-
A Phase 3 Trial Investigating Blinatumomab (IND#117467 NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma(B-LLy)
The purpose of the trial is to determine the safety and efficacy of the investigational medicine, blinatumomab plus standard treatment for patients who have Standard ... -
ACNS1831: A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
The purpose of the study is to compare the efficacy of two treatments. The purpose is to determine whether the efficacy of treatment with selumetinib ... -
AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494 NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL Mixed Phenotype Acute Leukemia and Disseminated B-LLy
The purpose of the study is to determine the safety and efficacy of the investigational medicine Inotuzumab Ozogamicin for patients who have NCI high risk ... -
AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494 NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL Mixed Phenotype Acute Leukemia and Disseminated B-LLy
The primary aim of this study is to assess in a randomized fashion whether or not the incorporation of two cycles of inotuzumab ozogamicin (InO ... -
An Open-label Single-arm Single-dose Prospective Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases after Radiation Therapy
The purpose of the study is to determine the diagnostic performance of 18F-Fluciclovine Positron Emission Tomography (PET) in detecting recurrent brain metastases after radiation therapy ... -
A Phase 3 Randomized Comparator-controlled Study of the Efficacy and Safety of Pembro in Comb. with BCG in Participants with HR Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction
The purpose of the study is to test the safety of the study drugs, pembrolizumab in combination with Bacillus Calmette-Guerin (BCG) and we want to ... -
An open-label randomized controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
The purpose of the study is to evaluate the combination of enfortumab vedotin + pembrolizumab, with or without platinum-containing chemotherapy, versus standard of care gemcitabine + platinum-containing ... -
A Pivotal Randomized Open-Label Study of Optune (TTFields 200khz) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
The purpose of the study is to test the effectiveness and safety of TTFields given to newly diagnosed glioblastoma patients, concomitantly with radiation therapy and ... -
A Randomized Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy Compared with Carboplatin-Pemetrexed in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of the study is to demonstrate the improved efficacy of combining amivantamab with standard of care carboplatin-pemetrexed chemotherapy compared with carboplatin-pemetrexed chemotherapy in ... -
A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab for Stage IIIB or IV Non-Small Cell Lung Cancer
The purpose of the study is to evaluate niraparib plus pembrolizumab versus placebo plus pembrolizumab in participants with advanced or metastatic nonsmall cell lung cancer ...