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TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician*s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer;patients

Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…

An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator*s Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

The study will look at patients with advanced Non-Small Cell Lung Cancer (NSCLC) whose tumours express a certain type of protein called PD-L1. The research aims to compare a new drug called nivolumab against Investigator's choice of…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas

The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…

A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)

The purpose of this study is to find out if the combination of gemcitabine plus carboplatin and iniparib works better than gemcitabine and carboplatin alone in subjects with stage IV squamous non-small-cell lung cancer (NSCLC) that have not…

An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator*s Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy.

Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and stage IV Non-Small Cell Lung Cancer (NSCLC)

The objective of this phase III study is to compare the efficacy of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line treatment of patients with stage IIIB (with effusion) or Stage…

A PHASE III RANDOMIZED TRIAL OF GEMCITABINE PLUS DOCETAXEL FOLLOWED BY DOXORUBICIN V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.

A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 >=50%

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…

A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…

A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma

Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator*s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant
Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-
Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-
Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2024-512158-12-00 check the CTIS register for the current data. Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized…

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.

To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus platinum doublet chemotherapy versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The study will look at patients with chemotherapy-naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). The research aims to compare a new drug called nivolumab OR nivolumab with ipilimumab (another cancer drug) OR nivolumab combined with…