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	Actual/Planned Intervention Accrual	Screening Accrual	Step Type(s)
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1	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	109/180	N/A	INTERVENTION
2	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	22/48	N/A	INTERVENTION
3	10058	LAO-TX035	ETCTN	Gastrointestinal Cancer	Active	A Phase I Study of Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) with Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the Rectum	I	0/21	N/A	INTERVENTION
4	10075	LAO-CA043	ETCTN	Leukemia	Active	A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia	I	8/48	N/A	INTERVENTION
5	10181	LAO-NC010	ETCTN	Gastrointestinal Cancer	Active	A Phase 2 Study of Savolitinib in Subjects with MET Amplified Metastatic Colorectal Cancer	II	0/15	0	SCREENING,INTERVENTION
6	10200	LAO-MD017	ETCTN	Leukemia	Active	A Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination with Azacitidine in Patients with 11q23-Rearranged Acute Myeloid Leukemia	I/II	0/48	N/A	INTERVENTION
7	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	12/209	N/A	INTERVENTION
8	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	13/36	N/A	INTERVENTION
9	9938	LAO-PA015	ETCTN	Miscellaneous and Metastatic Cancer	Active	Phase I Clinical Trial of VX-970 in Combination with the Topoisomerase I Inhibitor Irinotecan in Patients with Advanced Solid Tumors	I	22/51	N/A	INTERVENTION
10	9947	LAO-CA043	ETCTN	Urothelial/ Bladder Cancer	Active	A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or Without VX-970 in Metastatic Urothelial Carcinoma	II	68/90	N/A	INTERVENTION
11	A011106	ALLIANCE	NCTN	Breast Cancer	Active	ALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study	III	1442/1475	N/A	INTERVENTION
12	A021602	ALLIANCE	NCTN	Endocrine Cancer	Active	Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)	III	10/395	N/A	INTERVENTION
13	CCTG CE.7	CCTG	NCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	A Phase III Trial of Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases	III	10/206	N/A	INTERVENTION
14	NRG-GI002	NRG	NCTN	Gastrointestinal Cancer	Active	A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer	II	311/348	N/A	INTERVENTION
15	RTOG-1112	NRG	NCTN	Gastrointestinal Cancer	Active	Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma	III	166/368	N/A	INTERVENTION
16	S0820	SWOG	NCORP	Gastrointestinal Cancer	Active	A 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)	III	233/491	N/A	INTERVENTION
17	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	1871/1900	N/A	INTERVENTION
18	S1320	SWOG	NCTN	Skin Cancer	Active	A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma	II	243/280	N/A	INTERVENTION
19	S1415CD	SWOG	NCORP	Breast Cancer;Gastrointestinal Cancer;Lung, Mediastinal, and Pleural Cancer	Active	A Pragmatic Trial to Evaluate a Guideline Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)	Other	2812/3960	N/A	INTERVENTION
20	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	21/77	N/A	INTERVENTION
21	S1600	SWOG	NCORP	Urothelial/ Bladder Cancer	Active	A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes	III	1/200	N/A	INTERVENTION
22	S1607	SWOG	NCTN	Skin Cancer	Active	A 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 Therapy	II	13/64	N/A	INTERVENTION
23	10056	LAO-MN026	ETCTN	Soft Tissue Cancer/Sarcoma	Active	A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma	II	0/40	0	SCREENING,INTERVENTION
24	10057	LAO-NJ066	ETCTN	Female Reproductive System Cancer;Lymphoma;Skin Cancer	Active	A 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 Tumors	II	36/68	N/A	INTERVENTION
25	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	5/106	N/A	INTERVENTION
26	10144	LAO-NCI	ETCTN	Urothelial/ Bladder Cancer	Active	A Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma with DNA-Repair Defects	II	0/60	0	SCREENING,INTERVENTION
27	10146	LAO-NC010	ETCTN	Breast Cancer	Active	Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Neoantigen Vaccine Vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) in Patients with Metastatic Triple Negative Breast Cancer	II	0/70	N/A	INTERVENTION
28	10212	LAO-OH007	ETCTN	Leukemia	Active	A Phase 1b/2 Study of Pinometostat in Combination with Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia with MLL Rearrangement	I/II	0/12	N/A	INTERVENTION
29	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	69/100	N/A	INTERVENTION
30	9782	LAO-NJ066	ETCTN	Miscellaneous and Metastatic Cancer	Active	A Phase 1 Study of Talazoparib (BMN 673) in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors	I	43/66	N/A	INTERVENTION
31	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	46/45	N/A	INTERVENTION
32	9875	LAO-MA036	ETCTN	Lymphoma	Active	Phase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL	II	22/50	N/A	INTERVENTION
33	9876	LAO-OH007	ETCTN	Breast Cancer	Active	Phase 1b Study of HSP90 Inhibitor, AT13387 in Combination with Paclitaxel in Patients with Advanced, Triple Negative Breast Cancer	I	24/33	N/A	INTERVENTION
34	9881	LAO-CT018	ETCTN	Breast Cancer;Gastrointestinal Cancer;Lung, Mediastinal, and Pleural Cancer	Active	A Phase 2 Study of Cediranib in Combination with Olaparib in Advanced Solid Tumors	II	111/126	N/A	INTERVENTION
35	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	6/47	N/A	INTERVENTION
36	A021502	ALLIANCE	NCTN	Gastrointestinal Cancer	Active	Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair	III	165/700	N/A	INTERVENTION
37	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	35/324	N/A	INTERVENTION
38	A041701	ALLIANCE	NCTN	Leukemia	Active	A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy	II/III	0/670	N/A	INTERVENTION
39	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	34/296	254	SCREENING,INTERVENTION
40	A191402CD	ALLIANCE	NCORP	Male Reproductive System Cancer	Active	Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men	III	148/172	N/A	INTERVENTION
41	A221701	ALLIANCE	NCORP	Miscellaneous and Metastatic Cancer	Active	Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches	III	0/279	N/A	INTERVENTION
42	EA2161	ECOG-ACRIN	NCTN	Gastrointestinal Cancer	Temporarily Closed to Accrual	A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)	II	13/40	N/A	INTERVENTION
43	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	46/345	N/A	INTERVENTION
44	EA5163	ECOG-ACRIN	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	EA5163/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 Analysis	III	0/846	N/A	INTERVENTION
45	EA6141	ECOG-ACRIN	NCTN	Skin Cancer	Temporarily Closed to Accrual	Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma	II/III	250/400	N/A	INTERVENTION
46	EA9161	ECOG-ACRIN	NCTN	Leukemia	Active	A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)	III	16/720	N/A	INTERVENTION
47	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	152/361	254	SCREENING,INTERVENTION
48	NHLBI-MDS	ECOG-ACRIN	NCORP	Leukemia	Active	The National Myelodysplastic Syndromes (MDS) Study	Other	N/A	N/A	OTHER
49	NRG-GU006	NRG	NCTN	Male Reproductive System Cancer	Active	A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer	II	64/324	N/A	INTERVENTION
50	RTOG-1119	NRG	NCTN	Breast Cancer	Active	Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination with Concurrent Lapatinib in Patients with Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG	II	137/143	N/A	INTERVENTION