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, near activation, or temporarily closed. 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. The protocol list can be exported to an Excel or CSV file, or printed by selecting the arrow icon located above the header row.

*Some accruals have occurred outside of the CTSU systems and are collected manually, thus the total accrual number may not be accurate.
#Protocol NumberLead OrganizationNIH ProgramDiseaseStatusProtocol TitlePhaseActual/Planned Intervention AccrualScreening AccrualStep Type(s)
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110014LAO-11030ETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveA Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumor MalignanciesPilot20/40N/AINTERVENTION
210026LAO-MA036ETCTNLeukemiaActiveA Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid LeukemiaI44/48N/AINTERVENTION
310057LAO-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 TumorsII40/68N/AINTERVENTION
410075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of KRT-232 (AMG-232) in Combination with Decitabine in Acute Myeloid LeukemiaI22/48N/AINTERVENTION
510146LAO-CT018ETCTNBreast CancerTemporarily Closed to AccrualRandomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients with Metastatic Triple Negative Breast CancerII0/70N/AINTERVENTION
610170LAO-CT018ETCTNKidney Cancer;Miscellaneous and Metastatic CancerActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII15/60N/AINTERVENTION
710184LAO-NCIETCTNHead and Neck CancerActiveBirinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)I1/34N/AINTERVENTION
810216LAO-OH007ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase I/II Study of AZD9291 (Osimertinib) and CB-839 HCl in Patients with EGFR Mutant Non-Small Cell Lung CancerI/II3/18N/AINTERVENTION
910219LAO-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 MyelomaI11/36N/AINTERVENTION
1010264LAO-CT018ETCTNLeukemiaActiveThe PRIME Trial: PARP Inhibition in IDH Mutant Effectiveness Trial. A Phase II Study of Olaparib in Isocitrate Dehydrogenase (IDH) Mutant Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic SyndromeII2/942SCREENING,INTERVENTION
1110276LAO-11030ETCTNGastrointestinal Cancer;Miscellaneous and Metastatic CancerActiveA Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary MalignanciesI/II6/30N/AINTERVENTION
1210291LAO-MA036ETCTNBreast CancerActiveA Phase 1b Study of M6620 in Combination with Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast CancerI0/42N/AINTERVENTION
1310296LAO-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
1410301LAO-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/II0/24N/AINTERVENTION
1510315LAO-CT018ETCTNEndocrine CancerActiveA Phase 2 Study of XL184 (Cabozantinib) in Combination with Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine CarcinomasII0/30N/AINTERVENTION
169892LAO-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 CancerI3/64N/AINTERVENTION
179950LAO-MD017ETCTNHead and Neck CancerActiveA 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)I24/45N/AINTERVENTION
189979LAO-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 MetastasesI8/47N/AINTERVENTION
19A041703ALLIANCENCTNLeukemiaActiveA 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 DiseaseII15/64N/AINTERVENTION
20A221701ALLIANCENCORPMiscellaneous and Metastatic CancerActivePhase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment)III38/279N/AINTERVENTION
21A221702ALLIANCENCORPBreast 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 MappingIII108/516N/AINTERVENTION
22AGCT1532COGNCTNGerm Cell CancerActiveA Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell TumorsIII37/150N/AINTERVENTION
23CCTG CE.7CCTGNCTNMiscellaneous and Metastatic CancerActiveA Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) plus Memantine for 5-15 Brain MetastasesIII34/206N/AINTERVENTION
24CCTG MA.39CCTGNCTNBreast CancerActiveTailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast CancerIII332/2140665SCREENING,INTERVENTION
25DCP-001DCPNCORPHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveUse of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)OtherN/AN/AOTHER
26EA1183ECOG-ACRINNCTNBreast CancerActiveFDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer, FEATUREII1/134N/AINTERVENTION
27EA5163ECOG-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 AnalysisIII205/846N/AINTERVENTION
28EA6141ECOG-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/III251/600N/AINTERVENTION
29EA8134ECOG-ACRINNCTNMale Reproductive System CancerActiveInPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)III35/200N/AINTERVENTION
30EAY131ECOG-ACRINNCTNLymphoma;Miscellaneous and Metastatic Cancer;MyelomaActiveMolecular Analysis for Therapy Choice (MATCH)II1140/14257027SCREENING,INTERVENTION
31LUNGMAPSWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)IIN/A1602SCREENING
32NRG-BN007NRGNCTNCNS Cancer (Primary tumor)ActiveA Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated GlioblastomaII/III1/4853SCREENING,INTERVENTION
33NRG-GI006NRGNCTNGastrointestinal CancerActivePhase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal CancerIII38/300N/AINTERVENTION
34NRG-GY022NRGNCTNMiscellaneous and Metastatic CancerActiveAssessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinI56/250N/AINTERVENTION
35S0820SWOGNCORPGastrointestinal 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)III290/491N/AINTERVENTION
36S1602SWOGNCTNUrothelial/ Bladder CancerActiveA Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-Muscle Invasive Bladder CancerIII850/969N/AINTERVENTION
37S1607SWOGNCTNSkin CancerActiveA Phase II Study of Combining Talimogene Laherparepvec (T-VEC) (NSC-785349) and MK-3475 (Pembrolizumab) (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based TherapyII43/47N/AINTERVENTION
38S1613SWOGNCTNGastrointestinal CancerActiveA Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 AmplificationII34/122193SCREENING,INTERVENTION
39S1701SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic CarcinomaII9/66N/AINTERVENTION
40S1933SWOGNCTNLung, Mediastinal, and Pleural CancerActiveA Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance StatusII0/47N/AINTERVENTION
4110058LAO-TX035ETCTNGastrointestinal CancerActiveA Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the RectumI3/21N/AINTERVENTION
4210061LAO-PA015ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI14/36N/AINTERVENTION
4310070LAO-MD017ETCTNLung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic CancerActivePhase 1/2 Study of Navitoclax Plus Vistusertib in Patients with Relapsed Small Cell Lung Cancer (SCLC) and Other Solid TumorsI/II14/24N/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 MyelomaI7/40N/AINTERVENTION
4510104LAO-11030ETCTNFemale Reproductive System CancerTemporarily Closed to AccrualA Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial CancerII82/84N/AINTERVENTION
4610107LAO-MA036ETCTNLung, Mediastinal, and Pleural CancerActivePhase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural MesotheliomaI/II28/11070SCREENING,INTERVENTION
4710150LAO-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/II36/96N/AINTERVENTION
4810204LAO-TX035ETCTNHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveA Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)I9/312N/AINTERVENTION
4910231DCTDNCTNMiscellaneous and Metastatic CancerActiveNCORP Tissue Procurement Protocol: An NCI Cancer Moonshot StudyPilotN/AN/AOTHER
5010272NCICCRMISCELLANEOUSMale Reproductive System CancerActiveA Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate CancerII5/200N/AINTERVENTION