Clinical Trials

welcome to CARTI clinical research

Our research team is currently working with pharmaceutical companies on over 35 clinical trials to bring advancement to oncology medicine. Clinical trials examine the safety and efficacy of new treatments, reduce the time between treatment and response evaluation, improve supportive care medications, monitor treatments in the real world setting and provide biological samples to develop tests for early cancer detection. Here at CARTI we are proud to offer front-line research to our patients. Our goal is to work toward innovation and improvement in standard of care. With a mission of providing the most leading-edge cancer care available, CARTI’s medical team actively participates in research projects that will impact the treatment options we are able to provide our current and future patients.

how do I participate in a clinical trial?

The purpose of our research is to engage in research-driven patient care by offering the most effective new treatment options in order to extend survival, improve quality of life and advance the knowledge of cancer treatment. If you are interested in participating in a clinical trial, ask your physician if you qualify. To make our clinical trials available to all CARTI patients, all of our physicians serve as sub-investigators; this means that your treating physician can enroll you onto a clinical trial if you are eligible. Please refer to the list below to view our active studies!

Participation in research is always voluntary. For further information on clinical trials, please visit http://www.clinicaltrials .gov.

If you have any additional questions for or about CARTI’s Research Team, please call 501.906.4199 or email Research@CARTI.com.

BREAST CANCER TRIALS

Destiny-RESPOND (D9673R00025)

Sponsor: AstraZeneca

Principal Investigator: Dr. Rhonda Gentry

A Multi-Center, Multi-Country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line For HER2+ Unresectable And/Or Metastatic Breast Cancer

HER2Climb-05 (SGNTUC-028)

Sponsor: Seagen

Principal Investigator: Dr. Sam Makhoul

A Randomized, Double-Blind, Phase 3 study of Tucatinib or Placebo in Combination With Trastuzumab And Pertuzumab As Maintenance Therapy For Metastatic HER2+ Breast Cancer

SERENA-6 (D8534C00001)

Sponsor: AstraZeneca

Principal Investigator: Dr. Sam Makhoul

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 + CDK4/6 Inhibitor vs Continuing AI + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with ctDNA Detectable ESR1 Mutation Without Disease Progression During 1L Treatment

Tropion Breast-03 (D926XC00001)

Sponsor: AstraZeneca

Principal Investigator: Dr. Sam Makhoul

A Study of Dato-DXd With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy

VIKTORIA (Celc-G-301)

Sponsor: Celcuity, Inc.

Principal Investigator: Dr. Sam Makhoul

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy

COLORECTAL CANCER TRIALS

ONSEMBLE (CRDF-003)

Sponsor: Cardiff Oncology

Principal Investigator: Dr. Lawrence Mendelsohn

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

LUNG CANCER TRIALS

AVANZAR (D926NC00001)

Sponsor: AstraZeneca

Principal Investigator: Dr. Ryan Hall

A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

MERCK Keynote 867 (3475-867-05)

Sponsor: Merck & Co.

Principal Investigator: Dr. Sam Makhoul

A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC)

HEM MALIGNANCY TRIALS

ESCALADE (D8227C00001)

Sponsor: AstraZeneca

Principal Investigator: Dr. Appalanaidu Sasapu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma

SOLID TUMOR TRIALS

CASE (R2810-ONC-1806)

Sponsor: Regeneron Pharmaceuticals, Inc.

Principal Investigator: Dr. Rhonda Gentry

CemiplimAb Survivorship Epidemiology (CASE) Study

IGNYTE (RPL-001-16)

Sponsor: Replimune, Inc.

Principal Investigator: Dr. Sam Makhoul

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

PRO-ACC1 (C3651003)

Sponsor: Pfizer

Principal Investigator: Dr. Ryan Hall

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Investigate the Efficacy, Safety and Tolerability of Ponsegromab in Patients With Cancer, Cachexia, and Elevated Concentrations of GDF-15, Followed By an Optional Open-Label Treatment Period

INVESTIGATIONAL DEVICE TRIALS

CapTEM Y90

Sponsor: University Of Pennsylvania, Dr. Soulen

Principal Investigator: Dr. David Hays

Phase 2 Study of Capecitabile-Temozolomide (CapTem) With yttrium-90 Radioembolization in the Treatment of Patients with Unresectable Metastatic Grade 2 Neuroendocrine Tumors. Device: CTY90 Radioembolization

INSTYLLA (INY-P-20-001)

Sponsor: Instylla, Inc.

Principal Investigator: Dr. Edgar St. Amour

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study. Investigational Device: Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter

CARTI is the #1 site for patient enrollment in the world for Instylla.

CARTI to Serve as First Center in US to Treat Patients Through Embrace Hydrogel Embolic System Global Randomized Multi-Center Clinical Trial

iPredict (IAB-CD8-203)

Sponsor: ImaginAb, Inc.

Principal Investigator: Dr. David Hays

A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell Lung Cancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy. Device/Product Name: zirconium Zr 89 crefmirlimab berdoxam

READY (CUSA-081-HEM-01)

Sponsor: Chiesi

Principal Investigator: Dr. Ryan Hall

A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs). Device: CVAD/reteplase