Clinical Research
Clinical trials are a way to determine if a new medication or device is safe and effective to treat a specific medical condition. Your participation allows you to try the newest medication for your condition while aiding researchers in the development of new treatment and medical procedures, potentially benefiting you, your family and other patients. The work completed here has resulted in U.S. Food and Drug Administration approval of new treatments for patients.
Bozeman Health Clinical Research
With your collaboration, we provide our sponsors and other clinical research organizations with high-quality, ICH GCP/FDA-compliant research while also providing patients with professional, cutting-edge care to enhance the health and well-being of our community.
Participation in research is a voluntary and personal decision. At Bozeman Health Clinical Research, our top priority is patient safety.
Frequently Asked Questions
What are the clinical trial phases?
Clinical trials are divided by the Food and Drug Administration (FDA) into categories as described below:
Phase I: Clinical studies that are conducted with 20-100 healthy volunteers or people with a specific disease/condition to determine the safety and dosage of a new drug or device, and identify side-effects.
Phase II: Clinical studies that are conducted with several hundred healthy volunteers or people with a specific disease/condition to determine the effectiveness/efficacy of a new drug or device and further study the safety of the product.
Phase III: Clinical studies that are conducted with 300 to several thousand healthy volunteers or people with a specific disease/condition to better confirm the effectiveness of a new drug/device, compare it with standard or similar treatments, and collect information on adverse reactions to allow the product to be used safely.
Phase IV: Clinical studies that are conducted with several thousand healthy volunteers or people with a specific disease/condition after the drug/device is approved by the FDA and made available to the public. Phase IV trials help researchers track the safety of a new drug/device in the general population and provide more information about a drug’s/device’s benefits and optimal use.
References:
- National Institutes of Health – Clinical Research Trials and You: The Basics
- U.S. Food and Drug Administration – Step 3: Clinical Research.
How am I protected while participating in clinical trials?
Each clinical trial is approved to conduct research with human subjects by an Institutional Review Board (IRB), which is a group of at least five members from varying backgrounds (e.g., Medicine, Law, Education, Religion, etc.) with the professional competence necessary to review the risks, benefits, and specific research activities involved in the study. Each IRB must include at least one member with a scientific background and one member with a non-scientific background. The IRB’s function is to protect the safety and rights of volunteers in clinical trials.
Health Insurance Portability and Accountability Act (HIPAA) regulations ensure patient privacy by protecting medical records and other individually identifiable health information. Informed consent is a process in which the researchers communicate all of the important information regarding a study to the potential participant. This process ensures that individuals understand the potential risks and benefits of a clinical trial, as well as alternatives available for a specific condition. Enrollment in a clinical trial is always voluntary, and an individual can leave a study at any time. For further information about IRB, HIPAA and Informed Consent, please visit the United States Department of Health and Human Services site.
References
- FDA Code of Federal Regulations – 21 CFR 56.107
What are the benefits of participating in a clinical trial?
What are the disadvantages of participating in a clinical trial?
What if I volunteer and later change my mind and no longer want to participate?
If I am in a clinical trial, can I continue seeing my regular primary care provider?
Clinical Research Trials
As part of a clinical trial, you may have diagnostic tests, laboratories and procedures completed at no cost as relevant to the particular study. Compensation is often provided for time and travel.
If you are interested in participating in a clinical trial, please call 406-414-4475 or email clinicalresearch@bozemanhealth.org.
We are frequently opening new clinical trials and may be recruiting participants with the following medical conditions:
- Cancer
- Cancer-related Cachexia/Anorexia
- Prostate Cancer
- Breast Cancer
- Lung Cancer
- Colorectal Cancer
- Hematologic malignancies (blood cancers)
For more clinical trial opportunities, please visit the Bozeman Deaconess Cancer Center page or click below:
- More clinical trials are available through Montana Cancer Consortium
- ClinicalTrials.Gov: A service of the U.S. National Institutes of Health
- National Comprehensive Cancer Network (NCCN)
- American Cancer Society
- Gastroenterology
- Eosinophilic Esophagitis (EoE)
- Erosive Esophagitis (EE)
- Ulcerative Colitis (UC)
- Healthy Volunteer vaccine studies (no medical conditions required to participate)
- RSV
- Influenza
- COVID-19
- Human Metapneumovirus (hMPV)
- Diabetes, Endocrinology, and Obesity studies
- Obesity
- Type 2 Diabetes
- And other conditions not listed
Current Studies - Now Enrolling
Pfizer C4391024 (FourLight-3)
Study Title
Purpose
The purpose of this study is to evaluate whether PF-07220060 plus letrozole can improve clinical outcomes relative to cyclin-dependent kinase (CDK) 4/6 inhibitor (CDK4/6i)
(Investigator’s choice: abemaciclib, palbociclib or ribociclib) plus letrozole in participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (a/mBC) who have not received any prior systemic anticancer treatments for advanced/metastatic disease.
Detailed Description
Approximately 1020 adult participants with a/mBC will be assigned to one of two cohorts (Investigational Arm A and Comparator Arm B) and randomized in a 1:1 ratio to receive either PF-07220060 plus letrozole Investigational Arm) or CDK4/6i plus letrozole. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, unacceptable toxicity, death or withdrawal of consent, whichever occurs first.
Independent third-party external data monitoring committee (E-DMC) will monitor the safety and interim efficacy of the participants on a periodic basis as defined by the E-DMC charter.
Eligibility
This study is open to enrollment for adults (18+) diagnosed with metastatic/locally-advanced HR positive and HER2 negative breast cancer which is not amenable to surgical resection or radiation therapy with curative intent and have not yet begun treatment for locally advanced or metastatic disease.
Other eligibility criteria apply and will be assessed during a 28-day screening period before any study treatments begin. If you are interested in participating in this clinical trial, please call
406 414-4475 or email
Clinicalresearch@bozemanhealth.org.
Additional details may be found at ClinicalTrials.gov.
iCaRe² – BCCR
Study Title
Integrated Cancer Repository for Cancer Research (iCaRe²) – Breast Cancer Collaborative Registry
Purpose
This registry is part of a larger registry, iCaRe2 administered by the University of Nebraska Medical Center (UNMC). This registry is focused on the collection of detailed information on participants to create a resource that will be helpful to cancer researchers to study risk factors for a number of different types of cancer and other diseases, which relate to cancer.
It is our hope that future research suing information from this registry will lead to improved diagnosis, prevention and cancer treatment.
Detailed Description
Participants will complete a survey about their medical history, diet and lifestyle habits, environmental exposures and family history. Participants will allow authorized personnel to contact them to obtain consent for additional uses of stored medical history information, to obtain updated or additional information, or to be contacted to participate in other research projects.
Participants will complete an initial survey online that can take up to one hour and those who have had or currently have cancer will be asked to complete annual follow-up surveys.
Eligibility
This study is open to enrollment for adults (19+) who have a personal diagnosis of breast cancer, who have a risk for developing cancer or suspicious clinical findings, or with no history of cancer for normal control registry.
If you are interested in participating in this registry study, please call Kelly Burningham at (406) 414-3743 or email kburningham@bozemanhealth.org
Merck MK2140-011 (Opening Soon)
Study Title
A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)
Purpose
The purpose of this trial is to compare zilovertamab vedotin (MK-2140) plus a combination of cancer drugs called R‑CHP with polatuzumab vedotin plus R-CHP in people with a specific type of Diffuse Large B-cell Lymphoma (DLBCL) GCB (Germinal center B-Cell) Subtype to:
- Test the safety of the trial drug, zilovertamab vedotin plus R-CHP
- See how well zilovertamab vedotin plus R-CHP works compared to polatuzumab vedotin plus R-CHP
- See if participants who get zilovertamab vedotin plus R-CHP live longer compared to those who get polatuzumab vedotin plus R-CHP
- See if participants who get zilovertamab vedotin plus R-CHP have a better quality of life compared to those who get polatuzumab vedotin plus R-CHP
Detailed Description
Adult participants will be randomized in a 1:1 ratio to receive either zilovertamab vedotin + R-CHP or polatuzumab vedotin + R-CHP for six (6) 21-day cycles of treatment. Patients with a high risk of recurring disease may get another two (2) cycles with rituximab. After the completion of treatment, patients will be followed for up to 5 years for scans and health checks.
Eligibility
This study is open to enrollment for Adults (18+) who have been diagnosed with the GCP subtype of Diffuse Large B-Cell Lymphoma (DLBCL) and have not been previously treated for this disease.
Other eligibility criteria apply and will be assessed during a 28-day screening period before any study treatments begin. If you are interested in participating in this clinical trial, please call (406) 414-4475 or email Clinicalresearch@bozemanhealth.org. Additional details may be found at ClinicalTrials.gov.
(EvoPAR Prostate-01)
Study Title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician’s Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Purpose
We are doing this research to find out if the experimental drug (study drug) called Saruparib (AZD5305) combined with new hormonal agents (NHAs) (enzalutamide, abiraterone, or darolutamide) works better for the type of cancer that you have been diagnosed with, when compared to NHAs alone.
This study will also evaluate other aspects such as: how much of saruparib is in your blood at various times and if there are molecular biomarkers of prostate cancer in your blood that could help monitor the disease.
Detailed Description
Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.
All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physician’s choice NHA.
Eligibility
This study is open to enrollment for adults (18+) diagnosed with metastatic castration-sensitive prostate cancer who have not yet begun treatment for metastatic disease (with the exception of Androgen Deprivation Therapy (ADT) started within 3 months prior to enrollment into screening for the study). Other eligibility criteria apply and will be assessed during a 28-day screening period before any study treatments begin.
If you are interested in participating in this clinical trial, please call 406-414-4475 or email Clinicalresearch@bozemanhealth.org. Additional details may be found at ClinicalTrials.gov.
BNT327-02
Study Title
Purpose
Detailed Description
Participants will be treated until disease progression, intolerable toxicity, participant withdrawal, death, study termination or up to 2 years (whichever occurs first).
The study plans to randomize or assign eligible participants into two cohorts, i.e., Cohort 1 and Cohort 2. In Cohort 1, participants will be randomized to two treatment arms investigating two dose levels of BNT327 in combination with Nab-paclitaxel.
Cohort 2 will not begin until the appropriate dose to move forward has been determined from Cohort 1. After this, the arms in Cohort 2 exploring different chemotherapy combinations will begin to enroll. Participants in Cohort 2, Arm 1 will receive the optimal dose of BNT327 in combination with paclitaxel. Participants in Cohort 2, Arms 2 and 3, will receive the equivalent dose of BNT327 administered once every 3 weeks (Q3W) in combination with gemcitabine plus carboplatin (Arm 2), or eribulin (Arm 3).
Eligibility
This study is open to enrollment for adults (18+) diagnosed with inoperable metastatic/locally-advanced Triple-Negative Breast Cancer (TNBC) who have not yet begun treatment for metastatic disease or have failed one prior line of systemic therapy for locally-advanced or metastatic disease. Other eligibility criteria apply and will be assessed during a 21-day screening period before any study treatments begin.
If you are interested in participating in this clinical trial, please call 406-414-4475 or email Clinicalresearch@bozemanhealth.org. Additional details may be found at ClinicalTrials.gov.
(RELATIVITY-1093)
Study Title
Purpose
Detailed Description
CA2241093 is an open-label, randomized trial to evaluate the safety and efficacy of the nivolumab + relatlimab FDC (1:1) + PDCT Q3W (Arm A) vs pembrolizumab (200mg) + PDCT (Q3W) (Arm B). Participants will be randomized 1:1 into the experimental arm (Arm A) and the control arm (Arm B). Immunotherapy administration will continue until progression, toxicity, withdrawal of consent, or a maximum of 2 years, whichever occurs first. PDCT administration occurs for the first 4 cycles only (maintenance pemetrexed permitted). Enrollment will end when approximately 1000 participants have been randomized. Participants must have ≥ 1% PD-L1 tumor cell expression.
Eligibility
This study is open to enrollment for adults (18+) diagnosed with Stage Iv or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) Histology, and with a PD-L1 expression of ≥ 1%, who have not yet begun treatment for metastatic disease. Other eligibility criteria apply and will be assessed during a 32-day screening period before any study treatments begin.
If you are interested in participating in this clinical trial, please call 406-414-4475 or email Clinicalresearch@bozemanhealth.org. Additional details may be found at ClinicalTrials.gov.
