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 MalignanciesPilot19/40N/AINTERVENTION
210020LAO-CT018ETCTNBreast CancerActiveA Phase II Open-Label, Randomized Study of PARP Inhibition (Olaparib) Either Alone or in Combination with Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) in Homologous DNA Repair (HDR) Deficient, Locally Advanced or Metastatic Non-HER2-Positive Breast CancerII50/90N/AINTERVENTION
310066LAO-CT018ETCTNGastrointestinal CancerActiveA Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)I/II32/49N/AINTERVENTION
410150LAO-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/II24/96N/AINTERVENTION
510200LAO-MD017ETCTNLeukemiaActiveA Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination with Azacitidine in Patients with 11q23-Rearranged Acute Myeloid LeukemiaI/II0/48N/AINTERVENTION
610216LAO-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/II0/18N/AINTERVENTION
710276LAO-NJ066ETCTNGastrointestinal Cancer;Miscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary MalignanciesI/II0/30N/AINTERVENTION
810302LAO-NJ066ETCTNBreast CancerActivePhase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast CancerII0/70N/AINTERVENTION
99974LAO-MA036ETCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Phase II Study of Olaparib Plus Cediranib in Combination with Standard Therapy for Small Cell Lung CancerII9/132N/AINTERVENTION
10A031102ALLIANCENCTNCNS Cancer (Primary tumor);Germ Cell CancerActiveA Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell TumorsIII255/420N/AINTERVENTION
11A031704ALLIANCENCTNKidney CancerActivePD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]III71/1046N/AINTERVENTION
12A211601ALLIANCENCORPBreast CancerActiveEvaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502IIIN/AN/AOTHER
13A211701ALLIANCENCORPN/AActiveA Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) CohortIIIN/AN/AOTHER
14ACCL16N1CDCOGNCORPLeukemiaActiveDocumentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)OtherN/AN/AOTHER
15EA2165ECOG-ACRINNCTNGastrointestinal CancerActiveA Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal CancerII131/200N/AINTERVENTION
16EA6141ECOG-ACRINNCTNSkin CancerTemporarily Closed to AccrualRandomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV MelanomaII/III250/400N/AINTERVENTION
17EA6174ECOG-ACRINNCTNSkin CancerActiveSTAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III TrialIII37/500N/AINTERVENTION
18EA8143ECOG-ACRINNCTNKidney CancerActiveA Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)III379/766429SCREENING,INTERVENTION
19EA8171ECOG-ACRINNCTNMale Reproductive System CancerActiveMultiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate CancerII121/852N/AINTERVENTION
20EA9131ECOG-ACRINNCORPLeukemiaActiveA Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)II139/200N/AINTERVENTION
21EAI142ECOG-ACRINNCTNBreast CancerActive[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast CancerII68/99N/AINTERVENTION
22NRG-BR002NRGNCTNMiscellaneous and Metastatic CancerTemporarily Closed to AccrualA Phase IIR/III Trial of Standard of Care Therapy with or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast CancerII/III129/360N/AINTERVENTION
23NRG-GU006NRGNCTNMale Reproductive System CancerActiveA Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate CancerII258/324N/AINTERVENTION
24NSABP-B-51NRGNCTNBreast CancerActiveA Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant ChemotherapyIII1436/1636N/AINTERVENTION
25RTOG-1112NRGNCTNGastrointestinal CancerActiveRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular CarcinomaIII186/368N/AINTERVENTION
26S1512SWOGNCTNSkin CancerActiveA Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)II35/56N/AINTERVENTION
27S1826SWOGNCTNLymphomaActiveA Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin LymphomaIII37/987N/AINTERVENTION
2810057LAO-NJ066ETCTNFemale Reproductive System Cancer;Lymphoma;Skin CancerTemporarily Closed to AccrualA 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 TumorsII38/68N/AINTERVENTION
2910061LAO-PA015ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI14/36N/AINTERVENTION
3010070LAO-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
3110075LAO-CA043ETCTNLeukemiaActiveA Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid LeukemiaI15/48N/AINTERVENTION
3210096LAO-CT018ETCTNMale Reproductive System CancerActiveA Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE)I/II6/18N/AINTERVENTION
3310145LAO-NCIETCTNLymphoma;Miscellaneous and Metastatic CancerActivePhase Ib Combination Study of Copanlisib and Nivolumab in Advanced Solid Tumors and LymphomasI24/41N/AINTERVENTION
3410146LAO-NC010ETCTNBreast CancerTemporarily Closed to AccrualRandomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Neoantigen Vaccine Vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) in Patients with Metastatic Triple Negative Breast CancerII0/70N/AINTERVENTION
3510166LAO-MD017ETCTNLung, Mediastinal, and Pleural CancerActiveA Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung CancerII6/24N/AINTERVENTION
3610170LAO-CT018ETCTNKidney Cancer;Miscellaneous and Metastatic CancerActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII9/60N/AINTERVENTION
3710193LAO-MN026ETCTNLymphomaActivePhase 2 Study of Copanlisib in Combination with Nivolumab in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal Large B-Cell LymphomaII1/106N/AINTERVENTION
3810217LAO-TX035ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients with Advanced Solid TumorsI3/102N/AINTERVENTION
3910266LAO-NJ066ETCTNLung, Mediastinal, and Pleural CancerTemporarily Closed to AccrualA Phase 2 Study of MLN4924 (Pevonedistat) in Combination with Carboplatin and Paclitaxel in Advanced NSCLC Previously Treated with ImmunotherapyII0/25N/AINTERVENTION
40A021502ALLIANCENCTNGastrointestinal CancerActiveRandomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairIII261/700N/AINTERVENTION
41A021703ALLIANCENCTNGastrointestinal CancerActiveRandomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)III6/402N/AINTERVENTION
42A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII87/324N/AINTERVENTION
43A051701ALLIANCENCTNLymphomaActiveRandomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing LymphomasII/III12/367N/AINTERVENTION
44A071401ALLIANCENCTNCNS Cancer (Primary tumor)Temporarily Closed to AccrualPhase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 MutationsII40/124322SCREENING,INTERVENTION
45A171601ALLIANCENCORPBreast CancerActiveA Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast CancerII83/88N/AINTERVENTION
46A221505ALLIANCENCORPBreast CancerActiveRT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast ReconstructionIII421/880N/AINTERVENTION
47AREN1721COGNCTNKidney CancerActiveA 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 GroupsII6/87N/AINTERVENTION
48CITN-12CITNMISCELLANEOUSAIDS-related Malignancy and Condition;Gastrointestinal Cancer;Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Lung, Mediastinal, and Pleural Cancer;Lymphoma;Miscellaneous and Metastatic Cancer;Skin CancerActivePhase I Study of MK-3475 (Pembrolizumab) in Patients with Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant NeoplasmI39/63N/AINTERVENTION
49E4512ECOG-ACRINNCTNLung, Mediastinal, and Pleural CancerActiveA Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion ProteinIII100/168N/AINTERVENTION
50EA1131ECOG-ACRINNCTNBreast CancerActiveA Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant ChemotherapyIII319/562448SCREENING,INTERVENTION