Protocol List

The Protocol List provides a listing of NCI clinical trials that are supported by the CTSU for which protocol documents are maintained on the CTSU members’ website. The trials on the list are either active or temporarily closed. Trial accrual is listed with the actual accrual over the total planned accrual and updated multiple times a day. The screening accrual column lists NA (Not Applicable) for studies that do not have a screening step. The list may be sorted by any topic in the header row (e.g., Protocol Number, Lead Organization, NIH Program, Status, or Phase) by clicking on a column header; click a second time to reverse the sort.

Phase:

*Some accruals have occurred outside of the CTSU systems and are collected manually, thus the total accrual number may not be accurate.

#Protocol
Number
Lead
Organization
NIH
Program
DiseaseStatusProtocol TitlePhaseActual/Planned Intervention AccrualScreening
Accrual
Step
Type(s)
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110057LAO-MA036ETCTNFemale Reproductive System Cancer;Lymphoma;Skin CancerTemporarily Closed to AccrualA Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin TumorsII55/68N/AINTERVENTION
210075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of KRT-232 (AMG-232) in Combination with Decitabine in Acute Myeloid LeukemiaI30/48N/AINTERVENTION
310170LAO-CT018ETCTNKidney Cancer;Solid TumorActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII18/60N/AINTERVENTION
410218LAO-MA036ETCTNCNS Cancer (Primary tumor)ActiveA Phase 1b Trial of Telaglenastat (CB-839) HCl in Combination with Radiation Therapy and Temozolomide in Patients with IDH-mutated Diffuse Astrocytoma and Anaplastic AstrocytomaI21/40N/AINTERVENTION
510219LAO-MA036ETCTNMyelomaActivePhase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor (CB-839 HCl) in Combination with Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple MyelomaI21/36N/AINTERVENTION
610300LAO-CT018ETCTNLeukemiaTemporarily Closed to AccrualBLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid LeukemiaII11/124N/AINTERVENTION
710301LAO-CT018ETCTNMale Reproductive System CancerActiveA Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, & Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)I/II9/24N/AINTERVENTION
810334LAO-CT018ETCTNLeukemiaTemporarily Closed to AccrualBLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive ChemotherapyII12/76N/AINTERVENTION
910387EDDO-NY313ETCTNAIDS-related Malignancy and Condition;Solid TumorActivePilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients with HIV InfectionI1/18N/AINTERVENTION
1010406LAO-PA015ETCTNGastrointestinal CancerActivePhase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination with FOLFIRI in GI Malignancies with a Focus on Metastatic Colorectal and Gastric/Gastroesophageal CancersI3/90N/AINTERVENTION
1110410LAO-11030ETCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase 1 Study of IPdR in Combination with Capecitabine and Radiotherapy in Rectal CancerI1/30N/AINTERVENTION
129892LAO-PA015ETCTNAIDS-related Malignancy and Condition;Female Reproductive System CancerActivePhase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination with Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal CancerI9/76N/AINTERVENTION
139938LAO-PA015ETCTNSolid TumorActivePhase I Clinical Trial of M6620 (VX-970, Berzosertib) in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid TumorsI51/66N/AINTERVENTION
14A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII73/352N/AINTERVENTION
15A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII233/341N/AINTERVENTION
16A041703ALLIANCENCTNLeukemiaActiveA Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory DiseaseII45/64N/AINTERVENTION
17A051902ALLIANCENCTNLymphomaActiveA Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell LymphomasII2/182N/AINTERVENTION
18A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII40/124328SCREENING, INTERVENTION
19A171901ALLIANCENCORPLung, Mediastinal, and Pleural CancerActiveOlder Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)II33/100N/AINTERVENTION
20A221702ALLIANCENCORPBreast CancerActiveARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence after Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection with and without Axillary Reverse MappingIII380/516N/AINTERVENTION
21AREN1721COGNCTNKidney CancerTemporarily Closed to AccrualA Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age GroupsII11/40N/AINTERVENTION
22DCP-001DCPNCORPHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Solid TumorActiveUse of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)OtherN/AN/AOTHER
23EA1181ECOG-ACRINNCTNBreast CancerActiveEA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer)II885/1250N/AINTERVENTION
24EA5163ECOG-ACRINNCTNLung, Mediastinal, and Pleural CancerActiveEA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven AnalysisIII371/846N/AINTERVENTION
25EA6141ECOG-ACRINNCTNSkin CancerActiveRandomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV MelanomaII/III303/600N/AINTERVENTION
26EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III49/200N/AINTERVENTION
27EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III91/288N/AINTERVENTION
28NCICOVIDNCINCIHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Solid TumorActiveNCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History StudyOtherN/A1592SCREENING, OTHER
29NRG-BR005NRGNCTNBreast CancerTemporarily Closed to AccrualA 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 SurgeryII105/175N/AINTERVENTION
30NRG-GY020NRGNCTNFemale Reproductive System CancerActiveA Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial CancerIII98/168N/AINTERVENTION
31NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI203/250N/AINTERVENTION
32PBTC-051PBTCMISCELLANEOUSCNS Cancer (Primary tumor)ActivePhase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem GliomaI25/45N/AINTERVENTION
33S0820SWOGNCORPGastrointestinal CancerActiveA Double Blind 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 or Rectal Cancer, Phase III- Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)III326/491N/AINTERVENTION
34S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII259/817276SCREENING, INTERVENTION
35S1712SWOGNCTNLeukemiaActiveA Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of DiseaseII62/84N/AINTERVENTION
36S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII65/480N/AINTERVENTION
37S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII17/47N/AINTERVENTION
38S1937SWOGNCTNUrothelial/ Bladder CancerActiveA Phase III Randomized Trial of Eribulin (NSC #707389) with or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyIII3/465N/AINTERVENTION
39S2012SWOGNCTNEndocrine CancerActiveRandomized Phase II/III Trial of First Line Platinum/Etoposide with or Without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)II/III0/189N/AINTERVENTION
40S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
4110026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI54/48N/AINTERVENTION
4210058LAO-TX035ETCTNGastrointestinal CancerActiveA Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the RectumI3/21N/AINTERVENTION
4310076LAO-TX035ETCTNMyelomaActiveA Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory MyelomaI13/40N/AINTERVENTION
4410150LAO-11030ETCTNFemale Reproductive System CancerActiveA Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian CancerI/II61/96N/AINTERVENTION
4510181LAO-NC010ETCTNGastrointestinal CancerActiveA Phase 2 Study of Savolitinib in Subjects with MET Amplified Metastatic Colorectal CancerII5/1570SCREENING, INTERVENTION
4610184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I3/34N/AINTERVENTION
4710208LAO-11030ETCTNGastrointestinal CancerActiveA Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic AdenocarcinomaI/II33/64337SCREENING, INTERVENTION
4810221LAO-TX035ETCTNSolid TumorActiveA Phase I/II Biomarker Driven Combination Trial of Copanlisib and Immune Checkpoint Inhibitors in Patients with Advanced Solid TumorsI/II34/102N/AINTERVENTION
4910268LAO-NCIETCTNEndocrine Cancer;Lung, Mediastinal, and Pleural CancerActiveRandomized Phase II Trial of Topotecan Plus M6620 (VX-970, Berzosertib) Vs. Topotecan Alone in Patients with Relapsed Small-Cell Lung CancerII80/98N/AINTERVENTION
5010272NCICCRMISCELLANEOUSMale Reproductive System CancerActiveA Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate CancerII136/200N/AINTERVENTION