Clinical Trials

Read Now: The Role of Research Infusion Nurses

Clinical trials are how new treatments and improved outcomes are developed in health care. Highlands Oncology has been participating in clinical trials for over 26 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 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 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: 479-587-1700
Arvinas ARV-471-BC-201: This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.BREAST02/15/2023View Here
Merck MK1026-003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic MalignanciesOTHER02/02/2023View Here
AstraZeneca D967RC00001: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)BREAST01/26/2023View Here
Daiichi Sankyo DS7300-127: A Phase 2, Multicenter, Randomized, Open-label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC)LUNG01/11/2023View Here
Imugene CF33-hNIS-002: This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors.Solid Tumors01/05/2023View Here
Freenome FRNM-008: The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer ScreeningOTHER12/27/2022View Here
Shanghai Henlius Biotech HLX10-005-SCLC301-E: A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORSLUNG - Small Cell Cancer (SCLC)12/12/2022View Here
Eli Lilly J2J-MC-JZLH: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of RecurrenceBREAST11/22/2022View Here
Pfizer C4901001: A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORSSolid Tumors11/11/2022View Here
OncoC4 ONC-392-001: Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)OTHER10/28/2022View Here
Bristol-Myers Squibb CA027-002: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced CancersMELANOMA10/24/2022View Here
Revolution Medicines RMC-6291-001: Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid TumorsLUNG - Non Small Cell Cancer (NSCLC)10/24/2022View Here
Pfizer B9991046: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.Solid Tumors10/24/2022View Here
Sarah Cannon BRE-354: A Phase II Study of U3-1402 in Patients With Metastatic Breast CancerBREAST10/21/2022View Here
Bristol-Myers Squibb CA224-098: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV MelanomaMELANOMA10/19/2022View Here
Seagen Inc., SGN35-033: A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor TreatmentMELANOMA10/17/2022View Here
Ascentage Pharma APG-5918XG101: A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic MalignanciesOTHER10/13/2022View Here
EQRx International EQ 143-301: A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR MutationLUNG - Non Small Cell Cancer (NSCLC)08/09/2022View Here
Guardant 02-MX-002 SHIELD - Screening for High Frequency Malignant Disease (SHIELD)LUNG08/08/2022View Here
iTEOS A2A-005: Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung CancerLUNG - Non Small Cell Cancer (NSCLC)08/08/2022View Here
Eli Lilly I3Y-MC-JPEG: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate CancerPROSTATE07/26/2022View Here
Novartis CLEE011A2412B: A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored StudyBREAST07/07/2022View Here
Daiichi Sankyo: U31402-A-U301- A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI TherapyLUNG - Non Small Cell Cancer (NSCLC)06/08/2022View Here
Takeda TAK573-1501: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple MyelomaMULTIPLE MYELOMA06/03/2022View Here
Bristol-Myers Squibb: CA224-123 - A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (RELATIVITY-123)COLORECTAL06/03/2022View Here
Pfizer C4761001- A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONSMELANOMA05/26/2022View Here
Pfizer: C4201002 - A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES.Solid Tumors05/19/2022View Here
Navire Pharma Inc., Nav-1004: A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS MutationLUNG - Non Small Cell Cancer (NSCLC)05/16/2022View Here
Gritstone Bio, Inc. GO-010: A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer.COLORECTAL04/18/2022View 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>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)LUNG - Non Small Cell Cancer (NSCLC)03/16/2022View Here
Eli Lilly I3Y-MC-JPEF: A Phase 3: Randomized, Double Blind: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Advanced or Metastatic Breast, HR+, HER2-, following progression on a CDK 4/6 Inhibitor and Endocrine Therapy.BREAST01/10/2022View Here
AstraZeneca D967UC00001: Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)BREAST01/03/2022View Here
AstraZeneca D8532C00001 (SERENA-4): A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.BREAST12/06/2021View Here
Mirati Therapeutics Inc. 849-007: Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7.LUNG - Non Small Cell Cancer (NSCLC)11/02/2021View Here
Pfizer C4401001: A Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.Solid Tumors09/30/2021View Here
Seattle Genetics SGNS40-002: An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Subjects with Advance MalignanciesOTHER09/16/2021View Here
Novartis CBYL719K12301: 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
Immunomedics IMMU-132-11: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid TumorsSolid Tumors06/16/2021View 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
Razor Genomics 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 Therapeutics 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 Solid TumorsOTHER03/26/2021View Here
Mirati Therapeutics 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
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
Abbvie M20-178: A Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis (TRANSFORM-2).Myelofibrosis10/02/2020View 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 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
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
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
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
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
Southwest Oncology Group (SWOG) S1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare TumorsOTHER04/10/2018View Here
Biodesix BDX-00146: An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer.LUNG - Non Small Cell Cancer (NSCLC)12/13/2016View Here