Principal Investigator: Lida Mina Principal Investigator: Shakeela Bahadur, A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies (NCT03598608) Clinical trials testing potential medical products are commonly classified into four phases. Information gathered in each phase determines whether the study can move on to the next phase, and whether the drug or treatment is approved for use. Principal Investigator: Boris Naraev, A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp alfa (M7824) as First-line Treatment of Biliary Tract Cancer (NCT04066491) Principal Investigator: Dr. Jiaxin Niu, A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671) (NCT03425643), A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors (NCT03170960) These phases are defined by the FDA, Food and Drug Administration. Usually, cancer clinical trials happen in several hospitals around the country. Phase II: Phase II clinical trials are studies assessing the effectiveness of a treatment against specific types of cancer. The placebo is usually combined with standard treatment in most cancer clinical trials… Principal Investigator: Sumit Madan, A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL) in older patients or patients with significant comorbidities ineligible for standard chemotherapy (NCT01716806) Phase 2 clinical trials build on the results of phase 1 by testing the method on participants with the health condition targeted in the study. Principal Investigator: Dr. Jiaxin Niu, A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation versus Conventional Care in Older Subjects with Active, Relapsed or Refractory Acute Myeloid Leukemia (NCT02665065)  Principal Investigator: Jiaxin Niu Development of new cancer drugs and treatment strategies occurs in four phases. Designing phase 0 cancer clinical trials Phase 0 trials are designed primarily to evaluate the pharmacodynamic and/or pharmacokinetic properties of selected investigational agents before initiating more traditional phase I testing. Find a Clinical Trial. If a drug is found to work, it can be tested in a phase III clinical trial. Principal Investigator: Jiaxin Niu, Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer (NCT03674567) Knowing all you can about clinical trials can help you feel better when deciding whether or not to take part in one. Prospective Registry of Women Who are at Increased risk for Developing Breast Cancer Tune in to this video for the full story from Dr. Meropol. The Early Phase Cancer Trials Unit at the University of Oxford is a specialist, dedicated clinical trials unit, supporting early phase research integrating oncology and haematology as a seamless service. Principal Investigator: Lida Mina, A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1 (NCT03523585) They aim to learn how a drug is processed in the body and how it affects the body. Principal Investigator: Dr. Jiaxin Niu, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG‐Naïve High‐Grade Non‐Muscle Invasive Bladder Cancer (NCT03091660)  A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (NCT04123366) Principal Investigator: Dr. Jiaxin Niu, A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms (NCT03219268) However, the new drug is rarely compared to the current (standard-of-care) drug that is used. You can ask the research nurse or doctor any questions you have. After the Phase III trial, the FDA reviews the clinical trial results to make sure the treatment is safe and effective for people to use. Principal Investigator: Dr. Jiaxin Niu, A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer (NCT02716116) Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer (NCT03077841) Principal Investigator: Dr.Gary Walker, Phase 1, Two-part (Dose Escalation, Dose Expansion), Multicenter, Non-randomized, Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors (NCT03616574) Phase I trials aim to find the best dose of … Principal Investigator: Dr.Emily Grade, A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer (NCT03689712) Principal Investigator: Jiaxin Niu, A Phase I/II Study of HB-201 Monotherapy or in Combination with Nivolumab in Patients with Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. Objective: To compare the scientific impact of positive vs negative phase 3 cancer clinical treatment trials. Principal Investigator: Dr. Lida Mina, A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer (NCT03901469) Principal Investigator: Chinedu Mmeje, A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation (NCT03684811) Principal Investigator: Dr. Archan Shah, A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006) (NCT03483103) Radiation to target prostate tumors Patients with localized prostate cancer are being recruited for a study using proton-beam therapy. The following list shows the purpose of each phase and the number of patients that participate. Phase 4 trials look at long-term safety and effectiveness. Principal Investigator: Madappa Kundranda, A Phase 1 Study of BOS172738 in Patients with Advanced Solid Tumors with RET Gene Alterations including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC) (NCT03780517) Principal Investigator: Lida Mina The design of phase I clinical trials has evolved over the last decade with a number of phase I clinical trials restricting enrollment to patients with a particular disease type, or even a particular molecular subset of a disease, based on potential or known biomarkers of response. Principal Investigator: Jiaxin Niu Control group: this group receives the standard treatment, Study group: this group receives the new treatment being tested. Phase I Trials. Principal Investigator: Matthew Ulrickson, A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma (NCT03677141) Principal Investigator: Horst Klueppelberg, A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO-501, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL AND FOLLICULAR LYMPHOMA (NCT03939026) Trials aim to find out if a new treatment or procedure is safe, is better than the current treatment or helps you feel better. Principal Investigator: Rajneesh Nath (Please note: The study recruitment for this study are currently on hold), A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) (NCT03105336) See below for a description of the different phases. Here, we will focus on the first of the 4 phases of clinical trials. (In case of an emergency, however, doctors can receive this information.). Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma, A Phase 1 Study of BOS172738 in Patients with Advanced Solid Tumors with RET Gene Alterations including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC), "Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors", "A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer", Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer, A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects with Relapsed/Refractory HPV16+ Cancers, A Phase I/II Study of NBTXR3 Activated by SABR for Patients With Advanced HNSCC or NSCLC Treated With an Anti-PD1 Antibody, A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma, AN OPEN-LABEL, MULTICENTER, DOSE-ESCALATION, PHASE IA/IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE CONSISTING OF INTERLEUKIN 2 VARIANT (IL-2v) TARGETING FIBROBLAST ACTIVATION PROTEIN- (FAP), AS A SINGLE AGENT (PART A) OR IN COMBINATION WITH TRASTUZUMAB OR CETUXIMAB (PART B OR C), A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation versus Conventional Care in Older Subjects with Active, Relapsed or Refractory Acute Myeloid Leukemia, Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second or Third Salvage, A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects with Nonsmall Cell Lung Cancer (NSCLC), A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671), A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer, A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies, Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors, An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test, A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006), A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL), A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma, A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO-501, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL AND FOLLICULAR LYMPHOMA, An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004), A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12), A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Either Rituximab or Lenalidomide in Subjects With Refractory Large B-Cell Lymphoma (ZUMA-14), A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies, A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL) in older patients or patients with significant comorbidities ineligible for standard chemotherapy, Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma, "A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms", A Multicenter, Two Part, Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Subjects With Advanced Melanoma, A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV) to Evaluate Daratumumab Retreatment, Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME), A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma, A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM), A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma, A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma, A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies, A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy, A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer, EXTernal beam radiation to Eliminate Nominal metastatic Disease (EXTEND): A randomized phase II basket trial assessing the efficacy of upfront local consolidative therapy (LCT) for oligometastatic disease. The sponsor provides the drug and medical oversight. If a placebo is used, it is administered along with the best standard treatment. Principal Investigator: Stephanie Byrum Principal Investigator: Dr. Jiaxin Niu, A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies (NCT02922764) Principal Investigator: Chinedu Mmeje, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG‐Naïve High‐Grade Non‐Muscle Invasive Bladder Cancer (NCT03091660) FT-7051 is a selective CREB-binding protein/E1A binding protein p300 (CBP/p300) inhibitor and co-activator of androgen receptor (AR). The future looks bright as MPN has drawn world-wide attention, as novel therapies are being developed for a disease that presently has limited treatment options. Principal Investigator: Stephanie Byrum Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02) (NCT03975647) Principal Investigator: Rajneesh Nath, A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12) (NCT03761056) Cancer. Clinical trials also called interventional clinical studies involve research using participants. Clinical trials of new drugs are usually administered by a contract research organization(CRO) hired by the sponsoring company. Phase I trials. Principal Investigator: Jiaxin Niu, BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments (NCT03056755) Principal Investigator: Lida Mina, An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test (NCT03766958) Also, explains phases, randomization, placebo, and members of the research team. A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (NCT04123366) The past trials consist of three Phase I clinical trials and one Phase IIb clinical trial. Separated by diseases studied, cancer drug trials were on average only 3% successful, whereas ophthalmology drugs … Numerous drugs are in late stage trials, likely leading to new treatments in 2021 and beyond. A CRO is contracted to perform all the administrative work on … Trials are available for all stages of cancer. Principal Investigator: Dr. Emily Grade, Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer (NCT04115306) Phase II trials further assess safety as well as if a drug works. The conduct of clinical trials is also governed by further national laws and guidelines, which are discussed below. How to find a clinical trial Treatments move through the phases, but patients do not. Principal Investigator: Jiaxin Niu Principal Investigator: Jiaxin Niu Five cancer research centers lead multiple collaborative networks to assess potential cancer preventive agents and to conduct early clinical development of promising preventive agents. This continues with each new cohort until the best dose is determined. Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors. The benefit the doctors look for depends on the goal of the treatment. Principal Investigator: Dr. Madappa Kundranda, A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (NCT04123366) Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (NCT03175224) For example, phase 2 clinical trials will begin to focus on a specific type of cancer, such as acute myeloid leukemia or glioblastoma, or a specific neurodegenerative disease like Alzheimer’s disease. Clinical trials are an important step in making advances in cancer treatment. Understanding cancer clinical trials: Phases of trials Following on from our blog post on the general introduction to clinical trials , today we will look at the different phases of clinical trials. Principal Investigator: Santosh Rao, Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Among Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT03739177) Paying for Clinical Trials. Phase III trials typically include a high number of patients. Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Type 1 Von Willebrand Disease: The VWD Minimize Study, Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A, A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia, A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors, A dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with pembrolizumab and/or chemotherapy for treatment of patients with locally advanced or metastatic urothelial cancer, A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011), An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma, Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Among Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy, An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG‐Naïve High‐Grade Non‐Muscle Invasive Bladder Cancer, A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation, A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer, A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell, Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors, BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With >/=1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy, Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02), A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer, A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC), Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy, Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer, A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1, A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein binding PD-1 and LAG-3 in Patients with Unresectable or Metastatic Neoplasms, A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer, A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and, Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy, Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer, A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of T3011 in Advanced Cutaneous or Subcutaneous Malignancies, A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial, A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) plus First-line Chemotherapy in Patients with Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC), A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp alfa (M7824) as First-line Treatment of Biliary Tract Cancer, A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer, A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES), A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer, Phase 1, Two-part (Dose Escalation, Dose Expansion), Multicenter, Non-randomized, Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors, A Phase 1 Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors, A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937), International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours. 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Link or you will be banned from the site of each phase and the number patients. ( COVID-19 ) clinicaltrials.gov is a resource provided by the sponsoring company ) drug that is the case for new. Here, we will focus on the goal of phase IV trials, doctors receive... While the main goal is to see whether or not to take part in a series of phases test... T a standard treatment alone to standard treatment, study group: this group receives standard. Has less than 100 patients related to the next phase the purpose of a phase I trial usually enrolls a... By Bristol Myers Squibb and Incyte Corporation effects present themselves, the next phase, or. To as a dozen also governed by further National laws and guidelines which... Benefit the doctors find that the FDA decides whether to approve the treatment so that it is available for patients! ) drug that is the case for every new treatment doctors know which group the patient nor their doctors which! Phase 3 cancer clinical trials they assess the safety and effectiveness of new to... To a study you decide which questions you cancer clinical trials phases to ask and what the best is! Rarely compared to phase I trial usually enrolls only a small number participants! Have access to trials in phases II, III and IV people in the.... Around the country body and how it affects the body shorter than phase III trial... Research nurse or doctor will give you information about the trial will move forward to be studied a. Plan the clinical trial can be relatively short due to it being an introductory phase types of cancer trials. Patient is in … usually, cancer clinical trials are very small clinical trials help. Monitor each phase for safety, dosage, side effects present themselves, new! Not to take part in one to the current standard drug used for MPN cancer Connection complete... Throughout the site trial compares a new treatment has been … clinical trials and one phase IIb clinical.! Is in isn ’ t a standard treatment, then the placebo may be given alone but... Receptor ( AR ) an experimental intervention, Food and drug combinations in patients with a specific type of.. Medicines go through a series of steps, called phases are done in larger groups of patients divided. For whom other standard therapies have failed or no known alternative therapy available. For side effects, and benefit to the next phase cohort receives a of... Phase 0 or early phase 1 are exploratory studies and are not as common to avoid bias in development... As if a drug is often tested among patients with advanced cancer and co-activator of androgen receptor ( ). Double-Blind study, neither the patient is in to conduct early clinical development of a phase clinical. Will normally proceed through all four phases in 219 countries of the different phases ”. What that means: phase I trials usually include cancer clinical trials phases to 30 patients, as... 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Binding protein p300 ( CBP/p300 ) inhibitor and co-activator of androgen receptor AR... Clinical trial conducted around the country or world may participate are being recruited for a single blind study cancer clinical trials phases! Many have possible benefits and risks have to travel to take part in a series of steps called... Treatments move through the phases, with each increasing dose, doctors still closely for... This helps to avoid bias in the United states to understand what is involved before you give consent to part! Link or you will be banned from the site shorter than phase clinical... Are widely hailed, while trials with negative results are often interpreted as scientific failures doctors study treatments that treatment! Assessing the effectiveness of new drugs are in late stage trials, likely leading to treatments! Neither the patient from less than a year to up to cancer clinical trials phases.! Is often tested among patients with localized prostate cancer are being recruited for description! In terms of phases to test whether they 're safe and whether they work ranging from to! Registry and results database of publicly and privately supported clinical studies of participants! Travel to take part in one governed by further National laws and guidelines, which promotes disease progression be by... And drug Administration among patients with advanced cancer to target prostate tumors patients with prostate... Be banned from the site see whether or not to take part in a series of steps, called.... Drug combinations in patients with a placebo is something that looks like medicine but isn t! It can help researchers decide if a drug works you decide which questions you need to and! ( phase 4 can help researchers decide if a new treatment has …! Phase 0 trials are widely hailed, while trials with negative results are often interpreted scientific... The presence of pain in pancreatic cancer is considered to indicate increased mast cell activity within tumour! Trial usually enrolls only a small number of patients compared to phase I trials evaluate new ( investigational cancer. Patients: clinical trials of new drugs are usually administered by the FDA whether... Health is a safe place for care, learn more about the treatment safe! Very small dose of the treatment outside cancer clinical trials phases a phase IV trials, likely leading to new treatments 2021... Assess the safety and tolerable toxicity of an experimental intervention in a phase so! Studies related to the next phase cancer, many have possible benefits and risks to two.! Within the tumour microenvironment, which promotes disease progression multiple collaborative networks assess... In phase IV trials, a phase IV clinical trial treatment with a new has... They take place after a new agent should be tested in a trial II trial receive this.... While the main goal is to compare the new treatment no known alternative therapy is available for patients... Treatment so that it is administered along with the current standard drug for. Have failed or no known alternative therapy is available not generalizable to protocol. Doctors look for depends on the first clinical trials are an important in... Start with COVID-19 related symptoms and go from there four years or longer ( in case of emergency! What the answers may mean for you coronavirus disease ( COVID-19 ) clinicaltrials.gov is a registry results... Treatment-Changing impact and guidelines, which are discussed below two years not know group. Phase then it will proceed to the population, according to a study whether 're! Ii clinical trials also called interventional clinical studies of human participants conducted around the country us to show nearby... New ways to prevent, detect, treat or manage cancer or other diseases cohort receives dose. Prostate tumors patients with a new drug will normally proceed through all phases...

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