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 or temporarily closed. Trial accrual is listed with the actual accrual over the total planned accrual and 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 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.

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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110061LAO-PA015ETCTNSolid TumorActiveA Phase 1 Study of Pembrolizumab (MK-3475) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI39/36N/AINTERVENTION
210146LAO-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 CancerII23/70N/AINTERVENTION
310186LAO-CT018ETCTNCNS Cancer (Primary tumor)Temporarily Closed to AccrualA Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed MeningiomaI/II22/38N/AINTERVENTION
410222LAO-CT018ETCTNGastrointestinal Cancer;Solid TumorTemporarily Closed to AccrualA Phase II Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid TumorsII24/50N/AINTERVENTION
510273LAO-CA043ETCTNLeukemiaActiveA Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid LeukemiaI18/48N/AINTERVENTION
610292LAO-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
710301LAO-CT018ETCTNMale Reproductive System CancerActiveA 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
810330LAO-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
910403LAO-MA036ETCTNFemale Reproductive System Cancer;Gastrointestinal Cancer;Solid TumorActivePhase 1 Trial of Gemcitabine Combined with the Elimusertib (BAY 1895344) ATR Inhibitor with Expansion Cohorts in Advanced Pancreatic and Ovarian CancerI11/64N/AINTERVENTION
1010504LAO-NCIETCTNSoft Tissue Cancer/SarcomaActiveA Randomized Phase 2 Study of Atezolizumab with or Without Selinexor in Alveolar Soft Part Sarcoma (AXIOM)II7/77N/AINTERVENTION
1110505LAO-CA043ETCTNCNS Cancer (Primary tumor)ActiveA Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent GlioblastomaI/II8/24N/AINTERVENTION
1210527LAO-MA036ETCTNSolid TumorTemporarily Closed to AccrualA Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination with the ATR Inhibitor M1774I0/66N/AINTERVENTION
1310572LAO-CT018ETCTNSolid TumorActiveA Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774I/IIN/A5SCREENING
1410579LAO-PA015ETCTNGastrointestinal Cancer;Solid TumorActivePhase I Trial of ZEN003694 (ZEN-3694) in Combination with Capecitabine in Patients with Solid TumorsI0/30N/AINTERVENTION
1510603LAO-MA036ETCTNMale Reproductive System CancerActiveA Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate CancerII0/17N/AINTERVENTION
16A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII209/352N/AINTERVENTION
17A021901ALLIANCENCTNEndocrine CancerActiveRandomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine TumorsII8/108N/AINTERVENTION
18A051902ALLIANCENCTNLymphomaActiveA Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell LymphomasII16/182N/AINTERVENTION
19A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII86/124448SCREENING, INTERVENTION
20A091903ALLIANCENCTNSkin CancerActiveA Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal MelanomaII27/99N/AINTERVENTION
21A092105ALLIANCENCTNHead and Neck CancerActiveRandomized Phase 2 Study of Nivolumab and Ipilimumab with or Without Cabozantinib in Patients with Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and ImmunotherapyII0/50N/AINTERVENTION
22A211801ALLIANCENCORPN/AActiveBRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline MutationIII23/300N/AINTERVENTION
23A212102ALLIANCENCORPMiscellaneous and Metastatic CancerActiveBlinded Reference Set For Multicancer Early Detection Blood TestsOtherN/AN/AOTHER
24ACCL1931COGNCORPMiscellaneous and Metastatic CancerActiveA Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia TherapyIII3/440N/AINTERVENTION
25AMC-112AMCMISCELLANEOUSAIDS-related Malignancy and ConditionTemporarily Closed to AccrualAxicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin LymphomaI0/200SCREENING, INTERVENTION
26AOST2032COGNCTNBone CancerTemporarily Closed to AccrualA Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed OsteosarcomaII/III10/528N/AINTERVENTION
27DCP-001DCPNCORPHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Solid TumorActiveUse of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)OtherN/AN/AOTHER
28EA1181ECOG-ACRINNCTNBreast CancerActiveEA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer)II2151/2156N/AINTERVENTION
29EA1211ECOG-ACRINNCTNBreast CancerActiveInterim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT TrialII1/235N/AINTERVENTION
30EA2174ECOG-ACRINNCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction AdenocarcinomaII/III275/278N/AINTERVENTION
31EA2176ECOG-ACRINNCTNGastrointestinal CancerActiveA Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naive Metastatic Anal Cancer PatientsIII141/205N/AINTERVENTION
32EA2192ECOG-ACRINNCTNGastrointestinal CancerActiveAPOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 MutationII43/152N/AINTERVENTION
33EA6141ECOG-ACRINNCTNSkin CancerActiveRandomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV MelanomaII/III445/601N/AINTERVENTION
34EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III80/200N/AINTERVENTION
35EA8192ECOG-ACRINNCTNUrothelial/ Bladder CancerActiveA Phase II/III Trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to NephroureterectomyII/III24/249N/AINTERVENTION
36EA8212ECOG-ACRINNCTNUrothelial/ Bladder CancerActiveA Randomized Phase III Trial of Intravesical BCG VeRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)III148/870N/AINTERVENTION
37EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III146/288N/AINTERVENTION
38EAQ211ECOG-ACRINNCORPLymphomaActiveSocial Genomic Mechanisms of Health Disparities among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin LymphomaOtherN/AN/AOTHER
39EAY191ECOG-ACRINNCTNLymphoma;Solid TumorActiveMolecular Analysis for Combination Therapy Choice (ComboMATCH)OtherN/A34SCREENING
40NRG-BR008NRGNCTNBreast CancerActiveA Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO)III3/1300N/AINTERVENTION
41NRG-GU012NRGNCTNKidney CancerActiveRandomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)II2/240N/AINTERVENTION
42NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI249/350N/AINTERVENTION
43S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII300/817321SCREENING, INTERVENTION
44S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII259/480N/AINTERVENTION
45S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII30/47N/AINTERVENTION
46S1937SWOGNCTNUrothelial/ Bladder CancerTemporarily Closed to AccrualA Phase III Randomized Trial of Eribulin (NSC #707389) with or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 TherapyIII23/465N/AINTERVENTION
47S2005SWOGNCTNLymphomaTemporarily Closed to AccrualA Phase II Randomized Study of Ibrutinib and Rituximab with or Without Venetoclax in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)II1/62N/AINTERVENTION
48S2012SWOGNCTNEndocrine CancerActiveRandomized Phase II/III Trial of First Line Platinum/Etoposide with or Without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)II/III24/189N/AINTERVENTION
49S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
50S2207SWOGNCTNLymphomaActiveRandomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapsed/Refractory Large B-Cell LymphomaII1/227N/AINTERVENTION