Adult Oncology Clinical Trials

Her 2 Positive
NeoAdj/Adj HER2+ pts with Stage II or IIIA	The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 pCR: Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
ADJ HER2+ patients with residual disease after preoperative chemotherapy and HER2-directed therapy; >6 cycles pre or pre&post operatively.	The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib
Her 2 Negative
HR+/HER2- breast cancer after CDK4/6 and aromatase inhibitor treatment. Gedatolisib with fulvestrant or palbociclib.	A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of- Care Therapies in Patients with HR-Positive, HER2 Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy
Adjuvant therapy for ER+ HER2-positive early breast cancer: recruiting high-risk patients; considering those who decline Abemaciclib	A Phase III Randomized, Open-Label Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician's Choice if Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer - Medium risk cohor closed to accrual. High Risk Cohort Open only
Triple Negative
Three-arm plasma ctDNA-stratified research. Patients with persisting TNBC disease after pre-operative therapy will be randomly assigned to one of three arms based on plasma ctDNA positivity and genomic marker expression (s).	A Phase II circulating tumor DNA enriched, genomically directed postneoadjuvant trial for patients with residual triple negative breast cancer (PERSEVERE) -Suspended to Accrual As of 4/6/2023 Due to an updated risk in the new Atezolizumab IB v19, Indiana University is Temporarily Suspending the trial to accrual. Arm 1a: DNA Repair pathway = talazoparib + capecitabine Arm 1b: Immunotherapy pathway = atezolizumab + capecitabine Arm 1c: PI3K Pathway = inavolisib + capecitabine Arm 1d: DNA Repair + Immunotherapy = talazoparib + atezolizumab + capecitabine Arm 2: ctDNA positive but no actional target: Capecitabine or MD Choice Arm 3: ctDNA Negative: No Therapy, Capecitabine or MS Choice
Breast: Radiation
SRS with Olaparib and immunotherapy for triple-negative or BRCA-mutated breast cancer brain metastases.	Phase l/II Stereotactic radiosurgery with DDR inhibitor (Olaparib) followed by adjuvant durvalumab and chemotherapy in subjects with breast cancer brain metastases (SOLARA) - Temporarily Suspended second week of May •They accrued the third patient of Dose Level 2, waiting for them to get through their DLT period.
For pts with low-risk newly diagnosed invasive cancer treated with BCS or mastectomy with clear margins of excision. Patients with T3N0 disease are eligible.	CCTG MA.39: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Other
Oracle: ALL COMERS. Residual disease after completion of neoadjuvant chemotherapy	ORACLE: Observation of REsiduAl Cancer with Liquid biopsy Evaluation
Gene expression in breast cancer - FAU/MCI - Oncology Biorepository	A Grassroots Initiative to Increase Access to Care - Equitable Imaging and Diagnostics Testing Services (Community Foundation Broward Grant) - OPEN TO ACCRUAL

Adjuvant study for pts with completely resected St. IB- IIIA Non-Squamous NSCLC + adequate tissue for central review	Screening: ALCHEMIST: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial Stage 2A-3B (T3-4N2) Only
	ALK Pts: A Randomized Phase III Trial for Surgically Resected Early Stage NSCLC: Crizotinib vs. Observation for Patients with Tumors Harboring the ALK Fusion Protein
	Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO Must be EGFR (-) & ALK (-)
Pts with treatment-naïve unresectable, locally advanced, Stage III NSCLC	Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
1st Line NSCLC Non-Squamous or Squamous	A Phase 3, Open-Label, 3-Cohort Randomized Study of N-803 in Combination with Current Standard of Care vs. Standard of Care as First-Line Treatment for Patients with Advances or Metastatic Non-Small Cell Lung Cancer (NSCLC) Enrollment hold (pending development of Protocol Amendment)
Anti-PD-(L)1 Therapy with NSCLC as First-Line Therapy or Progressing on Single-Agent First-Line Anti-PD-(L)1	A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination with Anti-PD-(L)1 Therapy in Subjects with NSCLC as First-Line Therapy or When Progressing on Single-Agent First-Line Anti-PD- (L)1. Cohort B open only
2nd+ Line mets. NSCLC - Screening Protocol (pts. Can be screened at or before progression	A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer
2nd+ Line mets. NSCLC - Screening Protocol (pts. Can be screened at or before progression	S1900E - AMG 510 (KRAS G12C Mutated) S1800D - ALT 803 (Stage IV or Recurrent/Previously treated Anti-PD-1 or Anti-PD-L1) closed 03/10/2023 S1900F - Carboplatin/Pemetrexed w/wo Selpercatinib (Non-Squamous RET Fusion-Positive Stage IV)
Pleural effusion	Prospective Randomized Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
Metastic NSCLC & EGFR Mutation	A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, versus Aumolertinib with Chemotherapy, versus Osimertinib for Patients with Metastic NSCLC and an EGFR Mutation
Pts with New ≤ 30 mm benign pulmonary nodules.Full- transcriptome RNA sequencing test (Percepta Nasal Swab)	NIGHTINGALE: Clinical Utility of Management of Patients with CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Advanced Non-Small Cell Lung Cancer with a KRAS Mutation	A Phase 1 Study of the SHP2 Inhibitor bbp-3398 (formerly known as IACS-15509) in combination with the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer with a KRAS Mutation. SIV 04/17/2023 pending activation

Gastrointestinal (GI)

Pancreatic
Pancreatic Cancer Screening Registry	A Registry for Pancreatic Cancer Screening in Patients with Known Genetic Mutations or Familial History
Colon/Rectal
CRC- Adj Resected stage IIA rand to Tx vs. Surveillance using LUNAR assay	Phase II/III Study of Circulating tumor DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Genitourinary (GU)

Prostate
High Risk Metastatic Hormone Sensitive Prostate	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer (CYCLONE 3)

Radiation Oncology

Radiosurgery
Pts. With 5-15 brain mets from any primary	Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA- WBRT) Plus Memantine for 5-15 Brain Metastases
RAD ONC: Pts with First or second distant brain relapse(s) at least 8 weeks after upfront SRS and within 21 days prior to randomization	Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA- WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >= 4 Brain Metastases/Year
RAD ONC (Lung): Pts Stage I-IIA or limited T3N0M0 (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0)	A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Oral VMD-928; advanced solid tumors or lymphoma. TrkA protein overexpression, NTRK1 gene fusion, or NTRK1 mutation-related tumor progression after pan- Trk inhibitor treatment.	An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma
1st+ Line for pts wit loc. adv/mets solid tumors with ROS1, NTRK1/2/3 rearrangements. Prior chemo/IO allowed	A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1- 3 Rearrangements Enrollment will close for all ROS1 Cohorts (EXP-1, -2, -3, and -4). Acceptance of EXP-5 and EXP-6 NTRK Cohorts will continue
For patients with locally adv/mets. RET fusion +ve solid tumors that have progressed on standard tx. or no standard tx. exists	A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001) Open Cohorts: 1, 2, & 5 (RET fusion-positive solid tumors other than NSCLC or Thyroid)
Advanced Solid Tumors with KRAS p.G12C mutation	A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation
Oracle: ALL COMERS. Residual disease after completion of neoadjuvant chemotherapy	ORACLE: Observation of REsiduAl Cancer with Liquid biopsy Evaluation
Advanced Solid Tumors with ROR 2 expression	A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors
IgG1 monoclonal antibody (anti-CTLA4) TNBC, Pancreas, Melanoma, H&N, Ovarian, and other advanced solid tumors with detectable disease and no SOC alternatives	Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB Study
Advanced or metastatic NSCLC and other solid tumors. ROS1 fusion-positive	A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors. ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s)Temporary closure of Cohort 3
HBI-8000 30 mg oral BIW and/or nivolumab IV. Metastatic melanoma patients	Phase 3 study to compare the efficacy and safety of HBI- 8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma - Open Label Cohort for adult subjects with brain metastases is closed
Advanced Solid Tumors with a KRAS G12C mutation	Expanded access use of MRTX849 for the treatment of patients with advanced solid tumors with a Kras G12C mutation
Lung, melanoma, and colorectal cancer patients who receive SOC IO and SIGNATERA testing	BESPOKE Study of ctDNA Guided Immunotherapy - Enrollment On Hold as of 06APR2023
Pts with metastatic NSCLC or metastatic cutaneous melanoma	A Phase 2 Study of Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies after progression on prior PD-1 inhibitor Treatment
Monotherapy and in Combination with Pembrolizumab with Advanced, relapsed or refractory solid tumors	A Phase 1, Open-Label, Multicenter, Dose-Escalation, Dose-Expansion, and Dose-Randomization Study of IO- 108 as Monotherapy and in Combination with Pembrolizumab, in Adult Patients with Advanced Relapsed or Refractory Solid Tumors Pending activation
SRK-181 (TGFβ1 monoclonal antibody) administered alone and in combination with anti-PD-(L)1 therapy. (NSCLC), (UC), (MEL), (ccRCC) or other advanced or metastatic solid	A Phase 1, Open-Label, Dose-Escalation, and Dose- Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SRK-181 Administered Alone or In Combination with a Checkpoint Inhibitor in Patients with Locally Advanced or Metastatic Solid Tumors (DRAGON) - NEW STUDY

Hematology (HEME)

Lymphoma
Pts with R/R DLBCL or Car-T Therapy Eligible and transplant ineligible		A Phase 1B, Open-Label, Multicenter, Single Arm Study Evaluating The Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination with Rituximab plus Ifosfamide, Carboplatin Etoposite Phosphate in Patients with Relapsed/Refractory Transplant or Car-T Therapy Eligible Diffuse B-Cell Lymphoma
Epcoritamab for the treatment of R/R DLBCL and R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm		A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma Grade 1-3a When Administered in the Outpatient Setting
HIV+ patients with Stage II-IV CD20 +/- DLBCL; first-line treatment for dose-finding cohort; limited prior treatment for dose expansion cohort		A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDSRelated Lymphomas
2nd Line+ for Patients with Relapsed/Refractory DLBCL		A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzuman Vedotin in Combination with Rituximab plus Gemcitabine Plus Oxaliplatin (R-GEMOX) versus R_GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
3rd+ Line for Patients with Relapsed/Refractory CLL		A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia Richter's Transformation Cohort is open
Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) not Eligible for Intensive Induction Chemotherapy”		A Phase 1/2, Multicenter, Open-Label, Randomized, Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) not Eligible for Intensive Induction Chemotherapy
Loncastuximab Tesirine in combination with other anti-cancer treatments for recurrent or refractory B-cell non-Hodgkin lymphoma (DLBCL, HGBCL, FL, MCL, and MZL) (BL)		A Phase 1b Open-Label Study to Evaluate the Safety and Anti-Cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS 7)
Leukemia/MDS
Newly diagnosed precursor B-cell ALL		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 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL Temporary Closed to Accrual
Pts with previously untreated TP53 mutant AML		A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine versus Physician’s Choice of Venetoclax in Combination with Azacitidine or Intensive Chemotherapy in Previously Untreated Patients with TP53 Mutant Acute Myeloid Leukemia
Multiple Myeloma
Elranatamab - Relapsed/Refractory Multiple Myeloma - EAP		MAGNETISMM17: Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma - NEW STUDY
Other/Registry
CIBMTR BMT Registry		Protocol for a Research Database Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
CIBMTR Sample repository		Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Connect MDS/AML Registry		The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry AML, HR-MDS and ICUS cohorts are CLOSED