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, near activation, or temporarily closed. 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. The protocol list can be exported to an Excel or CSV file, or printed by selecting the arrow 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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110026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI27/48N/AINTERVENTION
210058LAO-TX035ETCTNGastrointestinal CancerActiveA Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the RectumI2/21N/AINTERVENTION
310075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid LeukemiaI9/48N/AINTERVENTION
410181LAO-NC010ETCTNGastrointestinal CancerActiveA Phase 2 Study of Savolitinib in Subjects with MET Amplified Metastatic Colorectal CancerII0/150SCREENING,INTERVENTION
510200LAO-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
610204LAO-TX035ETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveA Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)I0/312N/AINTERVENTION
710216LAO-OH007ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase I/II Study of AZD9291(Osimertinib) and CB-839 HCl in Patients with EGFR Mutant Non-Small Cell Lung CancerI/II0/18N/AINTERVENTION
810249LAO-MD017ETCTNMyelomaActiveMLN9708 (Ixazomib) and MLN4924 (Pevonedistat) in Relapsed/Refractory Multiple Myeloma Patients: A Phase 1b TrialI0/66N/AINTERVENTION
99767LAO-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 MutationII13/209N/AINTERVENTION
109837LAO-CA043ETCTNLung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic CancerActivePhase I Study of TRC102 in Combination with Cisplatin and Pemetrexed in Patients with Advanced Solid Tumors / Phase II Study of TRC102 with Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or CarboplatinI/II27/58N/AINTERVENTION
119910LAO-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 InhibitorI14/36N/AINTERVENTION
129938LAO-PA015ETCTNMiscellaneous and Metastatic CancerActivePhase I Clinical Trial of VX-970 in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid TumorsI25/51N/AINTERVENTION
139947LAO-CA043ETCTNUrothelial/ Bladder CancerActiveA Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or Without VX-970 in Metastatic Urothelial CarcinomaII78/90N/AINTERVENTION
14A021602ALLIANCENCTNEndocrine CancerActiveRandomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)III23/395N/AINTERVENTION
15CCTG CE.7CCTGNCTNMiscellaneous and Metastatic CancerActiveA Phase III Trial of Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain MetastasesIII11/206N/AINTERVENTION
16NRG-CC007CDNRGNCORPMale Reproductive System CancerActiveIncreasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation TherapyOther0/5040SCREENING,INTERVENTION
17NRG-GI002NRGNCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal CancerII363/348N/AINTERVENTION
18NRG-GU007NRGNCTNMale Reproductive System CancerActiveRandomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (with Initial Phase I)II0/36N/AINTERVENTION
19NRG-LU005NRGNCTNLung, Mediastinal, and Pleural CancerActiveLimited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus AtezolizumabII/III0/506N/AINTERVENTION
20RTOG-1112NRGNCTNGastrointestinal CancerActiveRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular CarcinomaIII177/368N/AINTERVENTION
21S0820SWOGNCORPGastrointestinal 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)III247/491N/AINTERVENTION
22S1415CDSWOGNCORPBreast 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)Other3234/3960N/AINTERVENTION
23S1600SWOGNCORPUrothelial/ Bladder CancerActiveA Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy OutcomesIII8/200N/AINTERVENTION
24S1607SWOGNCTNSkin 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 TherapyII20/64N/AINTERVENTION
2510017EDDO-NY158MISCELLANEOUSFemale Reproductive System CancerTemporarily Closed to AccrualA Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian CancerI/II12/75N/AINTERVENTION
2610056LAO-MN026ETCTNSoft Tissue Cancer/SarcomaActiveA Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue SarcomaII0/400SCREENING,INTERVENTION
2710057LAO-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 TumorsII37/68N/AINTERVENTION
2810089LAO-MN026ETCTNLymphomaActiveA Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell LymphomasII12/106N/AINTERVENTION
2910144LAO-NCIETCTNUrothelial/ Bladder CancerActiveA Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma with DNA-Repair DefectsII0/600SCREENING,INTERVENTION
3010212LAO-OH007ETCTNLeukemiaActiveA Phase 1b/2 Study of Pinometostat in Combination with Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia with MLL RearrangementI/II2/12N/AINTERVENTION
3110240LAO-OH007ETCTNEndocrine CancerActivePhase II Study of XL184 (Cabozantinib) in Combination with Nivolumab and Ipilimumab (CaboNivoIpi) in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted TherapyII0/27N/AINTERVENTION
3210246LAO-11030ETCTNLeukemiaActiveA Phase 1 Study of MLN4924 (Pevonedistat) and Belinostat in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic SyndromeI1/45N/AINTERVENTION
3310292LAO-NCIETCTNMiscellaneous and Metastatic CancerActiveDURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody MEDI4736 (Durvalumab) in Combination with Chemotherapy in Patients with Advanced Solid TumorsII1/115N/AINTERVENTION
349149LAO-NCIETCTNMiscellaneous and Metastatic CancerActiveMolecular Profiling-Based Assignment of Cancer Therapy for Patients with Advanced Solid TumorsII201/120207SCREENING,INTERVENTION
359673LAO-TX035ETCTNGastrointestinal CancerActiveA Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal CanalII78/139N/AINTERVENTION
369706EDDO-IL057MISCELLANEOUSLeukemiaActiveRandomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (REMAIN TRIAL)II77/80N/AINTERVENTION
379782LAO-NJ066ETCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase 1 Study of Talazoparib (BMN 673) in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid TumorsI43/66N/AINTERVENTION
389844LAO-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 TumorsI52/45N/AINTERVENTION
399875LAO-MA036ETCTNLymphomaActivePhase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCLII23/50N/AINTERVENTION
409876LAO-OH007ETCTNBreast CancerActivePhase 1b Study of HSP90 Inhibitor, AT13387 (Onalespib) in Combination with Paclitaxel in Patients with Advanced, Triple Negative Breast CancerI26/33N/AINTERVENTION
419881LAO-CT018ETCTNBreast Cancer;Gastrointestinal Cancer;Lung, Mediastinal, and Pleural CancerActiveA Phase 2 Study of Cediranib in Combination with Olaparib in Advanced Solid TumorsII116/126N/AINTERVENTION
42A011202ALLIANCENCTNBreast CancerTemporarily Closed to AccrualA Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant ChemotherapyIII1543/15763353SCREENING,INTERVENTION
43A021502ALLIANCENCTNGastrointestinal CancerActiveRandomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairIII201/700N/AINTERVENTION
44A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII55/324N/AINTERVENTION
45A051301ALLIANCENCTNLymphomaTemporarily 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
46A091802ALLIANCENCTNSkin CancerActivePhase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)II1/59N/AINTERVENTION
47A171601ALLIANCENCORPBreast CancerActiveA Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast CancerII40/88N/AINTERVENTION
48A191402CDALLIANCENCORPMale Reproductive System CancerActiveTesting Decision Aids to Improve Prostate Cancer Decisions for Minority MenIII157/172N/AINTERVENTION
49A221701ALLIANCENCORPMiscellaneous and Metastatic CancerActivePhase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment ApproachesIII7/279N/AINTERVENTION
50EA2161ECOG-ACRINNCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)II13/40N/AINTERVENTION