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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*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	N0577	ALLIANCE	NCTN	CNS Cancer (Primary tumor)	Active	N0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma	III	361	136
2	RTOG-0724	NRG	NCTN	Female Reproductive System Cancer	Active	Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy	III	285	182
3	GOG-0263	NRG	NCTN	Female Reproductive System Cancer	Active	Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)	III	534	289
4	9149	LAO-NCI	ETCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	Molecular Profiling-Based Assignment of Cancer Therapy for Patients with Advanced Solid Tumors	Pilot	180	202
5	A031102	ALLIANCE	NCTN	CNS Cancer (Primary tumor);Germ Cell Cancer	Active	A 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 Tumors	III	420	126
6	A051301	ALLIANCE	NCTN	Lymphoma	Temporarily Closed to Accrual	A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype	III	526	32
7	EA6134	ECOG-ACRIN	NCTN	Skin Cancer	Active	A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma	III	300	159
8	S1416	SWOG	NCTN	Breast Cancer	Active	Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer	II	333	256
9	NRG-GU002	NRG	NCTN	Male Reproductive System Cancer	Active	Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant Docetaxel	II/III	612	56
10	9676	LAO-MA036	ETCTN	Female Reproductive System Cancer;Gastrointestinal Cancer;Kidney Cancer;Miscellaneous and Metastatic Cancer;Skin Cancer;Soft Tissue Cancer/Sarcoma	Temporarily Closed to Accrual	A Phase 1 Trial of MK-3475 Plus Ziv-Aflibercept in Patients with Advanced Solid Tumors	I	78	35
11	NRG-BR002	NRG	NCTN	Miscellaneous and Metastatic Cancer	Active	A Phase IIR/III Trial of Standard of Care Therapy with or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer	II/III	360	91
12	9591	LAO-11030	ETCTN	Miscellaneous and Metastatic Cancer	Active	A Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients with Hepatic Dysfunction	I	68	43
13	EA1131	ECOG-ACRIN	NCTN	Breast Cancer	Active	A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy	III	558	192
14	9466	LAO-MA036	ETCTN	Miscellaneous and Metastatic Cancer;Skin Cancer	Active	Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I only)	I/II	50	0
15	NRG-GU005	NRG	NCTN	Male Reproductive System Cancer	Active	Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer	III	606	51
16	A221505	ALLIANCE	NCORP	Breast Cancer	Active	Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction	III	880	46
17	S1613	SWOG	NCTN	Gastrointestinal Cancer	Active	A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification	II	130	9
18	S1612	SWOG	NCTN	Leukemia	Active	A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older (LEAP: Less-Intense AML Platform Trial)	II/III	1670	63
19	NRG-GI004	NRG	NCTN	Gastrointestinal Cancer	Active	Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer	III	347	13
20	10139	LAO-MD017	ETCTN	Gastrointestinal Cancer	Active	A Randomized Phase 2 Study of Atezolizumab in Combination with Cobimetinib Versus Atezolizumab Monotherapy in Participants with Unresectable Cholangiocarcinoma	II	82	76
21	ACCL16N1CD	COG	NCORP	Leukemia	Active	Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)	Other	270	52
22	10089	LAO-MN026	ETCTN	Lymphoma	Active	A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas	II	106	0
23	A221504	ALLIANCE	NCORP	Lung, Mediastinal, and Pleural Cancer	Active	A Randomized, Double-Blind, Placebo-Controlled Pilot of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)	II	204	9
24	10076	LAO-TX035	ETCTN	Myeloma	Temporarily Closed to Accrual	A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of AMG 232 in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma	I	40	2
25	S1619	SWOG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma	I	24	4
26	S1207	SWOG	NCTN	Breast Cancer	Active	Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer. e^3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy.	III	1900	1707
27	NRG-GY006	NRG	NCTN	Female Reproductive System Cancer	Active	A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer	II	188	143
28	9673	LAO-TX035	ETCTN	Gastrointestinal Cancer	Active	A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal	II	100	39
29	9706	EDDO-IL057	MISCELLANEOUS	Leukemia	Active	Randomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (REMAIN TRIAL)	II	80	61
30	EA3132	ECOG-ACRIN	NCTN	Head and Neck Cancer	Active	Phase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing	II	345	27
31	NRG-HN004	NRG	NCTN	Head and Neck Cancer	Temporarily Closed to Accrual	Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin	II/III	474	10
32	10066	LAO-CT018	ETCTN	Gastrointestinal Cancer	Active	A Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)	I/II	49	7
33	10070	LAO-MD017	ETCTN	Lung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic Cancer	Active	Phase 1/2 Study of Navitoclax Plus Vistusertib in Patients with Relapsed Small Cell Lung Cancer (SCLC) and Other Solid Tumors	I/II	24	4
34	10132	LAO-11030	ETCTN	Female Reproductive System Cancer	Active	A Phase I Study of the Wee 1 Kinase (Wee 1) Inhibitor AZD1775 in Combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)	I	24	5
35	CITN-13	CITN	MISCELLANEOUS	Lymphoma	Active	A Phase II Trial of MK-3475 (Pembrolizumab) and Interferon Gamma 1-b Combination Immunotherapy in Patients with Previously Treated Mycosis Fungoides and Sezary Syndrome	II	30	9
36	10075	LAO-CA043	ETCTN	Leukemia	Temporarily Closed to Accrual	A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia	I	48	4
37	10100	LAO-CA043	ETCTN	Urothelial/ Bladder Cancer	Active	A Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Eribulin Mesylate in Combination with Atezolizumab Compared to Atezolizumab Alone in Subjects with Locally Advanced or Metastatic Transitional Cell Urothelial Cancer Where Platinum-Based Treatment is Not an Option	II	78	1
38	A091605	ALLIANCE	NCTN	Skin Cancer	Active	A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma	II	100	2
39	10104	LAO-11030	ETCTN	Female Reproductive System Cancer	Active	A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial Cancer	II	84	33
40	A221101	ALLIANCE	NCORP	CNS Cancer (Primary tumor)	Active	A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma	III	330	291
41	9672	LAO-MA036	ETCTN	Female Reproductive System Cancer	Temporarily Closed to Accrual	A Phase 2 Study of Nivolumab and Ipilimumab in Advanced Leiomyosarcoma of the Uterus	II	37	20
42	9844	LAO-MD017	ETCTN	Breast Cancer;Miscellaneous and Metastatic Cancer	Active	A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab with or Without Ipilimumab in Advanced Solid Tumors	I	45	35
43	9846	LAO-NCI	ETCTN	Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic Cancer	Active	Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)	Other	5000	2204
44	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	9
45	S1605	SWOG	NCTN	Urothelial/ Bladder Cancer	Active	Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer	II	148	77
46	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
47	S1702	SWOG	NCTN	Immune Disorder (excluding AIDS and malignancy)	Active	A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis	II	39	5
48	10129	LAO-CT018	ETCTN	CNS Cancer (Primary tumor);Gastrointestinal Cancer;Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	A Phase 2 Study of the PARP Inhibitor Olaparib (AZD2281) in IDH1 and IDH2 Mutant Advanced Solid Tumors	II	145	0
49	10130	LAO-11030	ETCTN	Lymphoma;Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	A Phase I Study of Single Agent Tazemetostat in Subjects with Advanced Solid Tumors and B-Cell Lymphomas with Hepatic Dysfunction	I	66	0
50	10131	LAO-MD017	ETCTN	Breast Cancer;Male Reproductive System Cancer;Miscellaneous and Metastatic Cancer	Active	A Phase I Study of AZD8186 in Combination with Docetaxel in Patients with PTEN Mutated or PIK3CB Mutated Advanced Solid Tumors, Potentially Amenable to Docetaxel	I	58	0