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. Phase 0 trials are very small trials that help researchers decide if a new agent should be tested in a phase 1 trial. (In case of an emergency, however, doctors can receive this information.). Principal Investigator: Jiaxin Niu, 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 (NCT03767348) The average length of a Phase IV clinical trial is usually shorter than Phase III so typically fewer than four years. 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. Randomised trials. Knowing all you can about clinical trials can help you feel better when deciding whether or not to take part in one. Phase II trials are done in larger groups of patients compared to Phase I trials. Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During This article is sponsored by Bristol Myers Squibb and Incyte Corporation. Information covering the basics of cancer clinical trials, including what they are, where they take place, and the types of clinical trials. See below for a description of the different phases. ), It depends on the trial. Phase 0 trials are the first clinical trials done among people. Principal Investigator: Lida Mina, An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test (NCT03766958) The NCI launched the CTSU in 1999 to streamline and harmonize support services for phase three Cooperative Group cancer clinical trials funded by the NCI. 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) Cancer. 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) 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) If a new drug is successful in an early phase then it will proceed to the next phase. This guide addresses many basic questions and concerns about clinical trials so that you will be better prepared to discuss this option with your doctor and your family. For a single blind study, patients do not know which group they are in, but their doctor does. Trials aim to find out if a new treatment or procedure is safe, is better than the current treatment or helps you feel better. The phase of the trial depends on the questions that the doctors are trying to answer – such as its risks, safety and effectiveness compared to standard therapy. Principal Investigator: Matthew Ulrickson, "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) Researchers monitor each phase for safety, dosage, side effects, and benefit to the patient. Principal Investigator: Dr. Jiaxin Niu, 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 (NCT03767348) Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors. To understand the landscape of PS restriction, we analyzed a large collection of phase III cancer randomized clinical trials (RCTs). A placebo is an inactive drug or treatment used in a clinical trial. 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) Often, new combinations of drugs are tested. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Principal Investigator: Dr. Anna Likhacheva, Skin Surface Brachytherapy for Non-Melanoma Skin Cancers: Prospective Data Registry and Quality of Life Assessment Explore 364,449 research studies … We identified trial-related factors associated with the use of PS-restrictive eligibility criteria (defined as the inclusion of only patients with ECOG PS ≤1) and analyzed the use of strict PS eligibility criteria over time. Principal Investigator: Santosh Rao, Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Among Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT03739177) University of Wisconsin Carbone Cancer Center is unique in offering Phase I clinical trials as part of a patient's treatment plan since only certain facilities are able to conduct these types of studies. These phases are defined by the FDA, Food and Drug Administration. These trials are less common. Clinical trials of new drugs are usually administered by a contract research organization(CRO) hired by the sponsoring company. They take place after a new treatment has been … Principal Investigator: Lida Mina At first, very few people receive the medicine being studied. 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) These phases are defined by the FDA, Food and Drug Administration. Principal Investigator: Mohammed Khan In Phase IV trials, doctors study treatments that the FDA has already approved. Usually, cancer clinical trials happen in several hospitals around the country. Principal Investigator: Santosh Rao, 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) (NCT03898180) Principal Investigator: Dr. Rajneesh Nath, 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 (NCT02665065) Objective: To compare the scientific impact of positive vs negative phase 3 cancer clinical treatment trials. Phase 0. Phase 1 purpose is to find a safe dose, decide how the new drug should be given by mouth or in a vein and see how the new drug affects the body and fights the cancer. Principal Investigator: Sumit Madan, A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies (NCT03886831) Principal Investigator: Madappa Kundranda, 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 (NCT03750786) Principal Investigator: Lida Mina They then plan the clinical trial to progress in a series of up to four steps called phases. Phase 4 trials look at long-term safety and effectiveness. Several dose-escalation designs based on mathematical modeling of the dose-toxicity relationship have been developed. Principal Investigator: Sumit Madan, A Multicenter, Two Part, Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Subjects With Advanced Melanoma (NCT03084640) Patients are closely watched to see if the drug works. A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer (NCT03983395) If there isn’t a standard treatment, then the placebo may be given alone, but this is uncommon. 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) Patients enrolled in a Phase III clinical trial will be placed into one of the following groups: A computer program will randomly assign patients into groups. Principal Investigator: Rajneesh Nath, A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NCT02343042) and to see whether or not the cancer responds. Clinical trials testing potential medical products are commonly classified into four phases. Researchers monitor each phase for safety, dosage, side effects, and benefit to the patient. Phase II trials further assess safety as well as if a drug works. Principal Investigator: Shakeela Bahadur This continues with each new cohort until the best dose is determined. The benefit the doctors look for depends on the goal of the treatment. 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) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. This phase looks at the long-term safety and effectiveness and takes place after the new drug has been approved by the FDA and is on the market. Many phase 3 clinical trials could have treatment-changing impact. What are the Clinical Trial Phases? Principal Investigator: Dr.Gary Walker, Prospective Data Registry and Quality of Life Assessment of Men Undergoing High Dose Rate Brachytherapy of the Prostate Using Real-Time Ultrasound Planning Principal Investigator: Rajneesh Nath Principal Investigator: Boris Naraev, 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 (NCT03377491) Paying for Clinical Trials. If no severe side effects present themselves, the next cohort will receive a higher dose of the same drug. Principal Investigator: Dr. Madappa Kundranda, Principal Investigator: Dr. Tomislav Dragovich, A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer (NCT02921256) Trials are available for all stages of cancer. Typically, a Phase II trial has less than 100 patients. However, the new drug is rarely compared to the current (standard-of-care) drug that is used. 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, For life-threatening emergencies, find the nearest emergency room, Gastrointestinal Cancer (Pancreatic, Colorectal, Gastric, Liver, Biliary and Neuroendocrine Cancers), Gynecologic Cancer (Cervical and Ovarian Cancers), Myeloproliferative Neoplasm (MPN) or Myelodysplastic Syndrome (MDS). The drug development process will normally proceed through all four phases over many years. 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) The average length of a Phase III clinical trial can vary, ranging from one to four years or longer. A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell (NCT03912831) You can ask the research nurse or doctor any questions you have. Principal Investigator: Dr. Jiaxin Niu, 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 (NCT03912831) Principal Investigator: Dr. Danielle Nance, Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A (NCT03932201) 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 (NCT03912831) The medicines will usually be tested against another treatment called a control. 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. I had thought that there were just three phases but it turns out that there are five, at least when it comes to cancer treatments, with just the middle three getting the most attention. A 2019 review of average success rates of clinical trials at different phases and diseases over the years 2005-15 found a success range of 5-14%. Also, explains phases, randomization, placebo, and members of the research team. 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: Sumit Madan, 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 (NCT04093596) Control group: this group receives the standard treatment, Study group: this group receives the new treatment being tested. Using a placebo allows doctors to compare standard treatment alone to standard treatment with a new drug. The FDA decides whether to approve the treatment so that it is available for all patients. Thus far, the safety and efficacy of the GP2 immunotherapy have been tested in four clinical trials, where 138 patients have received treatment to date. It is important to understand what is involved before you give consent to take part. 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) If a drug is found to work, it can be tested in a phase III clinical trial. A number of different prevention phase II clinical trial designs exist due to the heterogeneity of the disease processes and the inherent difficulties in sampling tissues from different target organs. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. These trials are usually offered to people who have advanced cancer that is no longer responding to treatment or who have no other treatment options. Clinical trials are often referred to in terms of phases. Phase … 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. The number of participants is less than 100. 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: Jiaxin Niu Phase 4 can help researchers learn more about the treatment outside of a clinical trial and are not as common. Recruiting over 150 patient per year, our key remit is the testing of novel therapies, on a bespoke 15 bedded ward incorporating a sample handling laboratory. The past trials consist of three Phase I clinical trials and one Phase IIb clinical trial. It can help you decide which questions you need to ask and what the answers may mean for you. Principal Investigator: Jiaxin Niu Through clinical trials, doctors find new ways to improve treatments and quality of life for people diagnosed with a type of blood cancer Myeloproliferative Neoplasms (MPNs). Setting your location helps us to show you nearby doctors, locations and events throughout the site. Principal Investigator: Jiaxin Niu, Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer (NCT03674567) Breast Center Genetic Testing Research Protocol Universal hereditary cancer panel testing for women with breast cancer Principal Investigator: Fade Mahmoud, 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 (NCT03871829) “The proportion of minorities in the US population is 36.3% and minorities remain burdened with cancer and under-representation in cancer clinical … How to find a clinical trial 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) 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. 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