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A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC).

OBJECTIVE AND HYPOTHESISPrimary ObjectiveThe primary objective is to determine whether abiraterone acetate in combination with low-doseprednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS insubjects…

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING IPILIMUMAB VS. PLACEBO FOLLOWING RADIOTHERAPY IN SUBJECTS WITH CASTRATION RESISTANT PROSTATE CANCER THAT HAVE RECEIVED PRIOR TREATMENT WITH DOCETAXEL

The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…

A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen
receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer

PrimaryDemonstration of superior efficacy (as measured by PFS time) of L-BLP25 in combination with hormonal treatment (HT) over placebo plus HT, when used for first-line therapy of hormone receptor-positive (ER+ and/or PgR+), inoperable locally…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

To estimate the treatment effect and safety of AMG 386 in combination with paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer.

The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

This study has been transitioned to CTIS with ID 2022-500785-10-00 check the CTIS register for the current data. 1) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)2) To compare…

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival (OS)

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)

This study has been transitioned to CTIS with ID 2023-504998-20-00 check the CTIS register for the current data. - To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free…

A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) plus Carboplatin-paclitaxel versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY)

This study has been transitioned to CTIS with ID 2023-506551-23-00 check the CTIS register for the current data. This study has two parts. The purpose of the first part of the study is to investigate if the investigational drug called dostarlimab (…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER

This study has been transitioned to CTIS with ID 2024-510605-28-00 check the CTIS register for the current data. Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III…

A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…

Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery.

Primary Objective: This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestrogen for postmenopausal women undergoing POP surgery. In this trial, the perioperative use of oestrogen is considered superior to…

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)

This study has been transitioned to CTIS with ID 2023-506177-35-00 check the CTIS register for the current data. Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab,…

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Primary ObjectiveTo determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of…

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy

This study has been transitioned to CTIS with ID 2023-506153-38-00 check the CTIS register for the current data. The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical…