Clinical Trials


Clinical Trials

A clinical trial is a research study that involves volunteers to test new drugs, treatments and diagnostic tools to help doctors better understand how to diagnose, treat and prevent diseases or conditions. Clinical trials are vital in studying all aspects of medicine with the goal of helping patients live longer, healthier lives. In the United States, the Food and Drug Administration (FDA) requires all new drugs and other treatments to be tested in clinical trials before being approved. Clinical trials show us what works in medicine and healthcare. They are the best way to learn what works best in treating diseases like cancer. Patients who choose to participate in a trial at Millennium Physicians, receive most advanced cancer treatment available, sometimes years before it is offered to the public.

Types of Clinical Trials

Cancer Treatment Trials

Tests new drugs or new combination of drugs. These trials also test new approaches to surgery or giving radiation therapy.

Cancer Prevention Trials

Focus on the use of different medications or change in diet and exercise to determine if the risk of developing cancer decreases or stop it from recurring.

Diagnostic Trials

They find new ways to understand a particular disease or condition.

Screening Trials

Test the best way to detect cancer earlier.

Quality of Life Trials

Cancer can affect people’s health for years, so doctors explore ways to better manage and improve comfort for people who are living with cancer through supportive care trials. Doctors are always looking for ways to make people with cancer feel better.

Participate in a Clinical Trial

The best way to find a clinical trial is to first speak with your doctor and ask about trials that may be appropriate for your cancer type and stage. We have a Research Team here at Millennium Physicians, offering clinical trials that are available to our patients with cancer. If your doctor recommended a clinical trial that you are eligible to participate in and have additional questions, please feel free to contact our research staff for further assistance. They are always happy to explain details of a particular study including the trial’s purpose, how long it will take, what to expect, all potential risks and benefits and information on the privacy of your medical records.

Every clinical trial has its own protocol that determines the eligibility criteria needed in order to participate in that study. Following eligibility criteria helps the doctor and clinical trial research team keep you safe, makes sure the trial treatment is right for you and ensures that researchers learn the information they need. No treatment or procedure, even one already in common use, is entirely without risk. But ask yourself, do the benefits of the new treatment outweigh the possible risks?

It is important to share information about your health with the research team during and after the treatment. They are interested in all the details of your health during the clinical trial. Our highly experienced and compassionate physicians and staff focus on patient safety and care.

Phases of Clinical Trials

On average, a new cancer drug has been studied for at least 6 years before it even makes it to clinical trials. Phases are the stages a clinical trial must go through before they are released to the general public. Every new treatment is tested in 3 or more phases of clinical trials to determine drug dose, safety and effectiveness. The main phases are Phase I, Phase II and Phase III. The different phases give doctors different information about the treatment being studied.

A person does not go through each phase of a clinical trial. You can join a clinical trial at any phase. You can always leave a clinical trial at any time for any reason. If you decide to leave the study, talk to your doctor first to go over the affects it may have on your health and what other treatment options are available for you. 

The most critical phase due to the development of a new drug or treatment. The main goal is to determine how well it works against a particular type of cancer, along with safety, best uses, dosage, frequency of dosage and identify side effects.

Trials study the safety and effectiveness of the treatment and evaluate how it affects the human body. This phase usually focuses on a similar type of cancer amongst patients.

Includes physicians and other investigators to conclude the effectiveness of the new drugs or treatment by comparing new drugs or treatment with the current available treatments. Researchers are trying to see which approach is safer and more effective. In most cases, studies move into Phase III testing only after they have shown promise in Phase I and Phase II. After a treatment passes Phase III, it is submitted for approval by the FDA and once approved; it is made available for the general public.

After the FDA approves a treatment, it may be studied further to examine the safety and effectiveness of a treatment over a long period of time and among a wider patient population. Phase IV trials evaluate the side effects, risks and benefits of a drug or treatment.

Before you decide whether a clinical trial is right for you, make sure you know the facts. Clinical trials offer a lot of hope for many people with cancer. Nearly all of the cancer-fighting drugs and treatments currently available to patients exist because they were thoroughly tested in clinical trials. The best way to ensure you are making the right choice, is taking the time to get as much information as you need to help make that decision. 

Below is a list of available clinical trials and cancer research opportunities through Millennium Physicians. Please talk with your doctor to discuss the treatment options available to you and their likely impact on your disease and quality of life. 

Available Trials

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

  • Condition or Disease: Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
  • Description: This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, inoperable, locally advanced or MBC who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks.
  • Phase: II
  • Study Drug: Venetoclax + Fulvestrant
  • Sponsor: Hoffmann-La Roche

See eligibility criteria and more information about this study


 

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

  • Condition or Disease: Breast Cancer
  • Description: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
  • Phase: III
  • Study Drug: Trastuzumab deruxtecan (DS-8201a) + Ado-trastuzumab emtansine (T-DM1)
  • Sponsor: Daiichi Sankyo, Inc.

See eligibility criteria and more information about this study


 

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

  • Condition or Disease: Breast Cancer
  • Description: QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib (Kisqali® Prescribing Information, Investigator Brochure). The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

    The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

    Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) – Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) – Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).

  • Phase: II
  • Study Drug: Ribociclib
  • Sponsor: Novartis Pharmaceuticals

See eligibility criteria and more information about this study


A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC

  • Condition or Disease: Triple Negative Breast Neoplasms
  • Description: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
  • Phase: III
  • Study Drug: Capivasertib + Paclitaxel vs Paclitaxel
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

  • Condition or Disease: Colorectal Cancer
  • Description: A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
  • Phase: II
  • Study Drug: FOLFIRI + VEGF1/2
  • Sponsor: AbbVie

See eligibility criteria and more information about this study

 


 

A Study of BGB-A317 Versus Chemotherapy as Second Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma

  • Condition or Disease: Esophageal Squamous Cell Carcinoma (ESCC)
  • Description: The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line treatment in patients with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy
  • Phase: III
  • Study Drug: BGB-A317 versus Chemotherapy
  • Sponsor: BeiGene

See eligibility criteria and more information about this study

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma (HIMALAYA)

  • Condition or Disease: Hepatocellular Carcinoma
  • Description: This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.
  • Phase: III
  • Study Drug: Durvalumab + Tremelimumab vs. Sorafenib
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 


 

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

  • Condition or Disease:Hepatocellular Carcinoma
  • Description: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
  • Phase: III
  • Study Drug: Durvalumab + TACE/Avastin​
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)

  • Condition or Disease: Non-Small Cell Lung Cancer (NSCLC)
  • Description: This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
  • Phase: II
  • Study Drug: Durvalumab +/- Olaparib
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 


 

A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: To compare the efficacy of AM0010 in combination with nivolumab versus nivolumab alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate.
  • Phase: II
  • Study Drug: Pembrolizumab
  • Sponsor: Eli Lilly and Company

See eligibility criteria and more information about this study

 


 

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: To compare the efficacy of AM0010 in combination with pembrolizumab versus pembrolizumab alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate
  • Phase: II
  • Study Drug: Nivolumab
  • Sponsor: Eli Lilly and Company

See eligibility criteria and more information about this study

 

 


 

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON)

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
  • Phase: III
  • Study Drug: Durvalumab + Tremelimumab + Chemo
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 


 

Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC (ATALANTE 1)

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.
  • Phase: III
  • Study Drug: OSE2101 vs Docetaxel or Pemetrexed
  • Sponsor: OSE Immunotherapeutics

See eligibility criteria and more information about this study

 


 

A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled.
  • Phase: II
  • Study Drug: Encorafenib + Binimetinib
  • Sponsor: Array BioPharma

See eligibility criteria and more information about this study

 


 

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

  • Condition or Disease: Non-Small Cell Lung Cancer
  • Description: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
  • Phase: III
  • Study Drug: Durvalumab Neo/Adjuvant
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 


A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER)

  • Condition or Disease: Non-Small Cell Lung Cancer
  • Description: This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors.
  • Phase: I
  • Study Drug: Durvalumab + XRT
  • Sponsor: AstraZeneca

See eligibility criteria and more information about this study

 


​​

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

  • Condition or Disease: Non-Small Cell Lung Cancer
  • Description: The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab’s safety and effectiveness in treating resectable NSCLC.

    This study has multiple primary endpoints.

    The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020.

    The completion date for all primary outcome measures is expected May 2023

  • Phase: III
  • Study Drug: Neoadjuvant Opdivo/Yervoy vs Platinum Doublet
  • Sponsor: Bristol-Myers Squibb

See eligibility criteria and more information about this study

 


​​​

A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy in Combination With Checkpoint Inhibitor Therapy

  • Condition or Disease: Non-Small Cell Lung Cancer
  • Description: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy in combination with checkpoint inhibitor therapy.
  • Phase: III
  • Study Drug: Sitravatinib (TAM-TKI)
  • Sponsor: Mirati Therapeutics Inc.

See eligibility criteria and more information about this study

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. (MAGNIFY)

  • Condition or Disease: Non-Hodgkin’s Lymphoma
  • Description: Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
  • Phase: III
  • Study Drug: Revlimid + Rituxan (R2)
  • Sponsor: Celgene

See eligibility criteria and more information about this study

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

  • Condition or Disease: Multiple Myeloma
  • Description: The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
  • Phase: II
  • Study Drug: Daratumumab SQ
  • Sponsor: Janssen Research & Development, LLC

See eligibility criteria and more information about this study

 


 

An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma (MM) Previously Receiving a Bortezomib-based Induction Regimen (US MM-6)

  • Condition or Disease: Multiple Myeloma
  • Description: The purpose of this study is to determine the progression-free survival (PFS) at 2 years for MM participants previously receiving a bortezomib-based induction regimen to IRD
  • Phase: IV
  • Study Drug: Ninlaro
  • Sponsor: Takeda

See eligibility criteria and more information about this study

Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

  • Condition or Disease: Prostate Cancer
  • Description: The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.
  • Phase: III
  • Study Drug: Radium-223 and Docetaxel vs. Docetaxel
  • Sponsor: Memorial Sloan Kettering Cancer Center

See eligibility criteria and more information about this study

Contact

Members of our clinical trials study team can tell you more about the types of research taking place at Millennium Physicians locations. If you have questions about a specific study, please contact our staff. If you would like assistance searching for clinical studies that match your interest, please contact your doctor. 

LOCATIONS

North Houston

17323 Red Oak Drive

Houston, TX 77090

Kingwood

22710 Professional Drive Ste. 100

Kingwood, TX 77339

Shenandoah

18488 I-45 South

Shenandoah, TX 77384

The Woodlands

9319 Pinecroft Drive Ste. 100

The Woodlands, TX 77380

Phone

877-870-2640