Clinical Trials and Research Programs

Cancer Experience Registry Survey is about your cancer experience. Allows our Cancer Institute to continually enhance our design of support services, effective policy and impactful research www.cancerexperienceregistry.org/join/DH

NRG-BR003

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node Negative, Triple-Negative Invasive Breast Cancer

• To determine if the addition of carboplatin to an adjuvant chemotherapy regimen of AC + T will improve invasive disease free survival in patients with triple negative breast cancer

S1418

A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1cm Residual Invasive Cancer of Positive Lymph Nosed After Neoadjuvant Chemotherapy*

• To compare iDFS of patient population receiving Pembrolizumab compared to no Pembrolizumab
• May enroll after treatment with Xeloda

S1703

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer*

• To assess whether patients monitored with STMDDM have non-inferior OS compared to patients monitored with usual care (imaging).

IRONMAN

Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men with Advanced Prostate Cancer

• International study
• Non-therapeutic prospective registry
• Metastatic hormone sensitive prostate cancer
• Castration resistant prostate cancer
• To describe the practice patterns of therapeutic agents for treatment of advance prostate cancer internationally
• To assess whether specific treatment patterns are associated with clinically significant adverse events and evaluate potential interactions with concomitant medications or demographic factors
• To identify associations between treatment sequences or combinations and overall survival
• To define the patient experience of men with advance prostate cancer and identify unmet needs in their treatment
• To identify clinical and molecular disease subtypes that predicts response to individual treatments, combination, or sequences.
• Blood biomarkers
• Physician questionnaires with changes in treatment

PROPEL

PROmoting Prostate Cancer Engagement and Learning: Feasibility of Digital Health Coaching for Men with Prostate Cancer

• Men who have been treated for prostate cancer within two years
• Will receive virtual health coaching through digital platform Pack Health
• Weekly contact with coach via text, email or phone for 12 weeks
• Coaches provide resources to help achieve health and wellness goals while living with prostate cancer
• Complete surveys every 4 weeks

NRG-GI005 (COBRA)

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA colon Cancer (COBRA)

• To determine whether to recommend chemotherapy or no further treatment after surgery for an early stage colon cancer by taking a blood sample and testing for the presence of circulating tumor DNA
• Patient must be “suitable for active surveillance” i.e. the physician decides no adjuvant chemotherapy is needed

A081801 (ALCHEMIST I-O)

Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST I-O

• Stage IB-IIIA resected NSCLC
• Compares DFS and OS between combination or sequential Pembrolizumab plus standard of care vs. standard of care

A031501 (AMBASSADOR)

Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation*

• To determine DFS and OS in patients treated with Pembrolizumab versus observation
• Tissue sample for Central PD-L1 testing for stratification purposes

NCI-MATCH/EAY131

National Cancer Institute – Molecular Analysis for Therapy Choice

• Phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of its type
• Solid tumor, lymphoma, or myeloma that has returned or gotten worse after standard systemic therapy
• Any cancer for which no standard treatment exists that has been shown to prolong overall survival
• Patients identified when tumor gene testing done by designated laboratories

TAPISTRY

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for Your (TAPISTRY) Phase II Platform Trial

• Evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patient with solid tumors
• Biomarkers include: ROS1 fusion (non-NSCLC), NTRK1/2/3 fusion, ALK fusion (non-NSCLC), PIK3CA multiple mutations, AKT1/2/3 mutation, HER2 mutation, MDM2-amplified, TP53 wild-type, and TMB-high (>/= 16 mut/Mb)

NCI-COVID

NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

• To determine how COVID-19 affects the outcomes of people undergoing cancer treatment
• To determine how having cancer affects COVID-19
• Collection of blood samples, medical imaging, medical and cancer history
• Must enroll within two weeks of positive COVID-19 test

For more information about Doylestown Health's open cancer trials visit the U.S. National Institutes of Health's Clinical Trials database.