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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110026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI50/48N/AINTERVENTION
210057LAO-MA036ETCTNFemale Reproductive System Cancer;Lymphoma;Skin CancerActiveA Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin TumorsII47/68N/AINTERVENTION
310170LAO-CT018ETCTNKidney Cancer;Solid TumorActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII16/60N/AINTERVENTION
410184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I1/34N/AINTERVENTION
510219LAO-MA036ETCTNMyelomaActivePhase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor (CB-839 HCl) in Combination with Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple MyelomaI15/36N/AINTERVENTION
610273LAO-CA043ETCTNLeukemiaActiveA Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid LeukemiaI10/48N/AINTERVENTION
710287LAO-NC010ETCTNBreast CancerTemporarily Closed to AccrualA 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/II10/24N/AINTERVENTION
810296LAO-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/II0/12N/AINTERVENTION
910301LAO-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/II4/24N/AINTERVENTION
1010315LAO-CT018ETCTNEndocrine CancerActiveA Phase 2 Study of XL184 (Cabozantinib) in Combination with Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine CarcinomasII15/30N/AINTERVENTION
1110387EDDO-NY313ETCTNAIDS-related Malignancy and Condition;Solid TumorActivePilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients with HIV InfectionI0/18N/AINTERVENTION
1210406LAO-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 CancersI0/90N/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 CancerI6/64N/AINTERVENTION
149979LAO-MD017ETCTNMiscellaneous and Metastatic CancerActivePhase 1 and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2-Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Brain MetastasesI11/47N/AINTERVENTION
15A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII24/352N/AINTERVENTION
16A041501ALLIANCENCTNLeukemiaActiveA Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALLIII179/341N/AINTERVENTION
17A041701ALLIANCENCTNLeukemiaActiveA Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction ChemotherapyII/III208/670344SCREENING, INTERVENTION
18A041703ALLIANCENCTNLeukemiaActiveA 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 DiseaseII30/64N/AINTERVENTION
19A171901ALLIANCENCORPLung, 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)II8/100N/AINTERVENTION
20A221702ALLIANCENCORPBreast 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 MappingIII219/516N/AINTERVENTION
21AREN1721COGNCTNKidney CancerTemporarily Closed to AccrualA Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age GroupsII11/70N/AINTERVENTION
22DCP-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
23EA1181ECOG-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)II364/1250N/AINTERVENTION
24EA5163ECOG-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 AnalysisIII294/846N/AINTERVENTION
25EA6141ECOG-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/III278/600N/AINTERVENTION
26EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III43/200N/AINTERVENTION
27EAA173ECOG-ACRINNCTNMyelomaActiveDaratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)III74/288N/AINTERVENTION
28NCICOVIDNCINCIHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Solid TumorActiveNCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History StudyOtherN/A1150SCREENING, OTHER
29NRG-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
30NRG-GY012NRGNCTNFemale Reproductive System CancerTemporarily Closed to AccrualA Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial CancerII120/120N/AINTERVENTION
31NRG-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 CancerIII47/168N/AINTERVENTION
32NRG-GY022NRGNCTNSolid TumorActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI121/250N/AINTERVENTION
33PBTC-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 GliomaI24/45N/AINTERVENTION
34S0820SWOGNCORPGastrointestinal 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)III313/491N/AINTERVENTION
35S1501SWOGNCORPBreast CancerActiveProspective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase IIIIII235/817250SCREENING, INTERVENTION
36S1712SWOGNCTNLeukemiaActiveA 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 DiseaseII52/84N/AINTERVENTION
37S1914SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCIII20/480N/AINTERVENTION
38S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII2/47N/AINTERVENTION
39S1937SWOGNCTNUrothelial/ 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 TherapyIII0/465N/AINTERVENTION
4010058LAO-TX035ETCTNGastrointestinal CancerActiveA Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the RectumI3/21N/AINTERVENTION
4110076LAO-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 MyelomaI9/40N/AINTERVENTION
4210150LAO-11030ETCTNFemale Reproductive System CancerActiveA Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian CancerI/II50/96N/AINTERVENTION
4310181LAO-NC010ETCTNGastrointestinal CancerActiveA Phase 2 Study of Savolitinib in Subjects with MET Amplified Metastatic Colorectal CancerII3/1557SCREENING, INTERVENTION
4410208LAO-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/II25/64236SCREENING, INTERVENTION
4510221LAO-TX035ETCTNSolid TumorActiveA Phase I/II Biomarker Driven Combination Trial of Copanlisib and Immune Checkpoint Inhibitors in Patients with Advanced Solid TumorsI/II22/102N/AINTERVENTION
4610272NCICCRMISCELLANEOUSMale Reproductive System CancerActiveA Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate CancerII33/200N/AINTERVENTION
4710335LAO-CT018ETCTNLeukemia;LymphomaActiveA Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)I0/30N/AINTERVENTION
4810349LAO-NCIETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Lymphoma;Myeloma;Solid TumorActiveA Phase I Trial of the P97 Inhibitor CB-5339 in Patients with Advanced Solid Tumors and LymphomasI1/40N/AINTERVENTION
499950LAO-MD017ETCTNHead and Neck CancerTemporarily Closed to AccrualA Phase I Study of M6620 (VX-970) in Combination with Cisplatin and XRT in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)I28/45N/AINTERVENTION
50A011801ALLIANCENCTNBreast 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 TucatinibIII4/1031N/AINTERVENTION