Protocol list

Protocol List

The Protocol List provides a listing of NCI clinical trials that are supported by the CTSU and are either active, near activation or temporarily closed. The list may be sorted by Protocol Number, Lead Organization, NIH Program, Status, or Phase. Clicking to the right of each title in the header row will display an arrow, an upwards facing arrow will sort by ascending order and a downwards facing arrow will display by descending order. Each protocol number is hyperlinked and clicking on the protocol number will open a new website, the National Cancer Institute’s Clinical Trials Physicians Data Query (PDQ®). PDQ provides additional information about each clinical trial including the trial summary, eligibility criteria and a listing of sites that have the trial open. The protocol list can be exported to and Excel or CSV file or printed by selecting the icon located above the header row.

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NIH Program:

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Disease:

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*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	Disease	Status	Protocol Title	Phase	Accrual Target	Accrual Total
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1	EAY131-S2	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol S2: Phase II Study of Trametinib in Patients with Tumors with GNAQ or GNA11 Mutations		0	0
2	EAY131-Z1H	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol Z1H: Phase II Study of Copanlisib in Patients with Tumors with Deleterious PTEN Sequencing Result and PTEN Expression by IHC		0	0
3	EAY131-Z1I	ECOG-ACRIN	NCTN	N/A	Temporarily Closed to Accrual	MATCH Treatment Subprotocol Z1I: Phase II Study of AZD1775 in Patients with Tumors Containing BRCA1 and BRCA2 Mutations		0	0
4	PBTC-049	PBTC	MISCELLANEOUS	CNS Cancer (Primary tumor)	Active	A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors	I	36	0
5	PBTC-051	PBTC	MISCELLANEOUS	CNS Cancer (Primary tumor)	Active	Phase 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 Glioma	I	45	6
6	URCC-16092	URCC	NCORP	Gastrointestinal Cancer	Active	Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy	II	86	0
7	WF-20817CD	WAKE	NCORP	Lung, Mediastinal, and Pleural Cancer	Active	Implementation of Smoking Cessation Services within NCI NCORP Community Sites with Organized Lung Cancer Screening Programs	Other	1114	0
8	EAY131-K1	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol K1: Phase II Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Amplifications		0	0
9	EAY131-K2	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol K2: Phase II Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Mutations and Fusions		0	0
10	EAY131-C2	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol C2: Crizotinib in Patients with Tumors with MET Exon 14 Deletion		0	0
11	A061402	ALLIANCE	NCTN	Myeloma	Active	Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy	III	110	11
12	S1605	SWOG	NCTN	Urothelial/ Bladder Cancer	Active	Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer	II	148	99
13	9903	LAO-MA036	ETCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Phase 1B Study of AZD9291 in Combination with Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor	I	50	21
14	EA5142	ECOG-ACRIN	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers	III	714	567
15	NRG-GI002	NRG	NCTN	Gastrointestinal Cancer	Active	A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer	II	348	214
16	S1418	SWOG	NCTN	Breast Cancer	Active	A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy	III	1000	303
17	A011502	ALLIANCE	NCTN	Breast Cancer	Active	A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial	III	2936	860
18	10020	LAO-CT018	ETCTN	Breast Cancer	Active	A 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 Cancer	II	90	14
19	9948	LAO-MN026	ETCTN	Female Reproductive System Cancer	Active	Phase 1 Dose Escalation and Randomized Phase 2 Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer	I/II	24	6
20	9775	LAO-MN026	ETCTN	Leukemia	Temporarily Closed to Accrual	A Phase 2 Study of MLN0128 (TAK-228) in Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)	II	35	16
21	S1512	SWOG	NCTN	Skin Cancer	Active	A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)	II	77	17
22	9910	LAO-11030	ETCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Phase 1 Trial of MLN0128 (TAK-228) in Combination with Osimertinib (AZD9291) in Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR Tyrosine Kinase Inhibitor	I	36	12
23	EA8143	ECOG-ACRIN	NCTN	Kidney Cancer	Active	A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)	III	766	120
24	9979	LAO-MN026	ETCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	Phase 1 and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2-Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Brain Metastases	I	47	5
25	9767	LAO-CT018	ETCTN	Urothelial/ Bladder Cancer	Active	An Open Label, Multicenter, Single Arm Phase II Study to Evaluate the Activity and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK-228), in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Whose Tumors Harbor a TSC1 and/or a TSC2 Mutation	II	209	11
26	9984	LAO-CT018	ETCTN	Male Reproductive System Cancer	Active	A Randomized Phase 2 Study of Cediranib in Combination with Olaparib Versus Olaparib Alone in Men with Metastatic Castration Resistant Prostate Cancer	II	90	86
27	A221502	ALLIANCE	NCORP	Lung, Mediastinal, and Pleural Cancer	Active	Pulmonary Rehabilitation Before Lung Cancer Resection	III	194	9
28	10005	LAO-NCI	ETCTN	Soft Tissue Cancer/Sarcoma	Active	A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma	II	26	23
29	10031	LAO-MA036	ETCTN	Breast Cancer;Female Reproductive System Cancer;Miscellaneous and Metastatic Cancer	Active	A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors with Expansion in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer	I	40	16
30	S1616	SWOG	NCTN	Skin Cancer	Active	A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent	II	94	26
31	EAF151	ECOG-ACRIN	NCTN	CNS Cancer (Primary tumor)	Active	Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma	II	165	24
32	10013	LAO-NC010	ETCTN	Breast Cancer	Temporarily Closed to Accrual	Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, with or Without Atezolizumab in Triple Negative Breast Cancer (TNBC)	II	60	60
33	EA8134	ECOG-ACRIN	NCTN	Male Reproductive System Cancer	Active	InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)	III	200	8
34	NRG-GI003	NRG	NCTN	Gastrointestinal Cancer	Active	A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma	III	167	21
35	10026	LAO-MA036	ETCTN	Leukemia	Active	A Phase 1 Study of Ipilimumab in Combination with Decitabine in Relapsed or Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia	I	48	18
36	NRG-BR005	NRG	NCTN	Breast Cancer	Active	A 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 Surgery	II	175	71
37	EA1151	ECOG-ACRIN	NCORP	Breast Cancer	Active	Tomosynthesis Mammographic Imaging Screening Trial (TMIST)	III	164946	5686
38	9974	LAO-MA036	ETCTN	Lung, Mediastinal, and Pleural Cancer	Temporarily Closed to Accrual	A Phase II Study of Olaparib Plus Cediranib in Combination with Standard Therapy for Small Cell Lung Cancer	II	132	9
39	10009	LAO-CT018	ETCTN	Leukemia	Active	A Phase 1b Study of the Anti-PD1 Antibody Pembrolizumab in Combination with the Histone Deacetylase Inhibitor, Entinostat for Treatment of Patients with Myelodysplastic Syndromes After DNA Methyltransferase Inhibitor Therapy Failure	I	27	7
40	10042	LAO-CT018	ETCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Phase II Trial of AZD9291 (Osimertinib) with or without Bevacizumab in Patients with EGFR Mutation Positive NSCLC and Brain Metastases	II	98	2
41	10030	LAO-MD017	ETCTN	Leukemia	Active	A Phase 1 Study of Blinatumomab in Combination with Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients with Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia	I	30	8
42	10015	EDDO-MI014	MISCELLANEOUS	Soft Tissue Cancer/Sarcoma	Temporarily Closed to Accrual	A Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid Hemangioendothelioma	II	29	29
43	10021	LAO-MA036	ETCTN	Gastrointestinal Cancer;Lung, Mediastinal, and Pleural Cancer	Active	A Phase 2 Study of MEDI4736 (Durvalumab) and Tremelimumab Alone or in Combination with High or Low-Dose Radiation in Metastatic Colorectal and NSCLC	II	180	88
44	NRG-GY009	NRG	NCTN	Female Reproductive System Cancer	Active	A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer	II/III	488	141
45	EAY131-J	ECOG-ACRIN	NCTN	N/A	Active	MATCH Treatment Subprotocol J; Trastuzumab and Pertuzumab (HP) in Patients with Non-Breast, Non-Gastric/GEJ Cancers, and Non-Colorectal Cancers with HER2 Amplification		0	0
46	A041501	ALLIANCE	NCTN	Leukemia	Active	A 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 ALL	III	324	17
47	NRG-LU002	NRG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial	II/III	400	21
48	ADVL1622	COG	NCTN	Bone Cancer;Endocrine Cancer;Gastrointestinal Cancer;Kidney Cancer;Miscellaneous and Metastatic Cancer;Soft Tissue Cancer/Sarcoma	Active	Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors	II	146	86
49	AALL15P1	COG	NCTN	Leukemia	Temporarily Closed to Accrual	A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A(MLL) Gene Rearrangement	II	116	58
50	A191402CD	ALLIANCE	NCORP	Male Reproductive System Cancer	Active	Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men	III	172	131