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 TumorsI21/36N/AINTERVENTION
210144LAO-NCIETCTNEndocrine Cancer;Kidney Cancer;Male Reproductive System Cancer;Urothelial/ Bladder CancerActiveA Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma with DNA-Repair DefectsII4/605SCREENING, INTERVENTION
310273LAO-CA043ETCTNLeukemiaActiveA Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid LeukemiaI14/48N/AINTERVENTION
410301LAO-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/II9/24N/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
610387EDDO-NY313ETCTNAIDS-related Malignancy and Condition;Solid TumorActivePilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients with HIV InfectionI2/18N/AINTERVENTION
710404LAO-CA043ETCTNSolid Tumor;Urothelial/ Bladder CancerTemporarily Closed to AccrualA Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination with Cisplatin and with Cisplatin Plus Gemcitabine in Advanced Solid Tumors with an Emphasis on Urothelial CarcinomaI7/74N/AINTERVENTION
810406LAO-PA015ETCTNGastrointestinal CancerActivePhase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination with FOLFIRI in GI Malignancies with a Focus on Metastatic Colorectal and Gastric/Gastroesophageal CancersI6/90N/AINTERVENTION
910504LAO-NCIETCTNSoft Tissue Cancer/SarcomaActiveA Randomized Phase 2 Study of Atezolizumab with or Without Selinexor in Alveolar Soft Part Sarcoma (AXIOM)II0/77N/AINTERVENTION
1010507LAO-MA036ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination with Etoposide/Platinum in Patients with NUT CarcinomaI/II0/18N/AINTERVENTION
119892LAO-PA015ETCTNAIDS-related Malignancy and Condition;Female Reproductive System CancerActivePhase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination with Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal CancerI11/76N/AINTERVENTION
129938LAO-PA015ETCTNSolid TumorActivePhase I Clinical Trial of M6620 (VX-970, Berzosertib) in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid TumorsI64/66N/AINTERVENTION
13A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII107/352N/AINTERVENTION
14A041703ALLIANCENCTNLeukemiaActiveA Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory DiseaseII47/64N/AINTERVENTION
15A051902ALLIANCENCTNLymphomaActiveA 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 LymphomasII7/182N/AINTERVENTION
16A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII57/124370SCREENING, INTERVENTION
17A171901ALLIANCENCORPLung, Mediastinal, and Pleural CancerActiveOlder Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)II61/100N/AINTERVENTION
18A211801ALLIANCENCORPN/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 MutationIII0/300N/AINTERVENTION
19A221702ALLIANCENCORPBreast CancerActiveARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence after Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection with and without Axillary Reverse MappingIII500/516N/AINTERVENTION
20DCP-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
21EA1181ECOG-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)II1320/2156N/AINTERVENTION
22EA2192ECOG-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 MutationII20/152N/AINTERVENTION
23EA5163ECOG-ACRINNCTNLung, Mediastinal, and Pleural CancerActiveEA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven AnalysisIII420/846N/AINTERVENTION
24EA6141ECOG-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/III336/600N/AINTERVENTION
25EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III51/200N/AINTERVENTION
26EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III105/288N/AINTERVENTION
27NRG-BR005NRGNCTNBreast CancerTemporarily Closed to AccrualA Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without SurgeryII105/175N/AINTERVENTION
28NRG-GY014NRGNCTNFemale Reproductive System CancerActiveA Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial AdenocarcinomaII57/63N/AINTERVENTION
29NRG-GY020NRGNCTNFemale Reproductive System CancerActiveA Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial CancerIII131/168N/AINTERVENTION
30NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI221/250N/AINTERVENTION
31PBTC-051PBTCMISCELLANEOUSCNS Cancer (Primary tumor)ActivePhase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem GliomaI28/45N/AINTERVENTION
32S0820SWOGNCORPGastrointestinal 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)III334/491N/AINTERVENTION
33S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII271/817289SCREENING, INTERVENTION
34S1712SWOGNCTNLeukemiaActiveA Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of DiseaseII76/84N/AINTERVENTION
35S1905SWOGNCTNLeukemia;LymphomaTemporarily Closed to AccrualA Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)I/II10/64N/AINTERVENTION
36S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII102/480N/AINTERVENTION
37S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII22/47N/AINTERVENTION
38S1937SWOGNCTNUrothelial/ Bladder CancerActiveA 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 TherapyIII9/465N/AINTERVENTION
39S2005SWOGNCTNLymphomaTemporarily 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)II1/71N/AINTERVENTION
40S2012SWOGNCTNEndocrine 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/III0/189N/AINTERVENTION
41S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
4210020LAO-CT018ETCTNBreast CancerTemporarily Closed to AccrualA 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 CancerII93/94N/AINTERVENTION
4310026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI54/48N/AINTERVENTION
4410076LAO-TX035ETCTNMyelomaActiveA Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory MyelomaI24/40N/AINTERVENTION
4510184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I5/34N/AINTERVENTION
4610208LAO-11030ETCTNGastrointestinal CancerActiveA Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic AdenocarcinomaI/II33/74377SCREENING, INTERVENTION
4710214LAO-MD017ETCTNGastrointestinal Cancer;Skin Cancer;Solid TumorTemporarily Closed to AccrualImmune Checkpoint Blockade for Kidney Transplant Recipients with Selected Unresectable or Metastatic CancersI12/16N/AINTERVENTION
4810272NCICCRMISCELLANEOUSMale Reproductive System CancerActiveA Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate CancerII185/200N/AINTERVENTION
4910296LAO-TX035ETCTNBreast CancerActivePhase Ib/II Trial of Copanlisib in Combination with Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) with PIK3CA Mutation or PTEN MutationI/II2/12N/AINTERVENTION
5010327LAO-CA043ETCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Phase I Trial of MLN0128 (Sapanisertib) and Telaglenastat (CB-839) HCL in Advanced NSCLC PatientsI13/85N/AINTERVENTION