Clinical trial treatments typically consist of several phases, with each phase focused on a different purpose. Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.
The goal of a Phase I trial is to determine the safety of the new treatment, learn the best way to administer the treatment (orally, intravenously, etc.) and to see whether or not the cancer responds.
Phase I trials usually include 15 to 30 patients, divided into small groups called cohorts. When the first cohort receives a dose of the new drug, doctors may collect blood or urine samples to measure the drug levels.
If no severe side effects present themselves, the next cohort will receive a higher dose of the same drug. This continues with each new cohort until the best dose is determined. With each increasing dose, doctors test each patient to see if he or she is responding to the protocol treatment. If the doctors find that the treatment is safe, then the trial will move forward to be studied in a Phase II trial.
The average length of a Phase I clinical trial can be relatively short due to it being an introductory phase.
Typically, a Phase II trial has less than 100 patients. While the main goal is to see if the treatment works, doctors still closely watch for side effects. If the new treatment works, doctors may go on to study it in a Phase III trial.
The average length of a Phase II clinical trial can range from less than a year to up to two years.
Phase III trials typically include a high number of patients. Hundreds or even thousands of patients around the country or world may participate. Patients enrolled in a Phase III clinical trial will be placed into one of the following groups:
Common questions patients have include:
A computer program will randomly assign patients into groups. This helps to avoid bias in the clinical trial. (Bias happens when human choices affect a study’s results.)
It depends on the trial. For a single blind study, patients do not know which group they are in, but their doctor does. For a double-blind study, neither the patient nor their doctors know which group the patient is in. (In case of an emergency, however, doctors can receive this information.)
A placebo is something that looks like medicine but isn’t. If a placebo is used, it is administered along with the best standard treatment. Using a placebo allows doctors to compare standard treatment alone to standard treatment with a new drug. If there isn’t a standard treatment, then the placebo may be given alone, but this is uncommon.
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. The FDA decides whether to approve the treatment so that it is available for all patients.
The average length of a Phase III clinical trial can vary, ranging from one to four years or longer.
In Phase IV trials, doctors study treatments that the FDA has already approved. The goal of Phase IV trials is to continue studying any side effects of a new treatment.
The average length of a Phase IV clinical trial is usually shorter than Phase III so typically fewer than four years.
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP) (ELEVATE) (NCT04883905)
Principal Investigator: Dr. Danielle Nance
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Prospective, Observational , Multicenter Study of Effectiveness of Efanesoctocog Alfa on Long-term Joint Health in Patients With Hemophilia A (NCT05911763)
Principal Investigator: Dr. Danielle Nance
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Brain Tumor
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study (NCT05580562)
Principal Investigator: Terrence Roberts
Locations: Banner MD Anderson Cancer Center at Banner - University Medical Center Phoenix
Glioblastoma
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer (NCT05256290)
Principal Investigator: Jiaxin Niu
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial (NCT04457596)
Principal Investigator: Hung Khong (AZ), Esther Mondo (NoCo)
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Banner MD Anderson Cancer Center at Banner - University Medical Center Phoenix, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Prospective comparison of MRI versus contrast enhanced mammography prior to surgery in breast cancer patients: a randomized controlled trial (NCT04770714)
Principal Investigator: Michael Morris
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center and Banner MD Anderson Cancer Center at Banner - University Medical Center Phoenix
Inflammatory Breast Cancer (IBC) Registry (NCT00477100)
Principal Investigators: Hung Khong (AZ), Esther Mondo (NoCo)
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Banner MD Anderson Cancer Center at Banner Boswell Medical Center, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) (NCT05629585)
Principal Investigator: Hung Khong
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (NCT03488693)
Principal Investigator: Supriya Jain
Location: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence (NCT05514054)
Principal Investigator: Hung Khong (AZ), Esther Mondo (NoCo)
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy (NCT05646862)
Principal Investigator: Hung Khong
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (NCT05894239)
Principal Investigator: Hung Khong
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Prospective Case Collection Study for New Mammography Technologies (NCT05199701)
Principal Investigator: Bryan Johnston
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer (NCT05508906)
Principal Investigator: Hung Khong
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2) (NCT05654623)
Principal Investigator: Hung Khong
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Thyroid
A Phase 1, Open-label Study of BDTX-4933 in Patients With BRAF and Other Select RAS/MAPK Mutation-Positive Neoplasms (NCT05786924)
Principal Investigator: Jiaxin Niu
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Colorectal Cancer
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer (NCT05609370)
Principal Investigator: Madappa Kundranda
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Prospective Evaluation of Nivolumab in Adjuvant Esophageal Carcinoma/Gastroesophageal Junction Carcinoma: A Non-interventional Study (NCT05780736)
Principal Investigator: Christina Gomez
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1/2, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (NCT05597839)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Solid Tumor
A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors (NCT05712356)
Principal Investigator: Madappa Kundranda
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Colorectal, Pancreatic, Rectal, Esophageal
An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing (NCT04981119)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Pancreatic, Colorectal
A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (NCT05736731)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Pancreatic Ductal Adenocarcinoma (PDAC)
First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (NCT05726864)
Principal Investigator: Madappa Kundranda
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Bladder Cancer
A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) (NCT05538663)
Principal Investigator: Chinedu Mmeje
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2 (NCT04879329)
Principal Investigator: Alex Bowman
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States (NCT06026332)
Principal Investigator: Joseph Mashni
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC) (NCT05024773)
Principal Investigator: Joseph Mashni
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) (NCT05014139)
Principal Investigator: Chinedu Mmeje
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Prostate Cancer
Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*) (NCT04513717)
Principal Investigator: Randall Brenneman
Location: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE) (NCT05050084)
Principal Investigator: Mark Dziemianowicz (CO), Yerko Borghero (AZ)
Location: Banner MD Anderson Cancer Center at McKee Medical Center, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer (NCT03678025)
Principal Investigator: Chinedu Mmeje (AZ), Supriya Jain (NoCo)
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean) (NCT05053152)
Principal Investigator: Mark Dziemianowicz
Locations: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Urothelial
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater) (NCT05911295)
Principal Investigator: Alex Bowman
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Cervical Cancer
Molecular and microbial drivers of cervical cancer progression and response to therapy
Principal Investigator: Gary Walker (AZ), Robin Lacour (CO)
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Endometrial Cancer
A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma (NCT05256225)
Principal Investigator: Robin Lacour
Locations: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
Head and Neck
A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents (NCT04870762)
Principal Investigator: Gary Walker
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Oral Cancer
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer (NCT04333537)
Principal Investigator: Thomas Shellenberger
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Solid Tumor
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 (NCT04180215)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Squamous Cell Carcinoma
Phase I Trial With Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients With Stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) (NCT04533750)
Principal Investigator: Michael Samuels
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Previously Untreated Locally Advanced HNSCC (NCT04651634)
Principal Investigator: Gary Walker
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT06054477)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma (NCT05323253)
Principal Investigator: Michael Samuels
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN) (NCT06064877)
Principal Investigator: Saba Radhi
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1/2, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (NCT05597839)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx (NCT05966194)
Principal Investigator: Gary Walker
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Xerostomia Caused by Radiotherapy
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia (NCT05926765)
Principal Investigator: Gary Walker
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT04067336)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Acute Myeloid Leukemia (AML)
A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer (NCT04243499)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia (NCT06001788)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study Brief Summary (NCT05546580)
Principal Investigator: Rajneesh Nath
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT (NCT05429632)
Principal Investigator: Rajneesh Nath
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1, Open-label Study of BDTX-4933 in Patients With BRAF and Other Select RAS/MAPK Mutation-Positive Neoplasms (NCT05786924)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study (NCT04783168)
Principal Investigator: Elbert Kuo
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Non-Small Cell Lung Cancer
A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (NCT05736731)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and/or HER2 Mutation (NCT05099172)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors (NCT05381909)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer (NCT05256290)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1/2, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (NCT05597839)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NCT06497556)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Small Cell Lung Cancer
MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (NCT04155034)
Principal Investigator: Supriya Jain
Location: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE) (NCT05468489)
Principal Investigator: Lin Hao
Location: Banner MD Anderson Cancer Center at McKee Medical Center and Banner MD Anderson Cancer Center at North Colorado Medical Center
A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma (NCT04989803)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma (NCT04792489)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) (NCT04637763)
Principal Investigator: Rajneesh Nath
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies (NCT05336409)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23) (NCT05605899)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004) (NCT05144841)
Principal Investigator: Sunil Tulpule
Locations: Banner MD Anderson Cancer Center at Banner Gateway Medical Center and Banner MD Anderson Cancer Center at Banner - University Medical Center Phoenix
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies (NCT05544019)
Principal Investigator: Matthew Ulrickson
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Decision Dx-Melanoma Impact on Sentinel Lymph Node Biopsy Decisions and Clinical Outcomes (DECIDE)
Principal Investigator: Mark Gimbel
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma, Melanoma, or Merkel Cell Carcinoma (NCT06014086)
Principal Investigator: Mark Gimbel
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II) (NCT03860883)
Principal Investigator: Mark Gimbel
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma (NCT06425991)
Principal Investigator: Sumit Madan
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION (NCT05317416)
Principal Investigator: Sumit Madan
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A PHASE I OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SAIL66 IN PATIENTS WITH CLDN6-POSITIVE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS (SAL101JG) (NCT05735366)
Principal Investigator: Madappa Kundranda
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors (NCT05989724)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors (NCT05599984)
Principal Investigator: Jiaxin Niu
Location: Banner MD Anderson Cancer Center at Banner Gateway Medical Center
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