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 CancerII64/70N/AINTERVENTION
210292LAO-NCIETCTNSolid TumorActiveDURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody Durvalumab in Combination with Chemotherapy in Patients with Advanced Solid TumorsII80/115N/AINTERVENTION
310299LAO-NCIETCTNLymphoma;Solid TumorActiveA Phase I Study to Investigate the Safety of the Ubiquitin Activating Enzyme Inhibitor TAK-243 in Adult Solid Tumor and Lymphoma PatientsI3/95N/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/II56/105N/AINTERVENTION
510504LAO-NCIETCTNSoft Tissue Cancer/SarcomaActiveA Phase 2 Study of Atezolizumab with Selinexor in Alveolar Soft Part Sarcoma (AXIOM)II18/27N/AINTERVENTION
610528LAO-MA036ETCTNSolid TumorActiveA Phase 1 Study of the Polymerase Theta (POL¿) Inhibitor Novobiocin in BRCA- Mutant and Other DNA Damage Repair-Deficient Solid TumorsI16/43N/AINTERVENTION
710579LAO-PA015ETCTNGastrointestinal Cancer;Solid TumorActivePhase I Trial of ZEN003694 (ZEN-3694) in Combination with Capecitabine in Patients with Solid TumorsI21/30N/AINTERVENTION
810629LAO-MD017ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined with Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients with Extensive-Stage Small Cell Lung CancerI/II10/9N/AINTERVENTION
910630LAO-PA015ETCTNLeukemiaActivePhase 1 Trial of Iadademstat in Combination with Venetoclax and Azacitidine in Patients with Treatment Naive AMLI7/45N/AINTERVENTION
1010695LAO-MA036ETCTNLeukemiaTemporarily Closed to Accrual &TreatmentPhase 1 Study of Lintuzumab-Ac225 Monotherapy for Patients with Hypomethylating Agent-Refractory Myelodysplastic SyndromeI0/18N/AINTERVENTION
11A032102ALLIANCENCTNMale Reproductive System CancerActivePREcision DIagnostics in Prostate Cancer Treatment (PREDICT)II23/474N/AINTERVENTION
12A032304ALLIANCENCTNMale Reproductive System CancerActiveRadioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC with Lutetium 177Lu PSMA RLT (RECIPROCAL)III0/838N/AINTERVENTION
13A041703ALLIANCENCTNLeukemiaActiveA 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 DiseaseII64/64N/AINTERVENTION
14A071401ALLIANCENCTNCNS Cancer (Primary tumor)ActivePhase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway MutationsII96/124524SCREENING, INTERVENTION
15A072201ALLIANCENCTNCNS Cancer (Primary tumor)ActiveRandomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients with Recurrent GlioblastomaII72/184N/AINTERVENTION
16A082101ALLIANCENCTNLung, Mediastinal, and Pleural CancerActiveMultimodality Therapy with Immunotherapy in Stage I-IIIA Pleural MesotheliomaII8/26N/AINTERVENTION
17A091903ALLIANCENCTNSkin CancerActiveA Randomized Phase II Trial of Adjuvant Nivolumab with or Without Cabozantinib in Patients with Resected Mucosal MelanomaII96/99N/AINTERVENTION
18A092105ALLIANCENCTNHead 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 ImmunotherapyII24/50N/AINTERVENTION
19A222301ALLIANCENCORPHead and Neck CancerActiveHigh-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical TrialIII11/228N/AINTERVENTION
20A232402CDALLIANCENCORPGastrointestinal CancerActivePAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned DelaysIII2/420N/AINTERVENTION
21ARAR2221COGNCTNHead and Neck CancerActiveA Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)II34/50N/AINTERVENTION
22CCTG-NE1CCTGNCTNEndocrine CancerActiveNET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic/Unresectable Gastroenteropancreatic Neuroendocrine TumoursII33/100N/AINTERVENTION
23CCTG-PR26CCTGNCTNMale Reproductive System CancerActiveA Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)III10/830N/AINTERVENTION
24EA2174ECOG-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
25EA2185ECOG-ACRINNCORPGastrointestinal CancerActiveComparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated BiomarkersII531/750N/AINTERVENTION
26EA2192ECOG-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 MutationII104/152N/AINTERVENTION
27EA4232ECOG-ACRINNCTNLymphomaActiveA Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)III9/294N/AINTERVENTION
28EA5231ECOG-ACRINNCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Randomized Phase III Trial of Checkpoint Blockade in Lung CancEr Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)III10/63015SCREENING, INTERVENTION
29EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III145/200N/AINTERVENTION
30EA8192ECOG-ACRINNCTNUrothelial/ Bladder CancerActiveA Phase II/III Trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to NephroureterectomyII/III102/249N/AINTERVENTION
31EA9213ECOG-ACRINNCTNLeukemiaActiveA Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/T-LBL)II14/20N/AINTERVENTION
32EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III248/288N/AINTERVENTION
33EAQ221CDECOG-ACRINNCORPBreast CancerActiveImproving Medication Adherence in Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)Other312/390N/AINTERVENTION
34EAY191ECOG-ACRINNCTNLymphoma;Solid TumorActiveMolecular Analysis for Combination Therapy Choice (ComboMATCH)OtherN/A578SCREENING
35EAY191-N5NRGNCTNBone Cancer;CNS Cancer (Primary tumor);Endocrine Cancer;Female Reproductive System Cancer;Gastrointestinal Cancer;Germ Cell Cancer;Head and Neck Cancer;Kidney Cancer;Lung, Mediastinal, and Pleural Cancer;Male Reproductive System Cancer;Miscellaneous and Metastatic Cancer;Skin Cancer;Soft Tissue Cancer/Sarcoma;Solid Tumor;Urothelial/ Bladder CancerActiveA Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination with Palbociclib, a CDK4/6 Inhibitor, in Patients with HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment TrialII26/70N/AINTERVENTION
36NRG-CC011NRGNCORPBreast CancerActiveCognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled TrialIII347/386N/AINTERVENTION
37NRG-CC013NRGNCORPHead and Neck CancerActiveA Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent ChemoradiationII36/98N/AINTERVENTION
38NRG-CC015NRGNCORPBreast CancerActiveHarnessing E-Mindfulness Approaches for Living After Breast Cancer --- HEAL-ABCIII68/402N/AINTERVENTION
39NRG-GU012NRGNCTNKidney CancerActiveRandomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)II119/240N/AINTERVENTION
40NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI316/350N/AINTERVENTION
41NRG-GY032NRGNCTNFemale Reproductive System CancerActiveA Phase II Study of Tailored Adjuvant Therapy in Pole-Mutated and p53-Wildtype/NSMP Early-Stage Endometrial Cancer (RAINBO BLUE & TAPER)II42/395N/AINTERVENTION
42NRG-GY037NRGNCTNFemale Reproductive System CancerActiveA Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical CancerIII13/336N/AINTERVENTION
43S1703SWOGNCORPBreast CancerActiveRandomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive HER-2 Negative Breast CancerOther449/498665SCREENING, INTERVENTION
44S1800ESWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase II/III Study of Docetaxel and Ramucirumab with or Without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)II/III64/378N/AINTERVENTION
45S2012SWOGNCTNEndocrine 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/III138/189N/AINTERVENTION
46S2013SWOGNCORPN/AActiveImmune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational StudyOtherN/AN/AOTHER
47S2200SWOGNCTNKidney CancerTemporarily Closed to AccrualA Phase II Randomized Trial of Cabozantinib (NSC #761968) with or Without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma (PAPMET2)II36/200N/AINTERVENTION
48S2207SWOGNCTNLymphomaActiveRandomized 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 LymphomaII38/241N/AINTERVENTION
49S2209SWOGNCTNMyelomaActiveA Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent MaintenanceIII114/510N/AINTERVENTION
50S2409SWOGNCTNLung, Mediastinal, and Pleural CancerActivePRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)II1/29216SCREENING, INTERVENTION