Protocol List

The Protocol List provides a listing of NCI clinical trials that are supported by the CTSU and are either active, near activation or temporarily closed. The list may be sorted by Protocol Number, Lead Organization, NIH Program, Status, or Phase. Clicking to the right of each title in the header row will display an arrow, an upwards facing arrow will sort by ascending order and a downwards facing arrow will display by descending order. Each protocol number is hyperlinked and clicking on the protocol number will open a new website, the National Cancer Institute’s Clinical Trials Physicians Data Query (PDQ®). PDQ provides additional information about each clinical trial including the trial summary, eligibility criteria and a listing of sites that have the trial open. The protocol list can be exported to and Excel or CSV file or printed by selecting the icon located above the header row.

*Some accruals have occurred outside of the CTSU systems and are collected manually, thus the total accrual number may not be accurate.
#Protocol NumberLead OrganizationNIH ProgramDiseaseStatusProtocol TitlePhaseActual/Planned Intervention AccrualScreening AccrualStep Type(s)
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110021LAO-MA036ETCTNGastrointestinal Cancer;Lung, Mediastinal, and Pleural CancerActiveA Phase 2 Study of MEDI4736 (Durvalumab) and Tremelimumab Alone or in Combination with High or Low-Dose Radiation in Metastatic Colorectal and NSCLCII109/180N/AINTERVENTION
210026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI22/48N/AINTERVENTION
310058LAO-TX035ETCTNGastrointestinal CancerActiveA Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the RectumI0/21N/AINTERVENTION
410075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid LeukemiaI8/48N/AINTERVENTION
510181LAO-NC010ETCTNGastrointestinal CancerActiveA Phase 2 Study of Savolitinib in Subjects with MET Amplified Metastatic Colorectal CancerII0/150SCREENING,INTERVENTION
610200LAO-MD017ETCTNLeukemiaActiveA Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination with Azacitidine in Patients with 11q23-Rearranged Acute Myeloid LeukemiaI/II0/48N/AINTERVENTION
79767LAO-CT018ETCTNUrothelial/ Bladder CancerActiveAn Open Label, Multicenter, Single Arm Phase II Study to Evaluate the Activity and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK-228), in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Whose Tumors Harbor a TSC1 and/or a TSC2 MutationII12/209N/AINTERVENTION
89910LAO-11030ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase 1 Trial of MLN0128 (TAK-228) in Combination with Osimertinib (AZD9291) in Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR Tyrosine Kinase InhibitorI13/36N/AINTERVENTION
99938LAO-PA015ETCTNMiscellaneous and Metastatic CancerActivePhase I Clinical Trial of VX-970 in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid TumorsI22/51N/AINTERVENTION
109947LAO-CA043ETCTNUrothelial/ Bladder CancerActiveA Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or Without VX-970 in Metastatic Urothelial CarcinomaII68/90N/AINTERVENTION
11A011106ALLIANCENCTNBreast CancerActiveALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III StudyIII1442/1475N/AINTERVENTION
12A021602ALLIANCENCTNEndocrine CancerActiveRandomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)III10/395N/AINTERVENTION
13CCTG CE.7CCTGNCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase III Trial of Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain MetastasesIII10/206N/AINTERVENTION
14NRG-GI002NRGNCTNGastrointestinal CancerActiveA Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal CancerII311/348N/AINTERVENTION
15RTOG-1112NRGNCTNGastrointestinal CancerActiveRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular CarcinomaIII166/368N/AINTERVENTION
16S0820SWOGNCORPGastrointestinal 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)III233/491N/AINTERVENTION
17S1207SWOGNCTNBreast CancerActivePhase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer. e^3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy.III1871/1900N/AINTERVENTION
18S1320SWOGNCTNSkin CancerActiveA Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma II243/280N/AINTERVENTION
19S1415CDSWOGNCORPBreast Cancer;Gastrointestinal Cancer;Lung, Mediastinal, and Pleural CancerActiveA Pragmatic Trial to Evaluate a Guideline Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)Other2812/3960N/AINTERVENTION
20S1512SWOGNCTNSkin CancerActive A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)II21/77N/AINTERVENTION
21S1600SWOGNCORPUrothelial/ Bladder CancerActiveA Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy OutcomesIII1/200N/AINTERVENTION
22S1607SWOGNCTNSkin CancerActiveA Phase II Study of Combining Talimogene Laherparepvec T-VEC (NSC-785349) and MK-3475 (Pembrolizumab) (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based TherapyII13/64N/AINTERVENTION
2310056LAO-MN026ETCTNSoft Tissue Cancer/SarcomaActiveA Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue SarcomaII0/400SCREENING,INTERVENTION
2410057LAO-NJ066ETCTNFemale Reproductive System Cancer;Lymphoma;Skin CancerActiveA 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 TumorsII36/68N/AINTERVENTION
2510089LAO-MN026ETCTNLymphomaActiveA Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell LymphomasII5/106N/AINTERVENTION
2610144LAO-NCIETCTNUrothelial/ Bladder CancerActiveA Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma with DNA-Repair DefectsII0/600SCREENING,INTERVENTION
2710146LAO-NC010ETCTNBreast CancerActiveRandomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Neoantigen Vaccine Vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) in Patients with Metastatic Triple Negative Breast CancerII0/70N/AINTERVENTION
2810212LAO-OH007ETCTNLeukemiaActiveA Phase 1b/2 Study of Pinometostat in Combination with Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia with MLL RearrangementI/II0/12N/AINTERVENTION
299673LAO-TX035ETCTNGastrointestinal CancerActiveA Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal CanalII69/100N/AINTERVENTION
309782LAO-NJ066ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1 Study of Talazoparib (BMN 673) in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid TumorsI43/66N/AINTERVENTION
319844LAO-MD017ETCTNBreast Cancer;Miscellaneous and Metastatic CancerActiveA Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab with or Without Ipilimumab in Advanced Solid TumorsI46/45N/AINTERVENTION
329875LAO-MA036ETCTNLymphomaActivePhase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCLII22/50N/AINTERVENTION
339876LAO-OH007ETCTNBreast CancerActivePhase 1b Study of HSP90 Inhibitor, AT13387 in Combination with Paclitaxel in Patients with Advanced, Triple Negative Breast CancerI24/33N/AINTERVENTION
349881LAO-CT018ETCTNBreast Cancer;Gastrointestinal Cancer;Lung, Mediastinal, and Pleural CancerActiveA Phase 2 Study of Cediranib in Combination with Olaparib in Advanced Solid TumorsII111/126N/AINTERVENTION
359979LAO-MN026ETCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualPhase 1 and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2-Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Brain MetastasesI6/47N/AINTERVENTION
36A021502ALLIANCENCTNGastrointestinal CancerActiveRandomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairIII165/700N/AINTERVENTION
37A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII35/324N/AINTERVENTION
38A041701ALLIANCENCTNLeukemiaActiveA Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction ChemotherapyII/III0/670N/AINTERVENTION
39A051301ALLIANCENCTNLymphomaTemporarily Closed to AccrualA Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell SubtypeIII34/296254SCREENING,INTERVENTION
40A191402CDALLIANCENCORPMale Reproductive System CancerActiveTesting Decision Aids to Improve Prostate Cancer Decisions for Minority MenIII148/172N/AINTERVENTION
41A221701ALLIANCENCORPMiscellaneous and Metastatic CancerActivePhase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment ApproachesIII0/279N/AINTERVENTION
42EA2161ECOG-ACRINNCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)II13/40N/AINTERVENTION
43EA3132ECOG-ACRINNCTNHead and Neck CancerActivePhase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 SequencingII46/345N/AINTERVENTION
44EA5163ECOG-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 AnalysisIII0/846N/AINTERVENTION
45EA6141ECOG-ACRINNCTNSkin CancerTemporarily Closed to AccrualRandomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV MelanomaII/III250/400N/AINTERVENTION
46EA9161ECOG-ACRINNCTNLeukemiaActiveA Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)III16/720N/AINTERVENTION
47N0577ALLIANCENCTNCNS Cancer (Primary tumor)ActiveN0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade GliomaIII152/361254SCREENING,INTERVENTION
48NHLBI-MDSECOG-ACRINNCORPLeukemiaActiveThe National Myelodysplastic Syndromes (MDS) StudyOtherN/AN/AOTHER
49NRG-GU006NRGNCTNMale Reproductive System CancerActiveA Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate CancerII64/324N/AINTERVENTION
50RTOG-1119NRGNCTNBreast CancerActivePhase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination with Concurrent Lapatinib in Patients with Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROGII137/143N/AINTERVENTION