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 TitlePhaseAccrual TargetAccrual Total
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1N0577ALLIANCENCTNCNS 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 GliomaIII361136
2RTOG-0724NRGNCTNFemale Reproductive System CancerActivePhase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical HysterectomyIII285182
3GOG-0263NRGNCTNFemale Reproductive System CancerActiveRandomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)III534289
49149LAO-NCIETCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualMolecular Profiling-Based Assignment of Cancer Therapy for Patients with Advanced Solid TumorsPilot180202
5A031102ALLIANCENCTNCNS Cancer (Primary tumor);Germ Cell CancerActiveA Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell TumorsIII420126
6A051301ALLIANCENCTNLymphomaTemporarily 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 SubtypeIII52632
7EA6134ECOG-ACRINNCTNSkin CancerActiveA Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant MelanomaIII300159
8S1416SWOGNCTNBreast CancerActivePhase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast CancerII333256
9NRG-GU002NRGNCTNMale Reproductive System CancerActivePhase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant DocetaxelII/III61256
109676LAO-MA036ETCTNFemale Reproductive System Cancer;Gastrointestinal Cancer;Kidney Cancer;Miscellaneous and Metastatic Cancer;Skin Cancer;Soft Tissue Cancer/SarcomaTemporarily Closed to AccrualA Phase 1 Trial of MK-3475 Plus Ziv-Aflibercept in Patients with Advanced Solid TumorsI7835
11NRG-BR002NRGNCTNMiscellaneous and Metastatic CancerActiveA Phase IIR/III Trial of Standard of Care Therapy with or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast CancerII/III36091
129591LAO-11030ETCTNMiscellaneous and Metastatic CancerActiveA Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients with Hepatic DysfunctionI6843
13EA1131ECOG-ACRINNCTNBreast CancerActiveA Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant ChemotherapyIII558192
149466LAO-MA036ETCTNMiscellaneous and Metastatic Cancer;Skin CancerActivePhase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I only)I/II500
15NRG-GU005NRGNCTNMale Reproductive System CancerActivePhase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate CancerIII60651
16A221505ALLIANCENCORPBreast CancerActivePhase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast ReconstructionIII88046
17S1613SWOGNCTNGastrointestinal CancerActiveA Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 AmplificationII1309
18S1612SWOGNCTNLeukemiaActiveA Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older (LEAP: Less-Intense AML Platform Trial)II/III167063
19NRG-GI004NRGNCTNGastrointestinal CancerActiveColorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal CancerIII34713
2010139LAO-MD017ETCTNGastrointestinal CancerActiveA Randomized Phase 2 Study of Atezolizumab in Combination with Cobimetinib Versus Atezolizumab Monotherapy in Participants with Unresectable CholangiocarcinomaII8276
21ACCL16N1CDCOGNCORPLeukemiaActiveDocumentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)Other27052
2210089LAO-MN026ETCTNLymphomaActiveA Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell LymphomasII1060
23A221504ALLIANCENCORPLung, Mediastinal, and Pleural CancerActiveA Randomized, Double-Blind, Placebo-Controlled Pilot of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)II2049
2410076LAO-TX035ETCTNMyelomaTemporarily Closed to AccrualA Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of AMG 232 in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory MyelomaI402
25S1619SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural MesotheliomaI244
26S1207SWOGNCTNBreast 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.III19001707
27NRG-GY006NRGNCTNFemale Reproductive System CancerActiveA Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal CancerII188143
289673LAO-TX035ETCTNGastrointestinal CancerActiveA Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal CanalII10039
299706EDDO-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)II8061
30EA3132ECOG-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 SequencingII34527
31NRG-HN004NRGNCTNHead and Neck CancerTemporarily Closed to AccrualRandomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to CisplatinII/III47410
3210066LAO-CT018ETCTNGastrointestinal CancerActiveA Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)I/II497
3310070LAO-MD017ETCTNLung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic CancerActivePhase 1/2 Study of Navitoclax Plus Vistusertib in Patients with Relapsed Small Cell Lung Cancer (SCLC) and Other Solid TumorsI/II244
3410132LAO-11030ETCTNFemale Reproductive System CancerActiveA Phase I Study of the Wee 1 Kinase (Wee 1) Inhibitor AZD1775 in Combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)I245
35CITN-13CITNMISCELLANEOUSLymphomaActiveA Phase II Trial of MK-3475 (Pembrolizumab) and Interferon Gamma 1-b Combination Immunotherapy in Patients with Previously Treated Mycosis Fungoides and Sezary SyndromeII309
3610075LAO-CA043ETCTNLeukemiaTemporarily Closed to AccrualA Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid LeukemiaI484
3710100LAO-CA043ETCTNUrothelial/ Bladder CancerActiveA Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Eribulin Mesylate in Combination with Atezolizumab Compared to Atezolizumab Alone in Subjects with Locally Advanced or Metastatic Transitional Cell Urothelial Cancer Where Platinum-Based Treatment is Not an OptionII781
38A091605ALLIANCENCTNSkin CancerActiveA Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell CarcinomaII1002
3910104LAO-11030ETCTNFemale Reproductive System CancerActiveA Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial CancerII8433
40A221101ALLIANCENCORPCNS Cancer (Primary tumor)ActiveA Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) To Reduce Cancer-Related Fatigue in Patients with High Grade GliomaIII330291
419672LAO-MA036ETCTNFemale Reproductive System CancerTemporarily Closed to AccrualA Phase 2 Study of Nivolumab and Ipilimumab in Advanced Leiomyosarcoma of the UterusII3720
429844LAO-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 TumorsI4535
439846LAO-NCIETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActivePatient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)Other50002204
44A061402ALLIANCENCTNMyelomaActiveSolitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation TherapyIII1109
45S1605SWOGNCTNUrothelial/ Bladder CancerActivePhase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder CancerII14877
469903LAO-MA036ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase 1B Study of AZD9291 in Combination with Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase InhibitorI5021
47S1702SWOGNCTNImmune Disorder (excluding AIDS and malignancy)ActiveA Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL AmyloidosisII395
4810129LAO-CT018ETCTNCNS Cancer (Primary tumor);Gastrointestinal Cancer;Miscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase 2 Study of the PARP Inhibitor Olaparib (AZD2281) in IDH1 and IDH2 Mutant Advanced Solid TumorsII1450
4910130LAO-11030ETCTNLymphoma;Miscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase I Study of Single Agent Tazemetostat in Subjects with Advanced Solid Tumors and B-Cell Lymphomas with Hepatic DysfunctionI660
5010131LAO-MD017ETCTNBreast Cancer;Male Reproductive System Cancer;Miscellaneous and Metastatic CancerActiveA Phase I Study of AZD8186 in Combination with Docetaxel in Patients with PTEN Mutated or PIK3CB Mutated Advanced Solid Tumors, Potentially Amenable to DocetaxelI580