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

Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer

  • Condition or Disease:  Advanced Melanoma / Triple-Negative Breast Cancer
  • Description: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC
  • Phase: II
  • Study Drug: Imprime PGG and Keytruda
  • Sponsor: Biothera

See eligibility criteria and more information about this study

Modufolin® in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

  • Condition or Disease: Colorectal Neoplasm
  • Description: The purpose is to characterise the tolerability of Arolixtixorin versus Leucovorin in combination with 5-FU, Oxaliplatin and Avastin (aka Bevacizumab)
  • Phase: I and II
  • Study Drug: Arfolitixorin
  • Sponsor: Isofol Medical AB

See eligibility criteria and more information about this study


A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

  • Condition or Disease: Colorectal Cancer
  • Description: This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (Prior Vectibix excluded)
  • Phase: III
  • Study Drug: FOLFIRI + Napabucasin
  • Sponsor: Boston Biomedical, Inc

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

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

  • Condition or Disease: Multiple Myeloma
  • Description: The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for Group 3. There is an equal chance to be assigned to either Group 1 or Group 2. Group 3 is no longer open for enrollment.
  • Phase: III
  • Study Drug: Opdivo/Emplicity/Pomalidomide/Dexamethasone
  • Sponsor: Bristol-Meyers Squibb

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

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 Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (B-MIND)

  • Condition or Disease: Diffuse Large B-cell Lymphoma
  • Description: The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL
  • Phase: II and III
  • Study Drug: MOR208 + Treanda
  • Sponsor: MorphoSys AG

See eligibility criteria and more information about this stud

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung

    This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached September 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


Study of AM0010 With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 1)

  • 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: Opdivo +/- Peg IL-10
  • Sponsor: OSE Immunotherapeutics

See eligibility criteria and more information about this study

 


Study of AM0010 With Nivolumab Compared to Nivolumab Alone Second-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 2)

  • 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: Keytruda +/- Peg IL-10
  • Sponsor: ARMO BioSciences

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). (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

 


Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

  • Condition or Disease: Non Small Cell Lung Cancer
  • Description: This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.

    The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.

  • Phase: I and II
  • Study Drug: 2nd/3rd Line SCLC with Trilaciclib and Topotecan
  • Sponsor: G1 Therapeutics, Inc.

See eligibility criteria and more information about this stud

 

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


Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

  • Condition or Disease: Squamous Cell Carcinoma of the Head and Neck
  • Description: This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin.
  • Phase: III
  • Study Drug: Opdivo +/- Cisplatin + XRT 
  • Sponsor: Bristol-Myers Squibb

See eligibility criteria and more information about this study


Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

  • Condition or Disease: Head and Neck Cancer
  • Description: The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).
  • Phase: III
  • Study Drug: Opdivo + Epacadostat + Cis/5FU vs EXTREME Regimen
  • Sponsor: Bristol-Myers Squibb

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