Clinical Trials. January RESEARCH LOCATION PHONE FAX Eastside Research Faris/Grove Research

Transcription

1 Clinical Trials January 2019 RESEARCH LOCATION PHONE FAX Eastside Research Faris/Grove Research no main number - use direct numbers Seneca Research Spartanburg Research ITOR Main Pharmacy (864) Angie White Pharm Tech OFFICE LOCATION and ADDRESSES Site Code MAIN NUMBER FAX EASLEY 109 Fleetwood Dr., Suite A, Easley, SC SC055 EASTSIDE 65 International Dr. Greenville SC SC FARIS 900 W. Faris Rd, Greenville SC SC FARIS PEDIATRIC ONCOLOGY 900 W. Faris Rd 2 nd floor, Greenville SC SC099 GREER MEDICAL ONCOLOGY 340 Medical Parkway, Suite 100, Greer, SC GREER RADIATION ONCOLOGY 340 Medical Parkway, Suite 100, Greer SC SC SC Backline Internal use only/ not for patients: GROVE (Butternut) 3 Butternut Dr. Suite B, Greenville SC SC SENECA 131 Lila Doyle Dr. Seneca SC SC SPARTANBURG 120 Dillon Dr., Spartanburg, SC SC056 LAURENS Highway 76 East, Medical Office Bldg 3 rd Floor, Clinton SC SC

2 2 AFTER HOURS VOICE MAIL NUMBERS Physicians/Nurses can leave Patient Information at the following voice mail or extension numbers OFFICE After Hours Number Easley Eastside Faris Med Onc/GYN Extra Numbers or Extensions Dial then the ext ESO Green Pod Nurse - Ext 1200 ESO Purple Pod Nurse - Ext 1216 Triage or ext 2338 MD line or ext 2339 Faris Grove Grove Pod Nurse - Ext. 122 Seneca Giguere - Missy 5141 Spartanburg Documents for all OPEN to accrual protocols can be found on: Clinical Conductor - Protocol Website - no longer available closed in September All Protocol information is now found in Clinical Conductor. HSSC EIRB User name and password are same as your GHS login

3 3 Protocols Are Listed Alphabetically By Disease Site Table of Contents SNAPSHOT OF AVAILABLE STUDIES BY DISEASE SITE... 8 AYA (ADOLESCENT & YOUND ADULT) STUDIES... 8 BRAIN BREAST CARCINOID/ NEUROENDOCRINE/ PNET GASTROINTESTINAL COLORECTAL ANAL GASTRIC / GE JUNCTION LIVER PANCREATIC GENITOURINARY GU: BLADDER (UROTHELIAL) GU: RENAL GU: PROSTATE GU: GERM CELL GU: GYN CERVICAL ENDOMETRIAL (UTERINE) VULVAR LEIOMYSARCOMA OVARIAN, FALLOPIAN TUMBE OR PRIMARY PERITONEAL VAGINAL HEAD AND NECK SALIVARY GLAND TUMORS HEMATOLOGIC HES MDS LEUKEMIA CHRONIC ACUTE RELAPSED/REFRACTORY MAINTENANCE LYMPHOMA: NON-HODKINS LYMPHOMA LYMPHOMA: HODKINS LYMPHOMA LYMPHOMA MANTLE CELL MULTIPLE MYELOMA STEM CELL TRANSPLANT STUDIES LUNG NSCLC SCLC SQUAMOUS CELL MESOTHELIOMA SKIN CANCERS... 39

4 MELANOMA SARCOMA THYROID CANCER RARE TUMORS CANCER CONTROL: ALL CANCER PATIENTS ALL CANCER PATIENTS Solid Tumor CENTER FOR INTEGRATIVE ONCOLOGY & SURVIVORSHIP (CIOS) CIOS/Registry: CIOS/Breast CIOS/Any Cancer Survivors BRAIN CANCER CONTROL GLIOMA New Diagnosis MENIGIOMA Newly Diagnosed Advanced BREAST Cancer Control CCDR OBSERVATIONAL/REGISTRY INTERVENTION/ PREVENTION PRE-OP NEO-ADJUVANT POST NEO-ADJUVANT ADJUVANT ADVANCED/METASTATIC Advanced/Metastatic Triple Negative st line nd Line rd Line Advanced/Metastatic Hormone Receptor Positive, HER-2 Negative st Line BREAST CANCER STAR TRIALS CARCINOID/ NEUROENDOCRINE GASTROINTESTINAL COLORECTAL CANCER CONTROL CCDR INTERVENTION PRE-OPERATIVE ADJUVANT

5 METASTATIC st LINE nd LINE rd LINE ANAL PANCREAS NEO-ADJUVANT- RESECTABLE Locally Advanced Metastatic GENITOURINARY BLADDER (UROTHELIAL) BCG- Naïve High-Grade BCG-Unresponsive Recurrent Neoadjuvant Locally Advanced METASTATIC- PRIOR TREATEMENT RENAL Peri-Operative Advanced GERM CELL PROSTATE CCDR Adjuvant Localized Recurrent Metastatic Disease GYN CANCER CONTROL CERVICAL CCDR Locally Advanced ENDOMETRIAL (UTERINE) CCDR OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL Newly Diagnosed Advanced Recurrent Platinum-resistant Ovarian GYN-VULVA HEAD & NECK Cancer Control Adjuvant SALIVARY GLAND TUMORS HEMATOLOGIC HES GRAFT-VERSUS-HOST DISEASE

6 LEUKEMIA ACUTE NEW DIAGNOSIS/UNTREATED RELAPSED/REFRACTORY CHRONIC Untreated Previously treated/relapsed/refractory MAINTENANCE LYMPHOMA CCDR NHL- Treatment Naive Relapsed/Refractory HODGKINS CCDR Untreated MANTLE CELL MULTIPLE MYELOMA FIRST LINE Relapsed and Refractory MM MYELODYSPLASTIC SYNDROME Registry Trials Previously Untreated Previously Treated STEM CELL TRANSPLANT STUDIES GRAFT vs HOST DISEASE ACUTE LYMPHOBLASTIC LEUKEMIA LYMPHOMA Mantle Cell Lymphoma GERM CELL TUMORS LUNG - NSCLC Cancer Control Adjuvant Advanced/ Stage IV Maintenance after 1st line treatment Unresectable Stage IIIA and IIIB First line nd Line and beyond rd Line LUNG - SCLC SKIN CANCERS MELANOMA SARCOMA

7 Soft Tissue Sarcoma Advanced Ewing Sarcoma THYROID CANCER RARE TUMORS ITOR- INSTITUTE FOR TRANSLATIONAL ONCOLOGY RESEARCH BREAST GYN NSCLC SMALL CELL LUNG nd or 3 rd line SCLC MELANOMA HEMATOLOGIC MDS B-Cell Malignancies AML/MDS/Lymphoma/MM Follicular Lymphoma

8 8 SNAPSHOT OF AVAILABLE STUDIES BY DISEASE SITE AYA (ADOLESCENT & YOUND ADULT) STUDIES NOTE: WHEN ENROLLING ADULT SUBJECTS ON COG AYA STUDIES, CREDIT ENROLLMENT TO NRG AT REGISTRATION. 1. Pediatric MATCH trial (APEC 1621): Pediatric MATCH (Molecular Analysis for Therapy Choice) 2. MATCH (EAY 131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors and diagnosis of lymphoma) Therapeutic Trials: Please contact Pediatric Oncology for protocol and consent at (864) Leukemia 1. COG AALL1331: Risk stratified randomized phase III testing of blinatumomab in FIRST relapse of B- lymphoblastic leukemia (<31 years) 2. AAML 1331: Phase III Study for Patients with Newly Diagnosed APML using ATO and ATRA (<22 years) 3. COG AALL1231 (On Temporary Hold) Phase III Randomized Trial Investigating Bortezomib (NSC# ; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy) (<31 years) 4. COG AALL1621 (On Temporary Hold) Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL) (<22 years) 5. Alliance A (PI-Dr. Giguere) A Phase III Trial To Evaluate The Efficacy Of The Addition Of Inotuzumab Ozogamicin (A Conjugated Anti-Cd22 Monoclonal Antibody) To Frontline Therapy In Young Adults (Ages Years) With Newly Diagnosed Precursor B-Cell ALL Lymphoma 6. COG AHOD1331: A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (chl) in Children and Young Adults CNS 7. COG ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients (<22 years) 8. COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years (<21 years)

9 Sarcomas 9. COG AEWS1221: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# , IND# ) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma (<50 years) 10. COG ARST1321: (Temp closure effective 10/01/18) Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# , IND# ) (any age >2 years) Germ cell tumor 11. COG AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors (<50 years) 12. Alliance A (PI Dr. Giguere) A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors. Biology studies 1. AALL05B1 2. AALL08B1 3. ANBL00B1 4. AREN03B2 Non-interventional study 1. WFU (WAYS) (PI= Dr. Giguere) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) 9

10 BRAIN CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute 3. Body Composition Changes During Cancer Treatment Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device 5. WISE- Walking Inspires Seniors Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors Cancer Control 1. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors 2. Alliance A (Call Tranaka ) A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil ) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma 3. NRG CC003 (Temp hold effective 10/13/17 for at least one year) Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance For Small Cell Lung Cancer 4. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) 5. WFU 1801 (PI-Dr. Giguere) A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy New Diagnosis 1. CTSU N0577 Phase III Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Codeleted Anaplastic Glioma or Low Grade Glioma 2. COG ACNS 0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Ri Medulloblastoma/ PNET Patients (<22 years) 10

11 3. COG ACNS 0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years (<21 years) 4. NRG BN003 Phase III Trial Of Observation Versus Irradiation For A Gross Totally Resected Grade II Meningioma Advanced 1. Alliance A (On Temporary Hold effective 02/15/2018) Phase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 Mutations 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors and diagnosis of lymphoma) 3. USO (PI Chung) (CRU only- Lisa or Marianne ) Phase I Trial utilizing Rova-T IV in DLL3 expressing solid tumors Brain Metastasis 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors and diagnosis of lymphoma) 11 BREAST CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Near Infrared Spectroscopy (NIRS) Near Infrared Spectroscopy (NIRS) as a method for measuring oxidative capacity of skeletal muscle mitochondria in cancer survivors (Breast Cancer only) 4. Body Composition Changes During Cancer Treatment Assessment of Body Composition During Cancer Treatment Using the SOZO Device 5. WISE- Walking Inspires Seniors Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 6. Body Composition Changes After Cancer Treatment Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

12 12 Cancer Control 1. Alliance A (Call Tranaka ) Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women 2. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 3. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors 4. WFU (Call Claudette ) A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors with Cognitive Impairment 5. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. 6. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) CCDR 1. WFU 30917CD (PI-Dr. Giguere) (Contact Jennifer Caldwell ) A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors Observational/Registry 1. USO POLARIS (PI- Dr Giguere) POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study (A ) Intervention/Prevention 1. Alliance A POSITIVE ((Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsive breast cancer) 2. Alliance A Randomized Phase Iii Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer 3. URCC (call Claudette ) Treatment of Refractory Nausea DCIS 1. Alliance Foundation AFT-25 (COMET) (PI-Dr. Giguere) Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial

13 New Diagnosis 1. WFU (PI-Dr. Giguere) (Call Claudette ) Understanding and Predicting Breast Cancer Events after Treatment (UPBEAT) Pre-Operative 1. Alliance A (Call Tranaka ) Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer Neo-Adjuvant 1. Alliance A (Temp hold effective 11/01/2018) Estrogen Receptor positive breast cancer NeoAdjuvant Treatment (ALTERNATE) in postmenopausal women Post-Neoadjuvant 1. NSABP B-51 Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neo adjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neo adjuvant Chemotherapy 2. Alliance A A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (ct1-3 N1)Who Have Positive Sentinel Lymph Node Disease After Neo- adjuvant Chemotherapy 3. CTSU EA1131 A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy 4. NSABP B-55 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy 5. SWOG 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 >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypn+) after Neoadjuvant Chemotherapy 6. NRG-BR005 A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery. 7. SWOG S1706 (PI- Dr. Zurenko) A Phase II Randomized Trial of Olaparib (NSC ) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer. 13

14 Adjuvant 1. NSABP B-55 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy 2. 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 3. Alliance A (ABC trial) A Randomized Phase Iii Double Blinded Placebo Controlled Trial Of Aspirin As Adjuvant Therapy For Her2 Negative Breast Cancer: The ABC Trial 4. Alliance A (PI= Dr. Giguere) Evaluation of Mammographic breast Density Effect of Aspirin: A Companion Study to alliance Study A Alliance A Randomized Phase Iii Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer. 6. WFU (PI-Dr. Giguere) (Call Claudette ) Understanding and Predicting Breast Cancer Events after Treatment (UPBEAT) 7. A (PI- Dr. Zurenko) Phase III Randomized Trial Of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction. 8. CTSU CCTG MA.39 (Tailor RT) (PI- Dr. Giguere) Tailor RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer 9. SWOG S1706 (PI- Dr. Zurenko) A Phase II Randomized Trial of Olaparib (NSC ) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer. Advanced/Metastatic 1. USO (INO-VT-464-CL-006) STAR TRIAL A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel plus Dexamethasone (SEVID) in Subjects with Advanced Breast Cancer Locally advanced 1. WFU (PI-Dr. Giguere) (Call Claudette ) Understanding and Predicting Breast Cancer Events after Treatment (UPBEAT) 2. Calithera CX (Temporary Hold effective 08/20/2018) A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Combination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non- African Ancestry 14

15 3. SWOG S1703 (Call Tranaka ) 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 15 1 st Line Metastatic 1. SWOG S1501 (Call Tranaka ) Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 3. Calithera CX (Temporary Hold effective 08/20/2018) A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Combination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non- African AncestryMolecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 4. SWOG S1703 (Call Tranaka ) 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 2 nd Line 1. USO STAR Trial (PI-TBD) Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) (ONT ) 2. SWOG S1416 Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation- Associated Breast Cancer. 3. SWOG S1501(Call Tranaka ) Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III 3 rd Line 1. USO STAR Trial (PI-TBD) Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) (ONT ) 2. Calithera CX (Temporary Hold effective 08/20/2018) A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Combination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non- African Ancestry.

16 4 th Line 1. USO STAR Trial (PI-TBD) Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) (ONT ) 16 CARCINOID/ NEUROENDOCRINE/ PNET CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors Advanced 1. CTSU EA2142 Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas 2. CTSU EA2161 Notify Anna when patient is identified. A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

17 3. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 4. Alliance A (PI= Dr. Giguere) Randomized, Double-Blinded Phase III Study Of Cabozantinib Versus Placebo In Patients With Advanced Neuroendocrine Tumors After Progression On Everolimus (CABINET) GASTROINTESTINAL COLORECTAL CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors 3. SWOG S0820 (Please call Tranaka Fuqua ) Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer or Rectal Cancer, Phase III Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) 2. EAQ162CD (call Jennifer Caldwell at ) Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent. 17

18 3. WFU 30917CD (PI-Dr. Giguere) (Contact Jennifer Caldwell ) A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors Intervention 1. URCC (call Claudette ) Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy New Diagnosis 1. SWOG S1417CD (call Jennifer Caldwell ) Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer. Pre-Operative: 1. NRG GI002 A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer Adjuvant 1. Alliance A 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 Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 2. SWOG S1417CD (call Jennifer Caldwell ) Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer. 3. Daiichi DS8201-A-J203 A Phase II Multicenter, Open-Label Study of DS-8201A in Subjects with HER2- Expressing Advanced Colorectal Cancer Metastatic- First line 1. NRG GI004 (COMMIT) Colorectal Cancer Metastatic dmmr Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mfolfox6/bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dmmr) Metastatic Colorectal Cancer Metastatic Second Line 1. AbbVie M Phase 2 Study Comparing Efficacy and Safety of ABT-165 plus FOLFIRI vs Bevacizumab plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine/Oxaliplatin and Bevacizumab ANAL 1. EA2165 (PI- Dr. Giguere) A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer 18

19 19 GASTRIC / GE JUNCTION CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer TreatmentAssessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) LIVER CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device

20 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 20 PANCREATIC CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

21 Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) Neo-adjuvant 1. Alliance A (Temp. hold effective 05/09/18) Preoperative Extended Chemotherapy Vs. Chemotherapy Plus Hypofractionated Radiation Therapy For Borderline Resectable Adenocarcinoma Of The Head Of The Pancreas Locally Advanced 1. RenovoRx TIGeR-PaC Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab- Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer Metastatic 1. CanStem111P A Phase III Study of BBI-608 plus nab-paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) GENITOURINARY CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 21

22 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) 22 GU: BLADDER (UROTHELIAL) BCG-Naïve High Grade 1. SWOG S1602 A Phase Iii Randomized Trial To Evaluate The Influence Of BCG Strain Differences And T Cell Priming With Intradermal BCG Before Intravesical Therapy For BCG-Naïve High- Grade Non-Muscle Invasive Bladder Cancer BCG-Unresponsive Recurrent 1. SWOG S1605 Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. Neo-adjuvant 1. Alliance A (PI= Giguere) A Phase II Study Of Dose-Dense Gemcitabine Plus Cisplatin (DDGC) In Patients With Muscle-Invasive Bladder Cancer With Bladder Preservation For Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations Locally Advanced: 1. Alliance A Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muscle invasive and locally advanced urothelial carcinoma (AMBASSADOR) Versus Observation 2. USO STAR (SGN22E-001) - OPEN at Eastside A Single-Arm, Open-Label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor (CPI) Therapy 3. Inovio UCa-001 (PI-Dr. Bolemon) (Cohort A and B open for full enrollment) An Open-Label, Multi-Center Trial of INO INO-9012 in Combination with Atezolizumab in Subjects with Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

23 Advanced/Metastatic 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 2. USO STAR (SGN22E-001) - OPEN at Eastside A Single-Arm, Open-Label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor (CPI) Therapy 3. Inovio UCa-001 (PI-Dr. Bolemon) (Cohort A and B open for full enrollment) An Open-Label, Multi-Center Trial of INO INO-9012 in Combination with Atezolizumab in Subjects with Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma GU: RENAL Peri-operative 1. CTSU EA8143 (PROSPER RCC) A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) Advanced 1. SWOG S1500 (Temporary Hold effective 12/05/18) A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET). 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) GU: PROSTATE CCDR 4. WFU 30917CD (PI-Dr. Giguere) (Contact Jennifer Caldwell ) A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors Adjuvant 1. NRG GU002 Phase II-III Trial Of Adjuvant Radiotherapy And Androgen Deprivation Following Radical Prostatectomy With Or Without Adjuvant Docetaxel Previously untreated localized adenocarcinoma of the prostate 1. NRG GU005 (PI-Dr.Zurenko) Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer Recurrent / Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 23

24 2. NRG GU006 (PI- Dr. Zurenko) A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial Of Salvage Radiotherapy With Or Without Enhanced Anti-Androgen Therapy With Apalutamide In Recurrent Prostate Cancer Metastatic disease 1. SWOG S1802 (PI-Dr. Giguere) Phase III Randomized Trial Of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery Or Radiation) Of The Primary Tumor In Metastatic Prostate Cancer GU: GERM CELL 1. COG AGCT 1531 A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors 2. Alliance A (PI Dr. Giguere) A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors. 24 GU: GYN CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

25 25 Cancer Control 1. URCC (Call Claudette ) A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Cancer: Reducing Chemotherapy Toxicity in Older Patients 2. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors 3. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. CERVICAL Cancer Control 1. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. CCDR 5. WFU 30917CD (PI-Dr. Giguere) (Contact Jennifer Caldwell ) A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors Adjuvant 1. RTOG R0724 Phase III Randomized Study of Concurrent Chemotherapy and Pelvic RT with or without Adjuvant Chemotherapy in High-risk Patients with Early Stage Cervical Cancer Following Radical Hysterectomy 2. GOG 0263 Randomized Phase III Clinical Trial of Adjuvant Radiation vs. Chemo-radiation in Intermediate Risk, Stage I/IIA, Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) ENDOMETRIAL (UTERINE) Cancer Control 1. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. CCDR 1. WFU 30917CD (PI-Dr. Giguere) (Contact Jennifer Caldwell ) A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors

26 Advanced/Persistent/Recurrent 1. GOG 0238 A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 3. GOG 3009 (ADXS ) PI-Dr. Elder Ph III Trial of ADXS11001 Administered Following Chemo-radiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer VULVAR Cancer Control 1. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. Advanced 1. GOG 0279 A Phase Ii Trial Evaluating Cisplatin And Gemcitabine Concurrent With Intensity- Modulated Radiation Therapy (IMRT) In The Treatment Of Locally Advanced Squamous Cell Carcinoma Of The Vulva 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) LEIOMYSARCOMA Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) 26 OVARIAN, FALLOPIAN TUMBE OR PRIMARY PERITONEAL Cancer Control 1. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. Newly Diagnosed 1. GOG 3015 Roche YO39523(Dr. Elder-PI) Phase III, Multi-center, Randomized, Study of Atezolizumab vs. Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly- Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

27 Advanced 1. Gradalis CL-PTL-126 (Open at FARIS only) Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecologic Cancers 2. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) Recurrent Platinum-resistant 1. GOG 3018 OVAL (VBL ) (PI Elder) STUDY TITLE: The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111)Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer VAGINAL Cancer Control 1. NRG-CC004 (call Claudette ) Phase II Double Blind Dose Finding Trial of Bupropion versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer. 27 HEAD AND NECK CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer TreatmentAssessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

28 Cancer Control 1. URCC (Call Claudette ) A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors 2. WFU (call Claudette ) A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) Adjuvant 1. RTOG 1216 (Temp Closed, may re-open 3 rd quarter 2017 Randomized Phase II/III Trial of Surgery and Post-operative Radiation Delivered with Concurrent Cisplatin vs. Docetaxel vs. Docetaxel and Cetuximab for High-risk Squamous Cell Cancer of the Head and Neck 2. NRG HN001 Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein-Barr Virus (EBV) Deoxyribonucleic Acid (DNA) 3. CTSU EA3132 Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) 28 Advanced 1. MATCH (EAY131) Master Protocol Molecular Analysis for Treatment Choice (Solid tumors or diagnosis of lymphoma) SALIVARY GLAND TUMORS 1. Mersana MER-XMT (CRU only) Phase 1B Dose Escalation/Expansion of XMT-1536 in solid tumors expressing NaPi2b (Salivary Duct) ( 2. RTOG 1008 A Randomized Phase Ii/Phase Iii Study Of Adjuvant Concurrent Radiation And Chemotherapy Versus Radiation Alone In Resected High-Risk Malignant Salivary Gland Tumors

29 29 HEMATOLOGIC CIOS 1. Moving On Effects of a 12-week Oncology Rehabilitation Program on Cardiorespiratory Fitness, Metabolic Fitness, Muscular Strength, Skeletal Muscle Mitochondrial Function and Body Composition in Cancer Survivors 2. GHS Cancer Institute Cancer Survivor Registry Database of cancer survivors at the GHS Cancer Institute. 3. Body Composition Changes During Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition During Cancer Treatment Using the SOZO Device 4. WISE- Walking Inspires Seniors (Call Ginny Simmons ) Physical activity study for patients who are not eligible for the Moving On program. The purpose is to explore the usefulness of using audiobooks to increase light-to-moderate intensity activity (primarily walking) over a 12-week intervention among older cancer survivors 5. Body Composition Changes After Cancer Treatment (Call Armand DeSollar ) Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device CCDR 1. WFU (WAYS) (call Claudette ) Work Ability in Young Adult Survivors (WAYS) HES 1. GSK-MHE Trial is Open to accrual, but please call research before approaching the patient. Very STRICT criteria (5/x enrolled) GRAFT-VERSUS-HOST DISEASE 1. Incyte INCB GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids for the Treatment of First Line Acute Graft-Versus-Host Disease 2. Incyte INCB MA-GD-301 (PI-Dr. Fanning) An Open-label, Expanded Access Program of Ruxolitinib for the Treatment of Graft vs. Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant. MDS 1. Onconova Phase III, International, Randomized, Control Study of Rigosertib vs. Physician s Choice of Treatment in Patients with MDS after Failure of a Hypermenthylating Agent