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	20/40	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	48/48	N/A	INTERVENTION
3	10057	LAO-MA036	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	45/68	N/A	INTERVENTION
4	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	15/60	N/A	INTERVENTION
5	10184	LAO-NCI	ETCTN	Head and Neck Cancer	Active	Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)	I	1/34	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	6/18	N/A	INTERVENTION
7	10219	LAO-MA036	ETCTN	Myeloma	Active	Phase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor (CB-839 HCl) in Combination with Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma	I	13/36	N/A	INTERVENTION
8	10264	LAO-CT018	ETCTN	Leukemia	Active	The PRIME Trial: PARP Inhibition in IDH Mutant Effectiveness Trial. A Phase II Study of Olaparib in Isocitrate Dehydrogenase (IDH) Mutant Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome	II	2/94	3	SCREENING,INTERVENTION
9	10273	LAO-CA043	ETCTN	Leukemia	Active	A Phase I Study of M3814 in Combination with MEC in Patients with Relapsed or Refractory Acute Myeloid Leukemia	I	4/48	N/A	INTERVENTION
10	10276	LAO-11030	ETCTN	Gastrointestinal Cancer;Miscellaneous and Metastatic Cancer	Active	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	8/30	N/A	INTERVENTION
11	10291	LAO-MA036	ETCTN	Breast Cancer	Active	A Phase 1b Study of M6620 in Combination with Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer	I	3/42	N/A	INTERVENTION
12	10296	LAO-TX035	ETCTN	Breast Cancer	Active	Phase Ib/II Trial of Copanlisib in Combination with Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) with PIK3CA Mutation or PTEN Mutation	I/II	0/12	N/A	INTERVENTION
13	10300	LAO-CT018	ETCTN	Leukemia	Temporarily Closed to Accrual	BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid Leukemia	II	0/124	N/A	INTERVENTION
14	10301	LAO-CT018	ETCTN	Male Reproductive System Cancer	Active	A Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, & Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)	I/II	3/24	N/A	INTERVENTION
15	10315	LAO-CT018	ETCTN	Endocrine Cancer	Active	A Phase 2 Study of XL184 (Cabozantinib) in Combination with Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas	II	2/30	N/A	INTERVENTION
16	10334	LAO-CT018	ETCTN	Leukemia	Temporarily Closed to Accrual	BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2 (BLAST MRD AML-2): A Randomized Phase 2 Study of the Venetoclax, Azacitadine, and Pembrolizumab (VAP) Versus Venetoclax and Azacitadine as First Line Therapy in Older Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible or Who Refuse Intensive Chemotherapy	II	0/76	N/A	INTERVENTION
17	9892	LAO-PA015	ETCTN	AIDS-related Malignancy and Condition;Female Reproductive System Cancer	Active	Phase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination with Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal Cancer	I	5/64	N/A	INTERVENTION
18	9950	LAO-MD017	ETCTN	Head and Neck Cancer	Active	A Phase I Study of M6620 (VX-970) in Combination with Cisplatin and XRT in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)	I	27/45	N/A	INTERVENTION
19	9979	LAO-MD017	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	8/47	N/A	INTERVENTION
20	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	149/341	N/A	INTERVENTION
21	A041703	ALLIANCE	NCTN	Leukemia	Active	A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease	II	23/64	N/A	INTERVENTION
22	A171901	ALLIANCE	NCORP	Lung, Mediastinal, and Pleural Cancer	Active	Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)	II	1/100	N/A	INTERVENTION
23	A221702	ALLIANCE	NCORP	Breast Cancer	Active	ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence after Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection with and without Axillary Reverse Mapping	III	146/516	N/A	INTERVENTION
24	DCP-001	DCP	NCORP	Hematopoietic Neoplasm (excluding Leukemia, Lymphoma and Myeloma);Miscellaneous and Metastatic Cancer	Active	Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)	Other	N/A	N/A	OTHER
25	EA2182	ECOG-ACRIN	NCTN	Gastrointestinal Cancer	Active	A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)	II	18/252	18	SCREENING,INTERVENTION
26	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	242/846	N/A	INTERVENTION
27	EA6141	ECOG-ACRIN	NCTN	Skin Cancer	Active	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	260/600	N/A	INTERVENTION
28	EA8134	ECOG-ACRIN	NCTN	Male Reproductive System Cancer	Active	InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)	III	39/200	N/A	INTERVENTION
29	EA9181	ECOG-ACRIN	NCTN	Leukemia	Active	A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults	III	0/348	0	SCREENING,INTERVENTION
30	EAY131	ECOG-ACRIN	NCTN	Lymphoma;Miscellaneous and Metastatic Cancer;Myeloma	Active	Molecular Analysis for Therapy Choice (MATCH)	II	1146/1425	7053	SCREENING,INTERVENTION
31	LUNGMAP	SWOG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)	II	N/A	1757	SCREENING
32	NRG-BN007	NRG	NCTN	CNS Cancer (Primary tumor)	Active	A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma	II/III	8/485	14	SCREENING,INTERVENTION
33	NRG-GI004	NRG	NCTN	Gastrointestinal Cancer	Temporarily Closed to Accrual	Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer	III	64/200	N/A	INTERVENTION
34	NRG-GI006	NRG	NCTN	Gastrointestinal Cancer	Active	Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer	III	44/300	N/A	INTERVENTION
35	NRG-GY020	NRG	NCTN	Female Reproductive System Cancer	Active	A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer	III	24/168	N/A	INTERVENTION
36	NRG-GY022	NRG	NCTN	Miscellaneous and Metastatic Cancer	Active	Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin	I	74/250	N/A	INTERVENTION
37	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	296/491	N/A	INTERVENTION
38	S1602	SWOG	NCTN	Urothelial/ Bladder Cancer	Active	A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-Muscle Invasive Bladder Cancer	III	967/969	N/A	INTERVENTION
39	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	35/122	202	SCREENING,INTERVENTION
40	S1701	SWOG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma	II	10/66	N/A	INTERVENTION
41	S1914	SWOG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC	III	5/480	N/A	INTERVENTION
42	S1933	SWOG	NCTN	Lung, Mediastinal, and Pleural Cancer	Active	A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status	II	0/47	N/A	INTERVENTION
43	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	3/21	N/A	INTERVENTION
44	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
45	10076	LAO-TX035	ETCTN	Myeloma	Active	A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination with Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma	I	9/40	N/A	INTERVENTION
46	10104	LAO-11030	ETCTN	Female Reproductive System Cancer	Temporarily Closed to Accrual	A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial Cancer	II	82/84	N/A	INTERVENTION
47	10146	LAO-CT018	ETCTN	Breast Cancer	Active	Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients with Metastatic Triple Negative Breast Cancer	II	0/70	N/A	INTERVENTION
48	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	39/96	N/A	INTERVENTION
49	10183	EDDO-IL036	ETCTN	Urothelial/ Bladder Cancer	Active	A Pilot Study of Tazemetostat and Pembrolizumab (MK-3475) in Advanced Urothelial Carcinoma	I/II	6/30	N/A	INTERVENTION
50	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	12/312	N/A	INTERVENTION