Cancer clinical trials

More people are living longer thanks to successful cancer treatments resulting from clinical trials. Before new treatments are introduced to patients, they are first studied in the laboratory.

Once preliminary research indicates the possible benefits of a new treatment, clinical trials go through three phases. Phase 1 tests for safety, Phase 2 tests for effectiveness, and Phase 3 tests for both safety and effectiveness in a larger group of patients.

Only after a new treatment passes all three clinical trial phases is it then cleared for general use. All approved cancer treatments available today began as clinical trials.

High-level patient care — Participants receive close monitoring and guidance by clinical trial coordinators and their oncologist.

Access to promising new treatments — Participants may receive a treatment that will be more effective than the standard treatment, and unavailable outside of a clinical trial.

Better treatments — Participants help expand researchers' knowledge and determine whether new treatments will improve outcomes for future patients with cancer.

There may be some costs associated with participating in a trial. Most patients are responsible for copays and deductibles as they would be if they were receiving treatment outside of a clinical trial. The research team will discuss any possible costs with you prior to enrolling.

Ask your doctor if any study at Sharp may be appropriate for you. Your doctor should explain the criteria for trial eligibility, including the stage of cancer being studied; how results will be evaluated; and the potential benefits and risks, such as side effects or other health impacts.

You will receive an informed consent form outlining the purpose of the clinical trial and the risks involved. If there is anything on the form that you do not understand, ask your doctor before signing.

During a clinical trial, you will be monitored and observed closely. If at any time you or your doctor believes the treatment is not in your best interest, you can leave the study.

• SHCGBM-002, Evaluation of HER-2 Receptor Expression and HER-2/neu Gene Amplification in Glioblastoma Patients, Amtower Foundation

• A071701, Genomically-guided Treatment Trial in Brain Metastases (NCT03994796), Alliance for Clinical Trials in Oncology

• INCB 54828-209 A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209) (NCT05267106), Incyte Corporation

• NAS-101 A Phase 1, Sequential Cohort, Open-Label, Dose-Escalation Study of the Safety and CNS Exposure of Pritumumab in Patients with Brain Cancer (NCT04396717), Nascent Biotech

• EF-32 (Trident): A Pivotal Randomized, Open-Label Study of Optune® (TTFIELDS, 200KHZ) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (NCT04471844)

• AFT-25, Comparison Of Operative To Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial (NCT02926911), Alliance Foundation Trials, LLC

• D9673C00007, An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12) (NCT04739761), AstraZeneca

• D8534C00001, SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor A ctDNA Guided Early Switch Study (NCT04964934), AstraZeneca

• V2000701, A Phase 3 Study to Evaluate the Efficacy and Safety of Enobosarm in Combination with Abemaciclib (Enobosarm Combination Group) compared to Estrogen Blocking Agent (Control Treatment Group) for the Second Line Treatment of ER+HER2- Metastatic Breast Cancer in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent plus Palbociclib, Veru Inc.

• A021502, Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT02912559), Alliance for Clinical Trials in Oncology

• 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 Therapy (NCT04793958), Mirati Therapeutics, Inc.

• EF-25, METIS: Pivotal, open-label, randomized study of radiosurgery with or without tumor treating fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC) (NCT02831959), NovoCure Ltd.

• D9103C00001, A phase III, randomized, placebo-controlled, double-blind, multicenter, international study of Durvalumab following stereotactic body radiation therapy (SBRT) for the treatment of patients with unresected stage I/II, lymph-node negative non-small cell lung cancer (PACIFIC-4/RTOG-3515) (NCT03833154), AstraZeneca

  
  
  

• ME-401-003, A Multicenter, Open-Label, Single-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies (NCT03768505), MEI Pharma, Inc.

• INCMOR0208-301, A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma, (NCT04680052), Incyte Corporation

• MOR208C310, MorphoSys AG / “A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high- intermediate and high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL)”, (NCT04824092), MorphoSys AG

• S2000, A Randomized Phase 2 Trial Of Encorafenib + Binimetinib + Nivolumab Vs Ipilimumab + Nivolumab In Brafv600-Mutant Melanoma with Brain Metastases (NCT04511013), Southwest Oncology Group

• 18-0402, A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (NCT04068896), NGM Biopharmaceuticals, Inc.

• S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (NCT02834013), National Cancer Institute

• A031704, PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs VEGF TKI cabozantinib with nivolumab: A Phase III Trial in metastatic untreated Renal Cell Cancer (PDIGREE) (NCT03793166), National Cancer Institute

• EAY131, Molecular Analysis for Therapy Choice (MATCH) (NCT02465060), National Cancer Institute

• 18-0402, A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (NCT04068896), NGM Biopharmaceuticals, Inc.

• DF1001-001, A phase I/II, first-in-human, multipart, open-label, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of DF1001 in patients with locally advanced or metastatic solid tumors, and expansion in selected indications (NCT04143711), Dragonfly Therapeutics

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc.

• TEMPS-101, A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations (NCT05169437), Tempus Labs