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
Study Title
The Caris Biorepository Research Protocol
Purpose
The Caris Biorepository Research Protocol is designed to advance precision medicine and improve patient care by analyzing biospecimens and better understand why certain diseases respond to some treatments or how certain diagnoses are made.
Research using biospecimens is an important way to try to understand human health and medical conditions, and to learn how to protect health and prevent, treat, or cure conditions such as cancer
Detailed Description
After Informed Consent, participants will provide a blood sample of approximately 2 tablespoons to the research team, who will ship the sample to Caris Biosciences to study how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding. When Caris receiveds your sample, a small part of the sample may be used to evaluate sample quality and ensure the specimen is usable for research.
Along with the biospecimen (i.e., blood sample), the research team will collect some medical information that will be paired with each sample collected and used to further define the characteristics of the sample provided.
This information may include: Age, ethnicity, diagnosis, disease history, medical treatments, family medical history, etc.. Both information and biopspecimen samples will be deidentified and stored securely by Caris.
Eligibility
Bozeman Health Clinical Research is enrolling participants into three different cohorts for participation in the Caris Biorepository.
Pre-Mammogram cohort:
- Female ≥ 18 years of age
- Bozeman Health patients who are scheduled to receive a mammogram as part of their routine care
- Can NOT have a previous cancer diagnoses (with the exception of non-melanoma skin cancer)
- Can NOT be actively lactating or pregnant
Breast Pre-Biopsy cohort:
- Female ≥ 18 years of age
- Bozeman Health patients who are scheduled for a diagnostic breast biopsy as part of their routine care
- Can NOT have a previous cancer diagnoses (with the exception of non-melanoma skin cancer)
- Can NOT be actively lactating or pregnant
Pan-Cancer cohort:
- Male or Female ≥ 18 years of age
- Patient must have received a new diagnosis of a solid tumor cancer within the past 3 months.
- Patient must NOT have received any form of cancer treatment including: Surgical intervention, radiation therapy, and/or systemic therapy (e.g. chemotherapy/Immunotherapy)
- Can NOT have a previous cancer diagnoses (with the exception of non-melanoma skin cancer)
- Can NOT be actively lactating or pregnant
Pfizer C5851005 (PADL1NK-005)
Study Title
PADL1NK-005: A study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Purpose
The purpose of this study is to determine whether monotherapy treatment with investigational drug (PF-08046054/SGN-PDL1V) improves clinical outcomes compared with another standard-of-care (SOC) treatment with docetaxel monotherapy in participants with locally-advanced, unresectable, or metastatic Non-Small-Cell Lung Cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, who experienced disease progression during or after unsuccessful treatment with platinum-based chemotherapy, Programmed Cell Death Ligand 1 (PD-L1) inhibitors, or targeted treatment regimen(s) for patients with known actionable genomic alterations (AGA
Detailed Description
Approximately N=680 adult participants will be randomized in a 1:1 ratio to receive either PF-08046054/SGN-PDL1V or Docetaxel. Participants randomized to the investigational treatment arm will receive PF-08046054 on Day 1 and Day 8 of each 21-day cycle, and participants randomized to the control arm will receive docetaxel on Day 1 of every 21-day cycle.
Imaging assessments will be conducted periodically throughout the treatment period and participants may continue on the study treatment until disease progression, unacceptable adverse events occur, pregnancy, or either the Investigator or participant decides it is not in the participant’s best interest to continue. The total duration of study participation for each participant will vary and participant outcomes will be followed until the study closes or a qualifying event occurs.
Eligibility
This study is open to enrollment for adult patients who have been diagnosed with NSCLC that is locally-advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy, or metastatic disease, have a PD-L1 expression on ≥ 1% of cells, and have been previously treated with platinum-based combination therapy for the treatment of metastatic or recurrent 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 the Bozeman Health Clinical Research Department at (406) 414-4475 or email Clinicalresearch@bozemanhealth.org.
Additional details may be found at Clinicaltrials.gov
Merck MK2140-011
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.
