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	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	19/40	N/A	INTERVENTION
2	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	50/90	N/A	INTERVENTION
3	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	32/49	N/A	INTERVENTION
4	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	24/96	N/A	INTERVENTION
5	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
6	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
7	10276	LAO-NJ066	ETCTN	Gastrointestinal Cancer;Miscellaneous and Metastatic Cancer	Temporarily Closed to Accrual	A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies	I/II	0/30	N/A	INTERVENTION
8	10302	LAO-NJ066	ETCTN	Breast Cancer	Active	Phase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast Cancer	II	0/70	N/A	INTERVENTION
9	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
10	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	255/420	N/A	INTERVENTION
11	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	71/1046	N/A	INTERVENTION
12	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
13	A211701	ALLIANCE	NCORP	N/A	Active	A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort	III	N/A	N/A	OTHER
14	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
15	EA2165	ECOG-ACRIN	NCTN	Gastrointestinal Cancer	Active	A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer	II	131/200	N/A	INTERVENTION
16	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
17	EA6174	ECOG-ACRIN	NCTN	Skin Cancer	Active	STAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab, a Phase III Trial	III	37/500	N/A	INTERVENTION
18	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	379/766	429	SCREENING,INTERVENTION
19	EA8171	ECOG-ACRIN	NCTN	Male Reproductive System Cancer	Active	Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer	II	121/852	N/A	INTERVENTION
20	EA9131	ECOG-ACRIN	NCORP	Leukemia	Active	A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)	II	139/200	N/A	INTERVENTION
21	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	68/99	N/A	INTERVENTION
22	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
23	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	258/324	N/A	INTERVENTION
24	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	1436/1636	N/A	INTERVENTION
25	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	186/368	N/A	INTERVENTION
26	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	35/56	N/A	INTERVENTION
27	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	37/987	N/A	INTERVENTION
28	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
29	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
30	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	14/24	N/A	INTERVENTION
31	10075	LAO-CA043	ETCTN	Leukemia	Active	A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia	I	15/48	N/A	INTERVENTION
32	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	6/18	N/A	INTERVENTION
33	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	24/41	N/A	INTERVENTION
34	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
35	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	6/24	N/A	INTERVENTION
36	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	9/60	N/A	INTERVENTION
37	10193	LAO-MN026	ETCTN	Lymphoma	Active	Phase 2 Study of Copanlisib in Combination with Nivolumab in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal Large B-Cell Lymphoma	II	1/106	N/A	INTERVENTION
38	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	3/102	N/A	INTERVENTION
39	10266	LAO-NJ066	ETCTN	Lung, Mediastinal, and Pleural Cancer	Temporarily Closed to Accrual	A Phase 2 Study of MLN4924 (Pevonedistat) in Combination with Carboplatin and Paclitaxel in Advanced NSCLC Previously Treated with Immunotherapy	II	0/25	N/A	INTERVENTION
40	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	261/700	N/A	INTERVENTION
41	A021703	ALLIANCE	NCTN	Gastrointestinal Cancer	Active	Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)	III	6/402	N/A	INTERVENTION
42	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	87/324	N/A	INTERVENTION
43	A051701	ALLIANCE	NCTN	Lymphoma	Active	Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas	II/III	12/367	N/A	INTERVENTION
44	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
45	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	83/88	N/A	INTERVENTION
46	A221505	ALLIANCE	NCORP	Breast Cancer	Active	RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction	III	421/880	N/A	INTERVENTION
47	AREN1721	COG	NCTN	Kidney Cancer	Active	A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups	II	6/87	N/A	INTERVENTION
48	CITN-12	CITN	MISCELLANEOUS	AIDS-related Malignancy and Condition;Gastrointestinal Cancer;Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Lung, Mediastinal, and Pleural Cancer;Lymphoma;Miscellaneous and Metastatic Cancer;Skin Cancer	Active	Phase I Study of MK-3475 (Pembrolizumab) in Patients with Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm	I	39/63	N/A	INTERVENTION
49	E4512	ECOG-ACRIN	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein	III	100/168	N/A	INTERVENTION
50	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 Breast Cancer following Neoadjuvant Chemotherapy	III	319/562	448	SCREENING,INTERVENTION