Cancer Clinical Trials

At MD Anderson Cancer Center at Cooper, our team of physicians, nurses and other cancer specialists work together bring the most innovative clinical trials to our patients. 

Through these clinical trials, patients have access to treatment options that may not be available elsewhere.  

If you or your family member is interested in being part of a clinical trial, please email ResearchCancer@cooperhealth.edu or review the list below of the current clinical trials offered at MD Anderson at Cooper. 

Breast Cancer Clinical Trials

A Phase III, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting

Principal Investigator: Kamel Abou Hussein, MD

Short Title: DESTINY 6

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

National Clinical Trial Identified Number: NCT04494425

A Phase III, Randomized, Open-Label,Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, Her2-Negative Early
Breast Cancer

Principal Investigator: Robert A Somer, MD

Short Title: GO42784 lidERA

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

National Clinical Trial Identified Number: NCT04961996

A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer

Principal Investigator: Stuti Ahlawat, MD

Short Title: SAPHIRe

To compare the risk of developing lymphedema, defined as a 10% difference in volume between the affected and unaffected arm, within 24 months of RNI between patients assigned to short versus standard RNI.

National Clinical Trial Identified Number: NCT02912312

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Her2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Principal Investigator: Robert A Somer, MD

Short Title: WO42633/Astefania

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

National Clinical Trial Identified Number: NCT04873362

Using FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer

Principal Investigator: Kamel Abou Hussein, MD

Short Title: FEATURE

This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.

National Clinical Trial Identified Number: NCT04316117

Potential Impact of the Covid-19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact on Out of Pocket Costs, Lost Wages and Economic Strain

Principal Investigator: Steven C. Bonawitz, MD, FACS

Short Title: Financial Toxicity

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). 

National Clinical Trial Identified Number: NCT04169542

Geographic Variation of Microbiome and Correlation with Treatment Response among Patients with Breast Cancer

Principal Investigator: Robert A. Somer, MD

Short Title: Microbiome

This study aims to characterize microbiome of breast cancer patients and correlate it to response to therapy for patients who are newly diagnosed breast cancer planning neoadjuvant chemotherapy

National Clinical Trial Identified Number: N/A

High-Risk Breast Cancer Registry

Principal Investigator: Jenia Jenab-Wolcott, MD, PhD

The purpose of this registry is to collect data on patients at high risk for breast cancer or who have been diagnosed with breast cancer at MD Anderson Cancer Center at Cooper. The importance of the registry is to create a single institution database of individuals (men or women) at increased risk for developing breast cancer or individuals who have had a prior history of breast cancer. The data provided by a site-specific cancer registry can play a significant role in future planning of cancer control programs, in screening and early detection, and in contributing to improved breast cancer care.

National Clinical Trial Identified Number: N/A

Gastrointestinal Cancer Clinical Trials

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer

Principal Investigator: Kinjal Kiran Dargan, MD

Short Name: GI005/COBRA

This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.

National Clinical Trial Identified Number: NCT04068103

High-Risk Colorectal Cancer Registry Program

Principal Investigator: Steven McClane, MD

The purpose of this registry is to create and maintain a prospective and retrospective database of patients with early-onset colorectal cancer or who are at increased risk for colorectal cancer based on germline gene mutation status, personal history of cancer, and/or family history of cancer.

National Clinical Trial Identified Number: N/A

Minimal Residual Disease Assessment in Colorectal Cancer

Principal Investigator: Jamin Morrison, MD

Short Name: MiRDA

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

National Clinical Trial Identified Number: NCT04739072

A Randomized Phase II Double-Blind Study of Olaparib versus Placebo Following Curative Intent Therapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

Principal Investigator: Jamin Morrison, MD

Short Name: APOLLO

This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

National Clinical Trial Identified Number: NCT04858334

Genitourinary Cancer Clinical Trials

Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (Innovate*)*INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy

Principal Investigator: Gary Eastwick, MD

Short Title: GU008

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. 

National Clinical Trial Identified Number: NCT04134260

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*) *Prostate RNA Expression/Decipher to Individualize Concurrent Therapy with Radiation

Principal Investigator: Gary Eastwick, MD

Short Title: GU009

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score.

National Clinical Trial Identified Number: NCT04513717

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (Guidance)

Principal Investigator: Gary Eastwick, MD

Short Title: GU010

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy).

National Clinical Trial Identified Number: NCT05050084

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence

Principal Investigator: Gary Eastwick, MD

Short Title: INDICATE

This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation).

National Clinical Trial Identified Number: NCT04423211

Gynecologic Cancer Clinical Trials

A Phase Ib/II, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 in patients with Solid Tumors Likely to Express NaPi2b

Principal Investigator: David Warshal, MD

Short Title: GOG 3048/UPLIFT

This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) will be administered as an intravenous infusion once every four weeks. The study consists of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The DES segment studied small groups of patients who received increased doses

National Clinical Trial Identified Number: NCT03319628

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVa, Stage IVb or Recurrent Endometrial Cancer 

Principal Investigator: David Warshal, MD

Short Title: GY018

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

National Clinical Trial Identified Number: NCT03914612

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum 

Principal Investigator: David Warshal, MD

Short Title: GY019

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

National Clinical Trial Identified Number: NCT04095364

Phase II Study of the Levonorgestrel Intrauterine Device Alone or in Combination with the mTORC1 Inhibitor, Everolimus, for the Treatment of Complex Atypical Hyperplasia and Stage Ia Grade 1 Endometrial Cancer

Principal Investigator: David Warshal, MD

Short Title:  LEVER

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with Everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer.

National Clinical Trial Identified Number: NCT02397083

An Open-Label Randomized Active-Controlled Phase II Clinical Study to Assess the Efficacy and Safety of Afuresertib Plus Paclitaxel Versus Paclitaxel in Patients with Platinum-Resistant Ovarian Cancer

Principal Investigator: David Warshal, MD

Short Title: LAEKNA

Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression.

National Clinical Trial Identified Number: NCT04374630

Head and Neck Cancer Clinical Trials

Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaption I Human Papilloma Virus Positive Oropharyngeal Cancer

Principal Investigator: Megan Mezera, MD

Short Title: MR Linac

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.

National Clinical Trial Identified Number: NCT03224000

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

Principal Investigator: Megan Mezera, MD

Short Title: Oral 3D Stent

The primary objective of this randomized trial is to evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

National Clinical Trial Identified Number: NCT04870762

Hematology Clinical Trials

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study

Principal Investigator: Tulin Budak-Alpdogan, MD

Short Title: EVOLVE

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

National Clinical Trial Identified Number: NCT04269902

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator: Sushil Ghimire, MD

Short Title: DETER-SMM

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

National Clinical Trial Identified Number: NCT03937635

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Principal Investigator: Tulin Budak-Alpdogan, MD

Short Title: GCT3013-05

The drug that will be investigated in the study is an antibody, epcoritamab, also known as GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT.

National Clinical Trial Identified Number: NCT04628494

Phase III Study of Daratumumab + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

Principal Investigator: Tulin Budak-Alpdogan, MD

Short Title: DRAMMATIC

This clinical trial offers treatment to patients with multiple myeloma who have undergone ASCT, a type of transplant that uses a patient's own stem cells (cells in the bone marrow that produce new blood cells) to replace those normal cells that are damaged by the high dose chemotherapy treatment that is given to kill cancer cells. Because there is a possibility of cancer returning even after ASCT, patients typically receive maintenance treatment, with the goal of preventing or delaying the return of cancer. In this clinical trial, one group of patients will be randomly assigned to receiving the standard maintenance treatment for multiple myeloma — an immunomodulatory drug called lenalidomide - which works by stimulating cells in the immune system, decreasing the blood supply to tumors, and inhibiting the growth of cancer cells.

National Clinical Trial Identified Number: NCT04071457

Lung Cancer Clinical Trials

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer 

Principal Investigator: Polina Khrizman, MD

Short Title: PACIFIC-4

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with standard of care SBRT versus placebo with standard of care SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

National Clinical Trial Identified Number: NCT03833154

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC 

Principal Investigator: Polina Khrizman, MD

Short Title: S1914

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

National Clinical Trial Identified Number: NCT04214262

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (Lung)

Principal Investigator: Young Hong, MD

Short Title: IOV-LUN-202

This study is to evaluate the efficacy of LN-145 in patients with metastatic NSCLC without an actionable driver mutation who have disease progression on or following a single line of approved systemic therapy consisting of combined immune checkpoint inhibitor(s) (CPI[s]) + chemotherapy ± bevacizumab.

National Clinical Trial Identified Number: NCT03645928

Melanoma Clinical Trials

The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma 

Principal Investigator: Gary Eastwick, MD

Short Title: MelPORT

This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.

National Clinical Trial Identified Number: NCT04594187

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (Melanoma)

Principal Investigator: Young Hong, MD

Short Title: IOV-COM-202

This study is to evaluate the efficacy of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients.

National Clinical Trial Identified Number: NCT03645928

Multi-Disease Site Clinical Trials

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors Melanoma and Lung

Principal Investigator: Young Hong, MD

Short Title: IOV-COM-202

This study is to evaluate the efficacy of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients.

National Clinical Trial Identified Number: NCT03645928

A Pre-Consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center: Protocol for a Randomized Control Trial

Principal Investigator: Brian Roberts, MD

Short Title: Compassion

The aim of this randomized control trial is to test if watching a brief video containing compassionate statements from an oncologist, compared to watching a standard introduction video, prior to an initial oncology consultation will reduce the degree of anxiety among patients referred to a cancer center.

National Clinical Trial Identified Number: NCT04503681

Orthopedic Oncology Clinical Trials

Genomic Analysis of Bone Sarcomas 

Principal Investigator: Tae Kim, MD

Short Title: PA14-1067

The objectives of the study are to better understand the role of genomic alterations in bone sarcoma patients whose cancers have either progressed on therapy, after a period of response, or were refractory to initial "first-line" treatment.

National Clinical Trial Identified Number: N/A

Contact Us

For more information about cancer clinical trials at MD Anderson at Cooper, please email ResearchCancer@cooperhealth.edu. Thank you.