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 TumorsI29/36N/AINTERVENTION
210301LAO-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/II11/24N/AINTERVENTION
310330LAO-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
410406LAO-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
510504LAO-NCIETCTNSoft Tissue Cancer/SarcomaActiveA Randomized Phase 2 Study of Atezolizumab with or Without Selinexor in Alveolar Soft Part Sarcoma (AXIOM)II3/77N/AINTERVENTION
610507LAO-MA036ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination with Etoposide/Platinum in Patients with NUT CarcinomaI/II4/18N/AINTERVENTION
710517LAO-11030ETCTNUrothelial/ Bladder CancerActiveAn Open Label, Randomized Phase II Study Neoadjuvant Erdafitinib with or Without Atezolizumab in Cisplatin-Ineligible Patients with Muscle Invasive Bladder Cancer (NERA)II0/44N/AINTERVENTION
89892LAO-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 CancerI16/76N/AINTERVENTION
99938LAO-PA015ETCTNSolid TumorActivePhase I Clinical Trial of M6620 (VX-970, Berzosertib) in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid TumorsI66/66N/AINTERVENTION
10A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII141/352N/AINTERVENTION
11A021901ALLIANCENCTNEndocrine CancerActiveRandomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine TumorsII0/108N/AINTERVENTION
12A041703ALLIANCENCTNLeukemiaActiveA 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 DiseaseII53/64N/AINTERVENTION
13A051902ALLIANCENCTNLymphomaActiveA 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 LymphomasII13/182N/AINTERVENTION
14A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII85/124421SCREENING, INTERVENTION
15A091903ALLIANCENCTNSkin CancerActiveA Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal MelanomaII2/99N/AINTERVENTION
16A171901ALLIANCENCORPLung, 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)II86/100N/AINTERVENTION
17A211801ALLIANCENCORPN/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
18A212102ALLIANCENCORPMiscellaneous and Metastatic CancerActiveBlinded Reference Set For Multicancer Early Detection Blood TestsOtherN/AN/AOTHER
19AMC-112AMCMISCELLANEOUSAIDS-related Malignancy and ConditionTemporarily Closed to AccrualAxicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin LymphomaI0/200SCREENING, INTERVENTION
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)II1704/2156N/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 MutationII28/152N/AINTERVENTION
23EA6141ECOG-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/III383/601N/AINTERVENTION
24EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III65/200N/AINTERVENTION
25EA8212ECOG-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)III0/870N/AINTERVENTION
26EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III123/288N/AINTERVENTION
27NRG-GU012NRGNCTNKidney CancerActiveRandomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)II0/240N/AINTERVENTION
28NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI223/350N/AINTERVENTION
29PBTC-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 GliomaI31/45N/AINTERVENTION
30PEPN2111PEP-CTNMISCELLANEOUSBone Cancer;CNS Cancer (Primary tumor);Lymphoma;Solid TumorTemporarily Closed to AccrualA Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients with Relapsed or Refractory Solid Tumors Including CNS Tumors and LymphomaI/II9/38N/AINTERVENTION
31S0820SWOGNCORPGastrointestinal 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)III344/389N/AINTERVENTION
32S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII286/817305SCREENING, INTERVENTION
33S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII154/480N/AINTERVENTION
34S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII26/47N/AINTERVENTION
35S1937SWOGNCTNUrothelial/ 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 TherapyIII15/465N/AINTERVENTION
36S2005SWOGNCTNLymphomaTemporarily 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
37S2012SWOGNCTNEndocrine 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/III3/189N/AINTERVENTION
38S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
3910076LAO-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 MyelomaI29/40N/AINTERVENTION
4010184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I6/34N/AINTERVENTION
4110208LAO-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/II42/74493SCREENING, INTERVENTION
4210327LAO-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
4310335LAO-CT018ETCTNLeukemia;LymphomaActiveA Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)I6/30N/AINTERVENTION
4410387LAO-PA015ETCTNAIDS-related Malignancy and Condition;Solid TumorActivePilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients with HIV InfectionI3/18N/AINTERVENTION
4510389LAO-OH007ETCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase 1 Trial Combining WEE1 Inhibitor Adavosertib (AZD1775) with Radiation Therapy for Metastatic or Inoperable and Ineligible for Definitive Chemoradiation Esophageal and Gastroesophageal Junction CancerI4/33N/AINTERVENTION
4610496LAO-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 NeckII2/52N/AINTERVENTION
4710508LAO-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)I1/27N/AINTERVENTION
48A011801ALLIANCENCTNBreast CancerActiveThe COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and TucatinibIII282/1031N/AINTERVENTION
49A021703ALLIANCENCTNGastrointestinal CancerActiveRandomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)III446/445N/AINTERVENTION
50A021804ALLIANCENCTNEndocrine CancerActiveA Prospective, Multi-Institutional Phase II Trial Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and ParagangliomaII16/76N/AINTERVENTION