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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110013LAO-NC010ETCTNBreast CancerTemporarily Closed to AccrualRandomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, with or Without Atezolizumab in Triple Negative Breast Cancer (TNBC)II67/72N/AINTERVENTION
210014LAO-11030ETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveA Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumor MalignanciesPilot17/40N/AINTERVENTION
310017EDDO-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
410020LAO-CT018ETCTNBreast CancerActiveA Phase II Open-Label, Randomized Study of PARP Inhibition (Olaparib) Either Alone or in Combination with Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) in Homologous DNA Repair (HDR) Deficient, Locally Advanced or Metastatic Non-HER2-Positive Breast CancerII41/90N/AINTERVENTION
510066LAO-CT018ETCTNGastrointestinal CancerActiveA Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)I/II22/49N/AINTERVENTION
610104LAO-11030ETCTNFemale Reproductive System CancerActiveA Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial CancerII82/84N/AINTERVENTION
710106LAO-MD017ETCTNLymphomaActiveA Phase I and Randomized Phase II Study of KW-0761 (Mogamulizumab) and MK-3475 (Pembrolizumab) in Relapsed and Refractory LymphomasI/II4/76N/AINTERVENTION
810150LAO-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/II15/96N/AINTERVENTION
910200LAO-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
1010216LAO-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
1110231DCTDNCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualNCORP Tissue Procurement Protocol: An NCI Cancer Moonshot StudyPilotN/AN/AOTHER
129974LAO-MA036ETCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Phase II Study of Olaparib Plus Cediranib in Combination with Standard Therapy for Small Cell Lung CancerII9/132N/AINTERVENTION
139979LAO-MN026ETCTNMiscellaneous and Metastatic CancerActivePhase 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
14A031102ALLIANCENCTNCNS 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 TumorsIII217/420N/AINTERVENTION
15A031704ALLIANCENCTNKidney CancerActivePD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]III17/1046N/AINTERVENTION
16A191402CDALLIANCENCORPMale Reproductive System CancerActiveTesting Decision Aids to Improve Prostate Cancer Decisions for Minority MenIII158/172N/AINTERVENTION
17A211401ALLIANCENCORPLung, Mediastinal, and Pleural CancerActiveReducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke CigarettesIII16/783N/AINTERVENTION
18A211601ALLIANCENCORPBreast CancerActiveEvaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502IIIN/AN/AOTHER
19ACCL16N1CDCOGNCORPLeukemiaActiveDocumentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)OtherN/AN/AOTHER
20EA6141ECOG-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
21EA6174ECOG-ACRINNCTNSkin CancerActiveSTAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III TrialIII21/500N/AINTERVENTION
22EA8143ECOG-ACRINNCTNKidney CancerActiveA Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)III290/766337SCREENING,INTERVENTION
23EA8171ECOG-ACRINNCTNMale Reproductive System CancerActiveMultiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate CancerII46/852N/AINTERVENTION
24EA9131ECOG-ACRINNCORPLeukemiaActiveA Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)II119/200N/AINTERVENTION
25EAE161ECOG-ACRINNCTNFemale Reproductive System CancerTemporarily Closed to AccrualPerfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab and Paclitaxel Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal CarcinomaII1/1843SCREENING,INTERVENTION
26EAI142ECOG-ACRINNCTNBreast CancerActive[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast CancerII62/99N/AINTERVENTION
27NRG-BR002NRGNCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualA 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/III129/360N/AINTERVENTION
28NRG-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 CancerII165/324N/AINTERVENTION
29NSABP-B-51NRGNCTNBreast CancerActiveA Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant ChemotherapyIII1341/1636N/AINTERVENTION
30RTOG-1112NRGNCTNGastrointestinal CancerActiveRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular CarcinomaIII180/368N/AINTERVENTION
31S1415CDSWOGNCORPBreast 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)Other3434/3960N/AINTERVENTION
32S1512SWOGNCTNSkin CancerActiveA Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)II28/56N/AINTERVENTION
33S1826SWOGNCTNLymphomaActiveA Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin LymphomaIII5/987N/AINTERVENTION
3410015EDDO-MI014MISCELLANEOUSSoft Tissue Cancer/SarcomaActiveA Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid HemangioendotheliomaII41/29N/AINTERVENTION
3510057LAO-NJ066ETCTNFemale 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 TumorsII38/68N/AINTERVENTION
3610061LAO-PA015ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI14/36N/AINTERVENTION
3710070LAO-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/II11/24N/AINTERVENTION
3810075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid LeukemiaI12/48N/AINTERVENTION
3910096LAO-CT018ETCTNMale Reproductive System CancerActiveA Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE)I/II5/18N/AINTERVENTION
4010145LAO-NCIETCTNLymphoma;Miscellaneous and Metastatic CancerActivePhase Ib Combination Study of Copanlisib and Nivolumab in Advanced Solid Tumors and LymphomasI20/41N/AINTERVENTION
4110146LAO-NC010ETCTNBreast CancerTemporarily Closed to AccrualRandomized 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
4210166LAO-MD017ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung CancerII5/24N/AINTERVENTION
4310170LAO-CT018ETCTNKidney Cancer;Miscellaneous and Metastatic CancerActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII5/60N/AINTERVENTION
4410217LAO-TX035ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients with Advanced Solid TumorsI0/102N/AINTERVENTION
459844LAO-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 TumorsI56/45N/AINTERVENTION
469924LAO-CA043ETCTNLymphomaActiveA Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)I19/44N/AINTERVENTION
47A021502ALLIANCENCTNGastrointestinal CancerActiveRandomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairIII221/700N/AINTERVENTION
48A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII70/324N/AINTERVENTION
49A071401ALLIANCENCTNCNS Cancer (Primary tumor)Temporarily Closed to AccrualPhase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 MutationsII40/124322SCREENING,INTERVENTION
50A171601ALLIANCENCORPBreast 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 CancerII51/88N/AINTERVENTION