Adult Open Studies

Biology

LLUCC-BIOSPECIMEN LABORATORY - SPECIMEN COLLECTION
Loma Linda University Cancer Center Biospecimen Laboratory Specimen Collection Protocol
Mark E. Reeves, MD, PhD
Champions Oncology
Refer to separate attachment for list of "Tumors of High Interest"; this is included within the LLUCC Biospecimen Laboratory study above
Mark E. Reeves, MD, PhD

Breast

SWOG-NRG-BR009
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/ HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) 
 
Roshni Narurkar, MD, MBBS 
Syndevrx SDX-0103
A Phase 1b/2 Study Assessing The Safety And Efficacy of Evexomostat (Sdx-7320) In Combination With The Pi3kα Inhibitor alpelisib (Piqray®) Plus Fulvestrant In Postmenopausal Women At Risk For Hyperglycemia With Advanced Breast Cancer And A Pik3ca Mutation Who Have Progressed On Or Following Endocrine Therapy Plus A Cdk4/6 Inhibitor
Gayathri Nagaraj, MD
EMBER-4 E-Lilly – J2J-MC-JZLH
A Randomized, Open Label, Phase 3 Study of Adjuvant imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have previously received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2-Early Breast Cancer with an Increased Risk of Recurrence.
https://classic.clinicaltrials.gov/ct2/show/NCT05514054
Gayathri Nagaraj, MD
SWOG -S2212
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast (SCARLET), A Randomized Phase III Study  
https://classic.clinicaltrials.gov/ct2/show/NCT05929768
Gayathri Nagaraj, MD
TROPION-D926XC00001
A Phase 3 Open-label, Randomized Study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab Versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple-negative Breast Cancer who have residual invasive disease in the Breast and or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
https://clinicaltrials.gov/study/NCT05629585
Gayathi Nagaraj, MD

COVID-19

Statera BioPharma-ST205-101-002
Randomized, Single-Blind Study to Evaluate the Pharmacokinetics, Biomarkers, Safety and Tolerability of STAT-205 in Adult Patients with Mild COVID 19 Who Are at High Risk of Disease Progression
https://clinicaltrials.gov/ct2/show/NCT04708327
Jennifer Veltman, M.D.
 

Germ Cell

GI

Esophageal

Radiation Medicine
A phase II trial of proton-chemotherapy (PCT) for resectable esophageal or esophagogastric junction cancer
https://clinicaltrials.gov/ct2/show/NCT01684904
Gary Yang, MD

Pancreas

INV INT-Pancreatic - 5170277
A Phase II Trial of Pre-operative Chemotherapy (with Gemcitabine and Nab-paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients with Resectable Pancreatic Adenocarcinoma
https://www.clinicaltrials.gov/ct2/show/NCT03492671
Naveenraj Solomon, MD

Liver

Radiation Medicine
Phase I/II Trial of Stereotactic Body Proton Therapy (SBPT) for Patients with Liver Metastases 
https://clinicaltrials.gov/ct2/show/NCT01697371
Gary Yang, MD

Colon

Penn State-Colon Registry - 5180134
Prospective observational database of patients with colon cancer at risk of peritoneal recurrence
Michael O’Leary, MD

GU

Prostate

RADIATION MEDICINE
A prospective comparative study of outcomes with proton and photon radiation in prostate cancer (COMPPARE)
Jerry Slater, MD
JANSSEN
A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination with Cetrelimab versus Concurrent Chemoradiotherapy in Patients with Muscle-Invasive Urothelial Carcinoma of the Bladder who are not Receiving Radical Cystectomy. SunRise-2 Protocol 17000139BLC3001
https://classic.clinicaltrials.gov/ct2/show/NCT04658862
Brian Hu, MD

GYN

Ovarian/ Peritoneum

SWOG-NRG-GY019
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
https://www.clinicaltrials.gov/ct2/show/NCT04095364
Yevgeniya Ioffe, MD

Lung

ALLIANCE-A151216
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
https://clinicaltrials.gov/ct2/show/NCT02194738
Hamid Mirshahidi, MD

NSCLC

ECOG-ACRIN-E4512
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
https://clinicaltrials.gov/ct2/show/NCT02201992
Hamid Mirshahidi, MD

NSCLC

SWOG-S1914
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
https://clinicaltrials.gov/ct2/show/NCT04214262
Hamid Mirshahidi, MD

NSCLC

SWOG-LUNGMAP
A Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer
https://www.clinicaltrials.gov/ct2/show/NCT02154490
Hamid Mirshahidi, MD

LS-SCLC

Merck-MK-7339-013-02
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
https://clinicaltrials.gov/ct2/show/NCT04624204
Hamid Mirshahidi, MD

NSCLC

SWOG-A081801
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO
https://clinicaltrials.gov/ct2/show/NCT04267848
Hamid Mirshahidi, MD

NSCLC

SWOG-S2302
Summary: A Prospective Randomized Study of Ramucirumab (LY3009806: NSC#783608 + SBRT versus SBRT alone in High Risk, Early Stage NSCLC  https://clinicaltrials.gov/study/NCT05633602  
Hamid Mirshahidi, MD

Melanoma

Castle Biosciences-CBI-2019-SLNBprosp-001
DecisionDx-Melanoma Impact on Sentinel Lymph Node Biopsy Decisions and Clinical Outcomes DECIDE
https://clinicaltrials.gov/ct2/show/NCT02355587
Jukes Namm, MD

Multiple

COG-AGCT1532
A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with Intermediate and poor-risk metastatic germ cell tumors (Ages 26+ - Primary tumor arising in testis, ovary, retro-peritoneum or mediastinum)
Albert Kheradpour, MD

Solid Tumors

Apollomics-APL-101-01
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Hamid Mirshahidi, MD
AMGEN-20190135-H
A Phase 1b Study Evaluating the Safety, Tolerability and Efficacy of AMG 510 (pINN Sotorasib) in Combination with Panitumumab and FOLFIRI in Subjects with Advanced Solid Tumors with KRAS p.G12C Mutation (Codebreak 101 Subprotocol H)
https://clinicaltrials.gov/study/NCT04185883
Hamid Mirshahidi, MD

Transplant

PTLD

ATARA - ATA129-EBV-302
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
https://clinicaltrials.gov/ct2/show/NCT03394365
Dr. Sajad Khazal