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Participate in a Clinical Trial at Comprehensive Hematology Oncology

A clinical trial is a research conducted on study drugs and treatments to test their effectiveness on human health outcomes. These trials are composed of volunteers that qualify for specific studies to test out new drugs and treatments to help physicians obtain a better knowledge of how to diagnose, treat, and prevent these diseases. Taking part in a Clinical trial could not only benefit you or other cancer patients but is one of the most significant attributions in making progress against cancer.

Clinical trials are essential in comprehending all aspects of medicine with the primary objective of helping patients live longer, and improve their quality of life. Clinical trials can consist of new drugs not yet approved by the U.S.Food and Drug Administration, new uses of drugs already approved by the FDA, and new ways to give drugs, such as in pill form. These trials will help physicians and future studies produce the highest-quality data for the healthcare industry.

Clinical trials are one of the best ways to acquire significant knowledge in treating diseases like cancer. The patient’s who volunteer to be a participant in these clinical trials at Comprehensive Hematology Oncology; will receive the most state-of-the-art cancer treatments that are available. By participating in these clinical trials, patients may discover new treatments before they are openly available to the public.

To find out if you could participate in a Clinical trial, discuss with your oncologist to decide if there is a trial that is appropriate for your cancer diagnosis and stage. Here at Comprehensive Hematology, we have a Research team who can provide you with assistance to any additional questions you may have about the Clinical trials we have to offer.

Prior to deciding whether a clinical trial is the right treatment for you, make sure you are provided with all the information needed. Clinical trials can offer hope for many cancer patients. Almost all of the cancer-fighting drugs and treatments that are presently available to patients exist due to significant testing in a clinical trial. The best way to decide if you are making the right choice for your health is by taking the time to get as much knowledge needed in helping you make that decision.

Clinical Trial Phases

Clinical Trials involve a series of steps called “phases”. There are 4 phases of a clinical trial. The main phases are Phase I, Phase II and Phase III. The different phases will provide physicians with significant information about the treatment being studied.

Phase I

One of the most critical phases. The drug will be tested in a small group of 15 to 30 patients. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.

Phase II

Phase II further asses the drug’s safety and efficacy.  Phase II is usually tested in much larger groups than Phase I studies usually with a focus on a certain type of cancer. In majority of the cases, the drug being tested is not compared to the drug currently being used but tested to see if the drug works.

Phase III

Phase III is a comparative phase. This phase compares new treatment with the current standard treatment. This phase enrolls 100 or more patients.

Patients are randomly put into a treatment group to ensure that the results of the clinical trial are based upon treatment and not due to grouping of individuals. Every patient is watched closely. The study will be stopped early if the side effects of the new drug are too severe or if one group has much better results. After passing phase III, the new treatment will be submitted to the FDA for approval.

Phase IV

After being approved by the FDA, the drug is tested amongst few hundred to thousands of patients. This level of testing allows to better understand and research the short and long-term side effects of safety of the approved drug. This phase also helps physicians understand more about how well the drug functions and its usefulness alongside other treatments.

Available Trials

AYALA

AL-TNBC-01 is a Phase 2, Single- arm study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Condition or Disease: Triple Negative Breast Cancer

Description: This clinical trial is a phase 2, Multicenter, Open-label, and Single-arm Study of AL101 Monotherapy in patients with triple negative breast cancer. The sponsor is studying the efficacy of AL101 drug in patient with Notch-activated Triple Negative Breast cancer.

Phase: Phase 2

Study Drug: AL101

Sponsor: Ayala Pharmaceuticals, INC. Wilmington DE

Regeneron

REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients with Lung Cancer

Condition or Disease:  Non-Small Cell Lung Cancer

Description: The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as “REGN2810/chemo/ipi”) with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

Phase: Phase 3

Study Drug:  REGN2810, Pembrolizumab

Sponsor: Regeneron Pharmaceuticals, Inc.

Isofol

A Study to Compare the Efficacy of Arfolitixorin versus Leucovorin in Combination with 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients with Advanced Colorectal Cancer (AGENT)

Condition or Disease: Colorectal Cancer

Description: This is a multicenter, randomized, parallel-group, Phase III study with at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

 Phase: Phase 3

Study Drug: Arfolitixorin,Leucovorin

Sponsor: Isofol Medical AB (publ), Gothenburg, Sweden

KHK

KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects with Advanced Bladder Cancer

Condition or Disease: Urothelial Cancer

Description: This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).

 Phase: Phase 1

Study Drug: KHK2455: Avelumab

Sponsor:  Kyowa Kirin Pharmaceutical Development, Inc, Princeton, NJ

IMV

Study of an Immunotherapeutic, DPX-Survivac, in Combination with Low Dose Cyclophosphamide & Pembrolizumab, in Subjects with Selected Advanced & Recurrent Solid Tumors

Condition or Disease: Ovarian Cancer Hepatocellular Carcinoma Non-small Cell Lung Cancer Bladder Cancer Microsatellite Instability-High

Description: This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

Phase: Phase 2

Study Drug: DPX-Survivac Drug: Cyclophosphamide Drug: Pembrolizumab

Sponsor: IMV,Inc. Dartmouth, Nova Scotia, Canada.

Regenix

A Study of RGX-104 in Patients with Advanced Solid Malignancies and Lymphoma

Condition or Disease: Malignant Neoplasm.

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent and in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed. RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.

Phase: Phase 1

Study Drug:  RGX-104 Drug: Nivolumab Drug: Ipilimumab Drug: Docetaxel Drug: Pembrolizumab Drug: Carboplatin Drug: Pemetrexed

FLX

Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab
Condition or Disease: Advanced Cancer

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Phase: Phase 1, Phase 2

Study Drug: FLX475 Drug: Pembrolizumab

Sponsor: RAPT Pharmaceuticals.

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