Protocol List

The Protocol List provides a listing of NCI clinical trials supported by the CTSU and generally open to cross-organizational participation. 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 is 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 filtered using the filters available on the page or sorted by any topic in the header row 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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110146LAO-CT018ETCTNBreast CancerActiveRandomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients with Metastatic Triple Negative Breast CancerII27/70N/AINTERVENTION
210222LAO-CT018ETCTNGastrointestinal Cancer;Solid TumorTemporarily Closed to AccrualA Phase II Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid TumorsII24/50N/AINTERVENTION
310273LAO-CA043ETCTNLeukemiaActiveA Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid LeukemiaI24/48N/AINTERVENTION
410292LAO-NCIETCTNSolid TumorActiveDURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody Durvalumab in Combination with Chemotherapy in Patients with Advanced Solid TumorsII73/115N/AINTERVENTION
510330LAO-CT018ETCTNBone CancerTemporarily Closed to AccrualA Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional ChondrosarcomaII19/32N/AINTERVENTION
610504LAO-NCIETCTNSoft Tissue Cancer/SarcomaActiveA Randomized Phase 2 Study of Atezolizumab with or Without Selinexor in Alveolar Soft Part Sarcoma (AXIOM)II8/77N/AINTERVENTION
710505LAO-CA043ETCTNCNS Cancer (Primary tumor)ActiveA Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent GlioblastomaI/II12/24N/AINTERVENTION
810507LAO-MA036ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination with Etoposide/Platinum in Patients with NUT CarcinomaI/II12/18N/AINTERVENTION
910579LAO-PA015ETCTNGastrointestinal Cancer;Solid TumorActivePhase I Trial of ZEN003694 (ZEN-3694) in Combination with Capecitabine in Patients with Solid TumorsI4/30N/AINTERVENTION
1010603LAO-MA036ETCTNMale Reproductive System CancerActiveA Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate CancerII2/17N/AINTERVENTION
1110612LAO-CT018ETCTNMyelomaActiveA Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple MyelomaII0/70N/AINTERVENTION
1210324LAO-MD017ETCTNFemale Reproductive System CancerActiveA Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) with Peposertib (M3814) in Platinum - Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)I50/49N/AINTERVENTION
1310327LAO-CA043ETCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Phase I Trial of MLN0128 (Sapanisertib) and Telaglenastat (CB-839) HCL in Advanced NSCLC PatientsI18/85N/AINTERVENTION
1410335LAO-CT018ETCTNLeukemia;LymphomaActiveA Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)I10/30N/AINTERVENTION
1510487LAO-MD017ETCTNMale Reproductive System CancerActiveA Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer with Neuroendocrine DifferentiationII4/30N/AINTERVENTION
1610496LAO-CA043ETCTNHead and Neck CancerActiveA Phase 2 Study of Ipatasertib in Combination with Pembrolizumab for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and NeckII24/52N/AINTERVENTION
1710508LAO-MA036ETCTNLymphomaActiveA Phase 1 Study of Nivolumab in Combination with ASTX727 in B-cell Lymphoma (NHL or HL) with an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)I8/27N/AINTERVENTION
1810546LAO-MA036ETCTNBreast CancerActivePhase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast CancerI6/24N/AINTERVENTION
1910558LAO-OH007ETCTNEndocrine CancerActiveA Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine TumorsII21/94N/AINTERVENTION
2010559LAO-11030ETCTNCNS Cancer (Primary tumor)ActiveA Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene FusionII1/35N/AINTERVENTION
2110561LAO-NCIETCTNSolid TumorActiveRapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 3 Tiragolumab + AtezolizumabII4/15N/AINTERVENTION
2210346LAO-NCIETCTNSolid TumorActivePilot Study of DS-8201a Pharmacodynamics in Patients with HER2-Expressing Advanced Solid TumorsI62/55N/AINTERVENTION
2310434LAO-OH007ETCTNLeukemiaActiveRandomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML with MDS-Related ChangesII24/78N/AINTERVENTION
2410464EDDO-MI014ETCTNGastrointestinal CancerActiveA Phase 1 Study of Olaparib in Combination with Durvalumab (MEDI4736) and Concurrent Radiation Therapy Following First-Line Chemotherapy in Locally Advanced Unresectable Pancreatic CancerI6/18N/AINTERVENTION
2510483LAO-11030ETCTNUrothelial/ Bladder CancerActivePhase Ib Trial of Erdafitinib Combined with Enfortumab Vedotin Following Platinum and PD1/L1 Inhibitors for Metastatic Urothelial Carcinoma with FGFR2/3 Genetic AlterationsI9/30N/AINTERVENTION
2610528LAO-MA036ETCTNSolid TumorTemporarily Closed to AccrualA Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid TumorsI1/30N/AINTERVENTION
2710553LAO-MD017ETCTNHead and Neck CancerActiveA Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland CancerII3/20N/AINTERVENTION
2810572LAO-CT018ETCTNSolid TumorActiveA Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774I/II4/4242SCREENING, INTERVENTION
2910355LAO-MA036ETCTNFemale Reproductive System Cancer;Solid TumorActiveA Phase I Study of DS-8201a in Combination with Olaparib in HER2-Expressing MalignanciesI27/55N/AINTERVENTION
3010366LAO-MD017ETCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase 1/2 Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic AdenocarcinomaI/II19/24N/AINTERVENTION
3110479LAO-CT018ETCTNEndocrine CancerActiveA Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine TumorsI0/24N/AINTERVENTION
3210551LAO-PA015ETCTNBreast Cancer;Male Reproductive System Cancer;Solid TumorTemporarily Closed to AccrualA Phase I/Ib Study of Anti-CD47 Hu5F9-G4 (Magrolimab) in Combination with Olaparib in Patients with BRCA1/2-Mutant TumorsI0/33N/AINTERVENTION
3310601LAO-CA043ETCTNLymphomaActiveA Phase 1 Study of Mosunetuzumab with Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)I0/30N/AINTERVENTION
349846LAO-NCIETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Solid TumorActivePatient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)OtherN/AN/AOTHER
3510075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of KRT-232 (AMG-232) in Combination with Decitabine and Venetoclax in Acute Myeloid LeukemiaI35/48N/AINTERVENTION
3610144LAO-NCIETCTNEndocrine Cancer;Germ Cell Cancer;Kidney Cancer;Male Reproductive System Cancer;Urothelial/ Bladder CancerActiveA Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma and Other Genitourinary Tumors with DNA-Repair DefectsII20/6033SCREENING, INTERVENTION
3710204LAO-TX035ETCTNFemale Reproductive System Cancer;Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Kidney Cancer;Lung, Mediastinal, and Pleural Cancer;Lymphoma;Skin Cancer;Solid Tumor;Urothelial/ Bladder CancerActiveA Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)I69/312N/AINTERVENTION
3810285LAO-CT018ETCTNSkin CancerActivePhase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor TherapyI/II12/18N/AINTERVENTION
3910300LAO-CT018ETCTNLeukemiaActiveBLockade 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 LeukemiaII41/124N/AINTERVENTION
4010301LAO-CT018ETCTNMale Reproductive System CancerTemporarily Closed to AccrualA Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, & Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)I/II15/24N/AINTERVENTION
4110302LAO-CA043ETCTNBreast CancerActivePhase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast CancerII64/70N/AINTERVENTION
4210347LAO-CT018ETCTNLymphomaActiveA Phase I Study with an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and S├ęzary Syndrome (SS)I14/33N/AINTERVENTION
4310371LAO-NCIETCTNBreast Cancer;Female Reproductive System Cancer;Gastrointestinal Cancer;Male Reproductive System Cancer;Solid TumorActiveA Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients with Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage ResponseII24/36N/AINTERVENTION
4410449LAO-TX035ETCTNBreast Cancer;Solid TumorActiveA Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast CancerI9/30N/AINTERVENTION
4510466LAO-NCIETCTNKidney CancerActiveA Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects with Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell CancerII12/4212SCREENING, INTERVENTION
4610486LAO-TX035ETCTNSolid TumorActivePhase 2 Trial of the Combination of the BET Inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET)II14/88N/AINTERVENTION
4710499LAO-CT018ETCTNGastrointestinal Cancer;Lymphoma;Solid TumorActivePhase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors and LymphomasI/II12/30N/AINTERVENTION
4810525LAO-MA036ETCTNBreast CancerActiveA Phase 1b Trial of ZEN003694 (ZEN-3694) with Pembrolizumab and Nab-Paclitaxel in Patients with Metastatic Triple-Negative Breast CancerI6/57N/AINTERVENTION
4910605LAO-TX035ETCTNGastrointestinal CancerActiveA Phase 1 Study of ZEN003694 (ZEN-3694) in Combination with Cetuximab and Encorafenib in Patients with Refractory BRAF V600E Metastatic Colorectal CancerI0/30N/AINTERVENTION
5010096LAO-CT018ETCTNMale Reproductive System CancerTemporarily Closed to AccrualA Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE)I/II145/100N/AINTERVENTION