Protocol list

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.

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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	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	25/48	N/A	INTERVENTION
2	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	1/21	N/A	INTERVENTION
3	10075	LAO-CA043	ETCTN	Leukemia	Active	A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia	I	9/48	N/A	INTERVENTION
4	10096	LAO-CT018	ETCTN	Male Reproductive System Cancer	Temporarily Closed to Accrual	A Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE)	I/II	3/18	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	10204	LAO-TX035	ETCTN	Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic Cancer	Active	A Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)	I	0/312	N/A	INTERVENTION
8	10216	LAO-OH007	ETCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Phase I/II Study of AZD9291(Osimertinib) and CB-839 HCl in Patients with EGFR Mutant Non-Small Cell Lung Cancer	I/II	0/18	N/A	INTERVENTION
9	10249	LAO-MD017	ETCTN	Myeloma	Active	MLN9708 (Ixazomib) and MLN4924 (Pevonedistat) in Relapsed/Refractory Multiple Myeloma Patients: A Phase 1b Trial	I	0/66	N/A	INTERVENTION
10	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	13/209	N/A	INTERVENTION
11	9837	LAO-CA043	ETCTN	Lung, Mediastinal, and Pleural Cancer;Miscellaneous and Metastatic Cancer	Active	Phase I Study of TRC102 in Combination with Cisplatin and Pemetrexed in Patients with Advanced Solid Tumors / Phase II Study of TRC102 with Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin	I/II	25/58	N/A	INTERVENTION
12	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	14/36	N/A	INTERVENTION
13	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	23/51	N/A	INTERVENTION
14	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	71/90	N/A	INTERVENTION
15	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	17/395	N/A	INTERVENTION
16	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
17	NRG-CC007CD	NRG	NCORP	Male Reproductive System Cancer	Active	Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy	Other	0/504	0	SCREENING,INTERVENTION
18	NRG-GI002	NRG	NCTN	Gastrointestinal Cancer	Temporarily Closed to Accrual	A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer	II	363/348	N/A	INTERVENTION
19	PBTC-049	PBTC	MISCELLANEOUS	CNS Cancer (Primary tumor)	Temporarily Closed to Accrual	A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, or Diffuse Intrinsic Pontine Glioma	I	2/36	N/A	INTERVENTION
20	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	173/368	N/A	INTERVENTION
21	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	240/491	N/A	INTERVENTION
22	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	3028/3960	N/A	INTERVENTION
23	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	25/77	N/A	INTERVENTION
24	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	6/200	N/A	INTERVENTION
25	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	17/64	N/A	INTERVENTION
26	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
27	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
28	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	8/106	N/A	INTERVENTION
29	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
30	10183	EDDO-IL036	MISCELLANEOUS	Urothelial/ Bladder Cancer	Active	A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma	I/II	N/A	N/A	OTHER
31	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	2/12	N/A	INTERVENTION
32	10246	LAO-11030	ETCTN	Leukemia	Active	A Phase 1 Study of MLN4924 (Pevonedistat) and Belinostat in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome	I	0/45	N/A	INTERVENTION
33	9149	LAO-NCI	ETCTN	Miscellaneous and Metastatic Cancer	Active	Molecular Profiling-Based Assignment of Cancer Therapy for Patients with Advanced Solid Tumors	II	200/120	206	SCREENING,INTERVENTION
34	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	74/139	N/A	INTERVENTION
35	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	71/80	N/A	INTERVENTION
36	9782	LAO-NJ066	ETCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	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
37	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	50/45	N/A	INTERVENTION
38	9875	LAO-MA036	ETCTN	Lymphoma	Active	Phase 2 Study of AT13387 (onalespib) in ALK+ ALCL, MCL, and BCL-6+ DLBCL	II	23/50	N/A	INTERVENTION
39	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
40	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	113/126	N/A	INTERVENTION
41	A011202	ALLIANCE	NCTN	Breast Cancer	Temporarily Closed to Accrual	A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy	III	1543/1576	3353	SCREENING,INTERVENTION
42	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	188/700	N/A	INTERVENTION
43	A031702	ALLIANCE	NCTN	Kidney Cancer;Male Reproductive System Cancer;Urothelial/ Bladder Cancer	Active	Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors	II	3/171	N/A	INTERVENTION
44	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	46/324	N/A	INTERVENTION
45	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	10/670	N/A	INTERVENTION
46	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
47	A091802	ALLIANCE	NCTN	Skin Cancer	Active	Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)	II	0/59	N/A	INTERVENTION
48	A191402CD	ALLIANCE	NCORP	Male Reproductive System Cancer	Active	Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men	III	153/172	N/A	INTERVENTION
49	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
50	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