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	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	67/72	N/A	INTERVENTION
2	10014	LAO-11030	ETCTN	Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic Cancer	Active	A Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumor Malignancies	Pilot	17/40	N/A	INTERVENTION
3	10017	EDDO-NY158	MISCELLANEOUS	Female Reproductive System Cancer	Temporarily Closed to Accrual	A Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer	I/II	12/75	N/A	INTERVENTION
4	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	41/90	N/A	INTERVENTION
5	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	22/49	N/A	INTERVENTION
6	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	82/84	N/A	INTERVENTION
7	10106	LAO-MD017	ETCTN	Lymphoma	Active	A Phase I and Randomized Phase II Study of KW-0761 (Mogamulizumab) and MK-3475 (Pembrolizumab) in Relapsed and Refractory Lymphomas	I/II	4/76	N/A	INTERVENTION
8	10150	LAO-11030	ETCTN	Female Reproductive System Cancer	Active	A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer	I/II	15/96	N/A	INTERVENTION
9	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
10	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
11	10231	DCTD	NCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study	Pilot	N/A	N/A	OTHER
12	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	9/132	N/A	INTERVENTION
13	9979	LAO-MN026	ETCTN	Miscellaneous and Metastatic Cancer	Active	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
14	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	217/420	N/A	INTERVENTION
15	A031704	ALLIANCE	NCTN	Kidney Cancer	Active	PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]	III	17/1046	N/A	INTERVENTION
16	A191402CD	ALLIANCE	NCORP	Male Reproductive System Cancer	Active	Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men	III	158/172	N/A	INTERVENTION
17	A211401	ALLIANCE	NCORP	Lung, Mediastinal, and Pleural Cancer	Active	Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes	III	16/783	N/A	INTERVENTION
18	A211601	ALLIANCE	NCORP	Breast Cancer	Active	Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502	III	N/A	N/A	OTHER
19	ACCL16N1CD	COG	NCORP	Leukemia	Active	Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)	Other	N/A	N/A	OTHER
20	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
21	EA6174	ECOG-ACRIN	NCTN	Skin Cancer	Active	STAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III Trial	III	21/500	N/A	INTERVENTION
22	EA8143	ECOG-ACRIN	NCTN	Kidney Cancer	Active	A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)	III	290/766	337	SCREENING,INTERVENTION
23	EA8171	ECOG-ACRIN	NCTN	Male Reproductive System Cancer	Active	Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer	II	46/852	N/A	INTERVENTION
24	EA9131	ECOG-ACRIN	NCORP	Leukemia	Active	A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)	II	119/200	N/A	INTERVENTION
25	EAE161	ECOG-ACRIN	NCTN	Female Reproductive System Cancer	Temporarily Closed to Accrual	Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab and Paclitaxel Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma	II	1/184	3	SCREENING,INTERVENTION
26	EAI142	ECOG-ACRIN	NCTN	Breast Cancer	Active	[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast Cancer	II	62/99	N/A	INTERVENTION
27	NRG-BR002	NRG	NCTN	Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	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	129/360	N/A	INTERVENTION
28	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	165/324	N/A	INTERVENTION
29	NSABP-B-51	NRG	NCTN	Breast Cancer	Active	A 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 Chemotherapy	III	1341/1636	N/A	INTERVENTION
30	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	180/368	N/A	INTERVENTION
31	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	3434/3960	N/A	INTERVENTION
32	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	28/56	N/A	INTERVENTION
33	S1826	SWOG	NCTN	Lymphoma	Active	A 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 Lymphoma	III	5/987	N/A	INTERVENTION
34	10015	EDDO-MI014	MISCELLANEOUS	Soft Tissue Cancer/Sarcoma	Active	A Non-Randomized, Open-Label, Phase 2 Study of Trametinib in Patients with Unresectable or Metastatic Epithelioid Hemangioendothelioma	II	41/29	N/A	INTERVENTION
35	10057	LAO-NJ066	ETCTN	Female Reproductive System Cancer;Lymphoma;Skin Cancer	Temporarily Closed to Accrual	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	38/68	N/A	INTERVENTION
36	10061	LAO-PA015	ETCTN	Miscellaneous and Metastatic Cancer	Active	A Phase 1 Study of MK-3475 (Pembrolizumab) in Combination with Recombinant Interleukin-12 in Patients with Solid Tumors	I	14/36	N/A	INTERVENTION
37	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	11/24	N/A	INTERVENTION
38	10075	LAO-CA043	ETCTN	Leukemia	Active	A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia	I	12/48	N/A	INTERVENTION
39	10096	LAO-CT018	ETCTN	Male Reproductive System Cancer	Active	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	5/18	N/A	INTERVENTION
40	10145	LAO-NCI	ETCTN	Lymphoma;Miscellaneous and Metastatic Cancer	Active	Phase Ib Combination Study of Copanlisib and Nivolumab in Advanced Solid Tumors and Lymphomas	I	20/41	N/A	INTERVENTION
41	10146	LAO-NC010	ETCTN	Breast Cancer	Temporarily Closed to Accrual	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
42	10166	LAO-MD017	ETCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung Cancer	II	5/24	N/A	INTERVENTION
43	10170	LAO-CT018	ETCTN	Kidney Cancer;Miscellaneous and Metastatic Cancer	Active	A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies	II	5/60	N/A	INTERVENTION
44	10217	LAO-TX035	ETCTN	Miscellaneous and Metastatic Cancer	Active	A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients with Advanced Solid Tumors	I	0/102	N/A	INTERVENTION
45	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	56/45	N/A	INTERVENTION
46	9924	LAO-CA043	ETCTN	Lymphoma	Active	A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)	I	19/44	N/A	INTERVENTION
47	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	221/700	N/A	INTERVENTION
48	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	70/324	N/A	INTERVENTION
49	A071401	ALLIANCE	NCTN	CNS Cancer (Primary tumor)	Temporarily Closed to Accrual	Phase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 Mutations	II	40/124	322	SCREENING,INTERVENTION
50	A171601	ALLIANCE	NCORP	Breast Cancer	Active	A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer	II	51/88	N/A	INTERVENTION