Research & Events
FDA approvals, clinical trial results, and breakthrough designations — explained simply.
Filters (262 events)
Phase 3 Trial Results: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Phase 3 clinical trial (NCT01272037) sponsored by National Cancer Institute (NCI). Conditions: Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma. Interventions: Anastrozole (DRUG), Exemestane (DRUG), Laboratory Biomarker Analysis (OTHER). Primary outcomes: Invasive Disease-Free Survival (IDFS). Enrolled 5,018 participants.
Phase 3 Trial Results: Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
Phase 3 clinical trial (NCT03055013) sponsored by National Cancer Institute (NCI). Conditions: Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7. Interventions: Nephrectomy (PROCEDURE), Nivolumab (BIOLOGICAL), Patient Observation (OTHER). Primary outcomes: Recurrence-free Survival (RFS) Rate at 5 Years. Enrolled 819 participants.
Phase 3 Trial Results: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Phase 3 clinical trial (NCT03522246) sponsored by pharmaand GmbH. Conditions: Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer. Interventions: Rucaparib (DRUG), Nivolumab (DRUG), Placebo Oral Tablet (DRUG). Primary outcomes: Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS); Monotherapy Arm B and Arm D: Investigator Assessed PFS; Combination Therapy Arm A and Arm B: Investigator Assessed PFS. Enrolled 1,097 participants.
Phase 3 Trial Results: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Phase 3 clinical trial (NCT03470922) sponsored by Bristol-Myers Squibb. Conditions: Melanoma. Interventions: Relatlimab (BIOLOGICAL), Nivolumab (BIOLOGICAL). Primary outcomes: Progression Free Survival (PFS). Enrolled 714 participants.
Phase 3 Trial Results: A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
Phase 3 clinical trial (NCT03246529) sponsored by BioLineRx, Ltd.. Conditions: Multiple Myeloma. Interventions: BL-8040 1.25 mg/kg + G-CSF (DRUG), Placebo +G-CSF (DRUG). Primary outcomes: Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions. Enrolled 180 participants.
Phase 3 Trial Results: RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
Phase 3 clinical trial (NCT00956007) sponsored by Radiation Therapy Oncology Group. Conditions: Head and Neck Cancer. Interventions: cetuximab (BIOLOGICAL), intensity-modulated radiation therapy (RADIATION). Primary outcomes: Percentage of Participants Alive (Overall Survival). Enrolled 702 participants.
Phase 3 Trial Results: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Phase 3 clinical trial (NCT03975647) sponsored by Seagen, a wholly owned subsidiary of Pfizer. Conditions: HER2-positive Breast Cancer. Interventions: tucatinib (DRUG), placebo (DRUG), T-DM1 (DRUG). Primary outcomes: Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment. Enrolled 466 participants.
Phase 3 Trial Results: Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Phase 3 clinical trial (NCT03573401) sponsored by Biofrontera Inc.. Conditions: Superficial Basal Cell Carcinoma. Interventions: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (COMBINATION_PRODUCT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (COMBINATION_PRODUCT). Primary outcomes: Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion.. Enrolled 187 participants.
Phase 3 Trial Results: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Phase 3 clinical trial (NCT03052608) sponsored by Pfizer. Conditions: Carcinoma, Non-Small-Cell Lung. Interventions: Lorlatinib (DRUG), Crizotinib (DRUG). Primary outcomes: Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment. Enrolled 296 participants.
Phase 3 Trial Results: Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Phase 3 clinical trial (NCT01844986) sponsored by AstraZeneca. Conditions: Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV. Interventions: Olaparib 300mg tablets (DRUG). Primary outcomes: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Enrolled 450 participants.
Phase 3 Trial Results: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
Phase 3 clinical trial (NCT04680052) sponsored by Incyte Corporation. Conditions: Follicular Lymphoma, Marginal Zone Lymphoma. Interventions: tafasitamab (DRUG), rituximab (DRUG), lenalidomide (DRUG). Primary outcomes: FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First; FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First. Enrolled 654 participants.
Phase 3 Trial Results: Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
Phase 3 clinical trial (NCT00392327) sponsored by Children's Oncology Group. Conditions: Anaplastic Medulloblastoma, Medulloblastoma. Interventions: Biospecimen Collection (PROCEDURE), Carboplatin (DRUG), Cisplatin (DRUG). Primary outcomes: Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma; Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET). Enrolled 379 participants.
Phase 3 Trial Results: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Phase 3 clinical trial (NCT05587296) sponsored by Bayer. Conditions: Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes. Interventions: Elinzanetant (BAY3427080) (DRUG), Placebo (DRUG). Primary outcomes: Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]); Mean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD). Enrolled 474 participants.
Phase 3 Trial Results: A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
Phase 3 clinical trial (NCT05654623) sponsored by Pfizer. Conditions: Advanced Breast Cancer. Interventions: ARV-471 (DRUG), Fulvestrant (DRUG). Primary outcomes: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants; PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation. Enrolled 624 participants.
Phase 3 Trial Results: Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Phase 3 clinical trial (NCT01190930) sponsored by Children's Oncology Group. Conditions: Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma, Ann Arbor Stage I B Lymphoblastic Lymphoma. Interventions: Cyclophosphamide (DRUG), Cytarabine (DRUG), Dexamethasone (DRUG). Primary outcomes: Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization; DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization; DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens. Enrolled 9,350 participants.
Phase 3 Trial Results: A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Phase 3 clinical trial (NCT04971226) sponsored by Novartis Pharmaceuticals. Conditions: Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive. Interventions: Imatinib (DRUG), Nilotinib (DRUG), Bosutinib (DRUG). Primary outcomes: Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI; Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum). Enrolled 406 participants.
Phase 3 Trial Results: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
Phase 3 clinical trial (NCT02477696) sponsored by Acerta Pharma BV. Conditions: Chronic Lymphocytic Leukemia. Interventions: Acalabrutinib (DRUG), Ibrutinib (DRUG). Primary outcomes: Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment. Enrolled 533 participants.
Phase 3 Trial Results: A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
Phase 3 clinical trial (NCT01946204) sponsored by Aragon Pharmaceuticals, Inc.. Conditions: Prostatic Neoplasms. Interventions: Apalutamide (DRUG), Placebo (DRUG). Primary outcomes: Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR). Enrolled 1,207 participants.
Phase 3 Trial Results: A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Phase 3 clinical trial (NCT02489318) sponsored by Aragon Pharmaceuticals, Inc.. Conditions: Prostate Cancer. Interventions: Apalutamide (DRUG), Placebo (DRUG), Androgen Deprivation Therapy (ADT) (DRUG). Primary outcomes: Radiographic Progression-free Survival (rPFS); Overall Survival (OS). Enrolled 1,052 participants.
Phase 3 Trial Results: An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Phase 3 clinical trial (NCT02257736) sponsored by Aragon Pharmaceuticals, Inc.. Conditions: Prostatic Neoplasms. Interventions: Apalutamide (DRUG), Abiraterone acetate (DRUG), Prednisone (DRUG). Primary outcomes: Radiographic Progression-free Survival (rPFS). Enrolled 982 participants.