Official title:
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor. Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
| Recruiting |
NCT06165900 -
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
|
Phase 2 | |
| Recruiting |
NCT06120127 -
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
|
Phase 2 | |
| Recruiting |
NCT06262581 -
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery
|
Phase 2 | |
| Recruiting |
NCT05176002 -
Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
| Recruiting |
NCT04500990 -
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
|
||
| Not yet recruiting |
NCT04372732 -
Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
|
||
| Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
| Completed |
NCT03763630 -
MAPS & ITEC Cohorts: 6-8 Years Follow-up
|
Phase 2 | |
| Not yet recruiting |
NCT06012318 -
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
|
||
| Not yet recruiting |
NCT05479240 -
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
|
Phase 2 | |
| Recruiting |
NCT04711330 -
Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
|
||
| Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
| Recruiting |
NCT03683407 -
Effect of Chemotherapy on TMB in NSCLC
|
||
| Recruiting |
NCT03701607 -
Effect of Chemotherapy on PD-L1 in NSCLC
|
||
| Completed |
NCT03357861 -
Cancer Patients Treated With Immunotherapy in Intensive Care Unit
|
||
| Recruiting |
NCT05223088 -
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
|
Phase 2 | |
| Completed |
NCT05657262 -
Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas
|
N/A | |
| Recruiting |
NCT05621356 -
Monitoring Allergen Immunotherapy in Allergic Rhinitis
|