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
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 CancerII68/90N/AINTERVENTION
310066LAO-CT018ETCTNGastrointestinal CancerActiveA Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)I/II40/49N/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/II29/96N/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/II1/48N/AINTERVENTION
610211LAO-CT018ETCTNGastrointestinal CancerActiveA Phase 2 Single-Arm Study of M6620 in Combination with Irinotecan in Patients with Progressive TP53 Mutant Gastric and Gastro-Esophageal Junction CancerII0/280SCREENING,INTERVENTION
710216LAO-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/II1/18N/AINTERVENTION
810246LAO-11030ETCTNLeukemiaActiveA Phase 1 Study of MLN4924 (Pevonedistat) and Belinostat in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic SyndromeI6/45N/AINTERVENTION
910302LAO-NJ066ETCTNBreast CancerActivePhase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast CancerII0/70N/AINTERVENTION
109979LAO-MN026ETCTNMiscellaneous 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
11A031102ALLIANCENCTNCNS 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 TumorsIII286/420N/AINTERVENTION
12A031704ALLIANCENCTNKidney 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]III169/1046N/AINTERVENTION
13A211601ALLIANCENCORPBreast CancerActiveEvaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502IIIN/AN/AOTHER
14A211701ALLIANCENCORPN/AActiveA Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) CohortIIIN/AN/AOTHER
15EA6141ECOG-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
16EA6174ECOG-ACRINNCTNSkin CancerActiveSTAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III TrialIII69/500N/AINTERVENTION
17EA8143ECOG-ACRINNCTNKidney CancerActiveA Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)III506/766561SCREENING,INTERVENTION
18EA8171ECOG-ACRINNCTNMale Reproductive System CancerActiveMultiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate CancerII189/852N/AINTERVENTION
19EA9131ECOG-ACRINNCORPLeukemiaActiveA Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)II161/200N/AINTERVENTION
20EAI142ECOG-ACRINNCTNBreast CancerActive[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast CancerII72/99N/AINTERVENTION
21EAQ171CDECOG-ACRINNCORPMiscellaneous and Metastatic CancerActiveImplementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"II60/30885SCREENING,INTERVENTION
22NCICOVIDNCINCIHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveNCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History StudyOtherN/A38SCREENING,OTHER
23NRG-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
24NRG-GY018NRGNCTNFemale Reproductive System CancerTemporarily Closed to AccrualA Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial CancerIII95/810N/AINTERVENTION
25NSABP-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 ChemotherapyIII1537/1636N/AINTERVENTION
26RTOG-1112NRGNCTNGastrointestinal CancerActiveRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular CarcinomaIII191/292N/AINTERVENTION
27S1512SWOGNCTNSkin CancerActiveA Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)II39/56N/AINTERVENTION
28S1826SWOGNCTNLymphomaActiveA 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 LymphomaIII149/987N/AINTERVENTION
29S1933SWOGNCTNLung, 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
30TRC-10446NCINCIHematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic CancerActiveTocilizumab in Hospitalized Cancer Patients with Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19)II1/217N/AINTERVENTION
3110061LAO-PA015ETCTNMiscellaneous and Metastatic CancerActiveA Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid TumorsI14/36N/AINTERVENTION
3210070LAO-MD017ETCTNLung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic CancerTemporarily Closed to AccrualPhase 1/2 Study of Navitoclax Plus Vistusertib in Patients with Relapsed Small Cell Lung Cancer (SCLC) and Other Solid TumorsI/II14/24N/AINTERVENTION
3310096LAO-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/II10/18N/AINTERVENTION
3410145LAO-NCIETCTNLymphoma;Miscellaneous and Metastatic CancerActivePhase Ib Combination Study of Copanlisib and Nivolumab in Advanced Solid Tumors and LymphomasI25/41N/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 CancerII8/24N/AINTERVENTION
3610170LAO-CT018ETCTNKidney Cancer;Miscellaneous and Metastatic CancerActiveA Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor MalignanciesII15/60N/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 TumorsI8/102N/AINTERVENTION
3910220LAO-TX035ETCTNCNS Cancer (Primary tumor);Lung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic Cancer;Soft Tissue Cancer/SarcomaActiveA Phase II Basket Trial of Glutaminase Inhibitor (BeGIN) CB-839 HCl in Patients with NF1 Aberrations, NF1 Mutant Malignant Peripheral Nerve Sheath Tumors (MPNST), KEAP1/NRF2 and LKB1 Aberrant TumorsII10/108N/AINTERVENTION
409924LAO-CA043ETCTNLymphomaActiveA Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)I22/44N/AINTERVENTION
419948LAO-MN026ETCTNFemale Reproductive System CancerActivePhase 1 Dose Escalation and Expansion Cohort of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube CancerI20/24N/AINTERVENTION
42A021502ALLIANCENCTNGastrointestinal CancerActiveRandomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairIII316/700N/AINTERVENTION
43A021703ALLIANCENCTNGastrointestinal CancerActiveRandomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)III66/402N/AINTERVENTION
44A021806ALLIANCENCTNGastrointestinal CancerActiveA Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerIII0/3520SCREENING,INTERVENTION
45A031702ALLIANCENCTNGerm Cell Cancer;Kidney Cancer;Male Reproductive System Cancer;Miscellaneous and Metastatic Cancer;Urothelial/ Bladder CancerActiveA Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)II80/171N/AINTERVENTION
46A031803ALLIANCENCTNUrothelial/ Bladder CancerTemporarily Closed to AccrualPhase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder CancerII8/163N/AINTERVENTION
47A041501ALLIANCENCTNLeukemiaActiveA 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 ALLIII117/324N/AINTERVENTION
48A081801ALLIANCENCTNLung, Mediastinal, and Pleural CancerActiveIntegration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IOIII1/1263N/AINTERVENTION
49A151804ALLIANCENCTNMiscellaneous and Metastatic CancerActiveEstablishment of a National Biorepository to Advance Studies of Immune-Related Adverse EventsOther5/240N/AINTERVENTION
50A221505ALLIANCENCORPBreast CancerActiveRT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast ReconstructionIII559/880N/AINTERVENTION