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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110030LAO-MD017ETCTNLeukemiaTemporarily Closed to AccrualA Phase 1 Study of Blinatumomab in Combination with Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients with Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic LeukemiaI27/30N/AINTERVENTION
210061LAO-PA015ETCTNSolid TumorActiveA Phase 1 Study of Pembrolizumab (MK-3475) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI30/36N/AINTERVENTION
310146LAO-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 CancerII11/70N/AINTERVENTION
410287LAO-CT018ETCTNBreast CancerActiveA Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination with Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)I/II21/24N/AINTERVENTION
510292LAO-NCIETCTNSolid TumorActiveDURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody Durvalumab in Combination with Chemotherapy in Patients with Advanced Solid TumorsII64/115N/AINTERVENTION
610301LAO-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/II12/24N/AINTERVENTION
710330LAO-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
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)II4/77N/AINTERVENTION
1010505LAO-CA043ETCTNCNS Cancer (Primary tumor)ActiveA Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent GlioblastomaI/II0/24N/AINTERVENTION
1110507LAO-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
1210517LAO-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
139892LAO-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 CancerI19/76N/AINTERVENTION
14A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII149/352N/AINTERVENTION
15A021901ALLIANCENCTNEndocrine CancerActiveRandomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine TumorsII0/108N/AINTERVENTION
16A051902ALLIANCENCTNLymphomaActiveA 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 LymphomasII14/182N/AINTERVENTION
17A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII85/124424SCREENING, INTERVENTION
18A091802ALLIANCENCTNSkin CancerActivePhase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)II56/59N/AINTERVENTION
19A091903ALLIANCENCTNSkin CancerActiveA Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal MelanomaII5/99N/AINTERVENTION
20A171901ALLIANCENCORPLung, 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)II88/100N/AINTERVENTION
21A211801ALLIANCENCORPN/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
22A212102ALLIANCENCORPMiscellaneous and Metastatic CancerActiveBlinded Reference Set For Multicancer Early Detection Blood TestsOtherN/AN/AOTHER
23AMC-112AMCMISCELLANEOUSAIDS-related Malignancy and ConditionTemporarily Closed to AccrualAxicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin LymphomaI0/200SCREENING, INTERVENTION
24DCP-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
25EA1181ECOG-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)II1778/2156N/AINTERVENTION
26EA2174ECOG-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
27EA2187ECOG-ACRINNCTNGastrointestinal CancerTemporarily Closed to AccrualA Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic CholangiocarcinomaII40/52N/AINTERVENTION
28EA2192ECOG-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 MutationII29/152N/AINTERVENTION
29EA5162ECOG-ACRINNCTNLung, Mediastinal, and Pleural CancerActivePhase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFRII21/46N/AINTERVENTION
30EA6141ECOG-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/III389/601N/AINTERVENTION
31EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III67/200N/AINTERVENTION
32EA8192ECOG-ACRINNCTNUrothelial/ Bladder CancerActiveA Phase II/III Trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to NephroureterectomyII/III12/249N/AINTERVENTION
33EA8212ECOG-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
34EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III128/288N/AINTERVENTION
35NRG-GU012NRGNCTNKidney CancerActiveRandomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)II0/240N/AINTERVENTION
36NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI227/350N/AINTERVENTION
37PBTC-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 GliomaI32/45N/AINTERVENTION
38PEPN2111PEP-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
39S0820SWOGNCORPGastrointestinal 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)III346/389N/AINTERVENTION
40S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII287/817306SCREENING, INTERVENTION
41S1905SWOGNCTNLeukemia;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/II13/64N/AINTERVENTION
42S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII171/480N/AINTERVENTION
43S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII27/47N/AINTERVENTION
44S1937SWOGNCTNUrothelial/ 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 TherapyIII20/465N/AINTERVENTION
45S2005SWOGNCTNLymphomaTemporarily 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
46S2012SWOGNCTNEndocrine 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/III6/189N/AINTERVENTION
47S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
4810184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I7/34N/AINTERVENTION
4910208LAO-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/II45/74493SCREENING, INTERVENTION
5010324LAO-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)I23/49N/AINTERVENTION