Clinical Trials

Clinical trials are how new treatments and improved outcomes are developed in health care. Highlands Oncology Group has been participating in clinical trials for over 20 years. Our Research Department operates numerous clinical trials in both oncology and hematology. New experimental medications, or different ways to use existing medications, are compared to the currently available treatments in order to advance cancer care for patients around the world.

Each clinical trial has certain criteria that must be met to participate. These guidelines help protect the safety of each patient. There are four phases of clinical trial development:

  • Phase I – Assessing medication dose and safety
  • Phase II – Further assessing safety and efficacy
  • Phase III – Comparison to currently available medications
  • Phase IV – Further study of already FDA-approved medications

Phase I clinical trials provide new, novel approaches for the treatment of cancer. Highlands Oncology Group has the privilege of being the only community based Phase I oncology clinical trial center in the state of Arkansas. Cancer research is always evolving and new treatments emerge every year. Highlands Oncology Group stays at the cutting edge of technology with help from the Research Department and clinical trials.

We strive to provide as many options as possible for the treatment of cancer. Only you and your doctor can decide if a clinical trial is right for you. If you are interested in participating in a clinical trial, please review our list of currently enrolling clinical trials. For further information on clinical trials, please visit http://www.clinicaltrials.gov.

For questions or more information, please contact the Research Department:

  • By email: [email protected]
  • By phone: 479-872-8130
  • Contact Highlands Oncology Group: 479-587-1700
Novartis BYL719K12301: A Phase III, Multi-Center, Randomized (1:1), Open-Label, Active-Controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination with Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants with no Germline BRCA Mutation Detected, Platinum-Resistant or Refractory, High-Grade Serous Ovarian (EPIK-O)OVARIAN07/08/2021View Here
VX152503-12: A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients with Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckHEAD/NECK06/17/2021View Here
IMMU-132-11: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid TumorsSolid Tumors06/16/2021View Here
IMMU-132-11: Phase 2 open label study of Sacituzumab Govitecan (IMMU-132) in subjects with metastatic solid tumors:Solid Tumors06/16/2021View Here
Pfizer C3661001: Phase 1/2a Dose Escalation and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Anti-Tumor Activity of PF-06873600 as a Single Agent and in Combination with Endocrine TherapySolid Tumors05/03/2021View Here
Vaccinex VX15/2503-12: A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients with Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.HEAD/NECK04/29/2021View Here
EC120888: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic AssayLUNG - Non Small Cell Cancer (NSCLC)04/22/2021View Here
TG-1801-102: “A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination with Ublituximab in Subjects with B-Cell Lymphoma or Chronic Lymphocytic Leukemia”LEUKEMIA - Chronic Lymphocytic04/07/2021View Here
Hutchison 2020-013-00US3: An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Triple Negative Breast CancerBREAST03/26/2021View Here
Mirati 849-010: A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line TherapyCOLORECTAL03/15/2021View Here
Eli Lilly I3Y-MC-JPCW: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted TherapyBREAST03/09/2021View Here
Sarah Cannon BRE 354: A Phase II Study of U3-1402 in Patients with Metastatic Breast CancerBREAST03/04/2021View Here
AbbVie M20-124: A Phase 1, Multi-center, Open Label First-in-Human Study with ABBV-CLS-579 Alone and in Combination with Anti-PD-1 in Subjects with Locally Advanced or Metastatic TumorsSolid Tumors03/01/2021View Here
PEN-866-001: A Phase 1/2a, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PEN-866 in patients with advanced solid malignanciesSolid Tumors02/22/2021View Here
M20-124: A Phase 1, Multi-center, Open Label First-in-Human Study with ABBV-CLS-579 Alone and in Combination with anti-PD-1 in Subjects with Locally Advanced or Metastatic TumorsSolid Tumors02/19/2021View Here
Laekna LAE002INT2001: 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 CancerOVARIAN11/23/2020View Here
AstraZeneca D9670C00001 (DESTINY-06): A Phase 3, 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 SettingBREAST11/23/2020View Here
Mirati 516-005: A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab vs Docetaxel in Patients with Advanced Non-Squamous, Non-Small Cell Lung Cancer with Disease Progression on or after Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (CIT)LUNG - Non Small Cell Cancer (NSCLC)11/04/2020View Here
AbbVie M16-191: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis (TRANSFORM-1)OTHER10/01/2020View Here
Novartis CACZ885T2301: A Phase III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Canakinumab versus Placebo as Adjuvant Therapy in Adult Subjects with Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cmN2) Completely Resected (RO) Non-Small Cell Lung Cancer (NSCLC)LUNG - Non Small Cell Cancer (NSCLC)09/22/2020View Here
Novartis CACZ885V2201C: A Randomized, Open-Label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy and in Combination as Neoadjuvant Therapy in Subjects with Resectable Non-Small Cell Lung CancerLUNG - Non Small Cell Cancer (NSCLC)09/22/2020View Here
AbbVie M19-037: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects with Locally Advanced or Metastatic Solid TumorsOTHER07/14/2020View Here
Novartis CBYL719G12301: A Two Part, Phase III, Multicenter, Randomizied (1:1), Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Alpelisib (BLYl719) in Combination with Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-Positive Advanced Breast Cancer with a PIK3CA MutationBREAST06/11/2020View Here
Eli Lilly J2J-MC-JZLA: EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast CancersBREAST06/04/2020View Here
Ultimovacs UV1-202: A Randomized Phase II, Open-Label, Active-Controlled, Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-Line Treatment of Patients with Unresectable or Metastatic MelanomaMELANOMA05/28/2020View Here
Ascentage Pharma HQP1351CU101: A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects with Refractory Chronic Myeloid Leukemia (CML)LEUKEMIA - Chronic Myelogenous05/14/2020View Here
AbbVie M14-239: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung CancerLUNG - Non Small Cell Cancer (NSCLC)03/11/2020View Here
TG Therapeutics TG-1501-101: A Phase I Study of TG-1501 in Subjects with Relapsed or Refractory LymphomaLYMPHOMA02/20/2020View Here
AbbVie M16-573: A Phase I First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid TumorsOTHER02/06/2020View Here
AbbVie M19-611: A Phase Ib Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung CancerLUNG - Non Small Cell Cancer (NSCLC)01/09/2020View Here
Nektar 16-214-05: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combination with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid TumorsOTHER11/15/2019View Here
Seattle Genetics SGN35-015: A Phase II Open-Label Study of Brentuximab Vedotin in Front-LineTherapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Older Patients or Patients with Significant Comorbidities Ineligible for Standard ChemotherapyLYMPHOMA11/06/2019View Here
Bristol-Myers Squibb CA20976K: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CheckMate 76K: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 76K)MELANOMA09/24/2019View Here
Ascentage Pharma APG-115-US-002: A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid TumorsOTHER09/10/2019View Here
AbbVie M17-327: A Phase 1 Study of ABBV-011 as a Single-Agent and in Combination with Budigalimab (ABBV-181) in Subjects with Relapsed or Refractory Small Cell Lung CancerLUNG - Small Cell Cancer (SCLC)04/17/2019View Here
Seattle Genetics SGN22E-002: A Study of Enfortumab Vedotin (ASG-22CE) a Monotherapy or in Combination with Other Anticancer Therapies for the Treatment of Urothelial CancerOTHER12/06/2018View Here
Southwest Oncology Group (SWOG) S1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare TumorsOTHER04/10/2018View Here
Bristol-Myers Squibb CA209914: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who are at High Risk of RelapseRENAL CELL06/26/2017View Here
TG Therapeutics UTX-TGR-204: A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination with Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304LEUKEMIA - Chronic Lymphocytic04/21/2017View Here