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.

• A072201, Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma NCT06325683, Alliance for Clinical Trials in Oncology

• A072301, Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer NCT07215910, Alliance for Clinical Trials in Oncology

• SHCGBM-003, Evaluation of Claudin-18.2 receptor expression in Glioblastoma Patients. This study is non-interventional. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.

• A012301: LoTam, A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer, (NCT06671912), Alliance for Clinical Trials in Oncology

• Beamion BCGC-1, A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, (NCT06324357), Boehringer Ingelheim

• MCLA-158-CL01, A Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors, (NCT03526835), Merus N.V.

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc.

• Beamion BCGC-1, A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, (NCT06324357), Boehringer Ingelheim

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc. This study is non-interventional. For more information, please contact a Sharp Clinical Trials Specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.

• D702FC00001, A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03), (NCT06627647), AstraZeneca

• TROPION-Lung14, A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer, (NCT06350097), AstraZeneca

• TROPION-Lung15, A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer, (NCT06417814), AstraZeneca

• TROPION-Lung17, A Phase III Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, (NCT07291037)

• PREDAPT-2, A Multicenter Cancer Biospecimen Collection Study (NCT04510129), Cofactor Genomics, Inc. This study is non-interventional. For more information, please contact a Sharp Clinical Trials Specialist at (858) 939-4030 or ClinicalOncologyResearch@sharp.com.

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc.

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc.

• EvoPAR-Prostate02, A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy, (NCT06952803), AstraZeneca

• 5541-CL-0201, A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer, (NCT07005154), Astellas

• 78278343PCR3003, A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer, (NCT07225946), Janssen Research and Development, LLC
  

• EAY191, Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial, (NCT05564377), NCI

• MDNA11-01: ABILITY-1, A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors, (NCT05086692), Medicenna Therapeutics, Inc.

• ES2021-05, Specimen Collection Study to Evaluate Biomarkers in Subjects with Cancer, Exact Sciences Corporation. This study is non-interventional. For more information, please contact a Sharp clinical trials specialist at 858-939-4030 or ClinicalOncologyResearch@sharp.com.