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	47/48	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	10075	LAO-CA043	ETCTN	Leukemia	Active	A Phase 1B Study of KRT-232 (AMG-232) in Combination with Decitabine in Acute Myeloid Leukemia	I	23/48	N/A	INTERVENTION
5	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
6	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
7	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	4/18	N/A	INTERVENTION
8	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	12/36	N/A	INTERVENTION
9	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	2	SCREENING,INTERVENTION
10	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	3/48	N/A	INTERVENTION
11	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
12	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	2/42	N/A	INTERVENTION
13	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
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	1/24	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	1/30	N/A	INTERVENTION
16	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
17	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	26/45	N/A	INTERVENTION
18	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
19	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	19/64	N/A	INTERVENTION
20	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	0/100	N/A	INTERVENTION
21	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: MIST (My Individualized Stomatitis Treatment)	III	39/279	N/A	INTERVENTION
22	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	119/516	N/A	INTERVENTION
23	AGCT1532	COG	NCTN	Germ Cell Cancer	Active	A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors	III	39/150	N/A	INTERVENTION
24	CCTG CE.7	CCTG	NCTN	Miscellaneous and Metastatic Cancer	Active	A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) plus Memantine for 5-15 Brain Metastases	III	37/206	N/A	INTERVENTION
25	CCTG MA.39	CCTG	NCTN	Breast Cancer	Active	Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer	III	344/2140	697	SCREENING,INTERVENTION
26	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
27	EA1183	ECOG-ACRIN	NCTN	Breast Cancer	Active	FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer, FEATURE	II	3/134	N/A	INTERVENTION
28	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	223/846	N/A	INTERVENTION
29	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	255/600	N/A	INTERVENTION
30	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
31	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
32	EAY131	ECOG-ACRIN	NCTN	Lymphoma;Miscellaneous and Metastatic Cancer;Myeloma	Active	Molecular Analysis for Therapy Choice (MATCH)	II	1141/1425	7042	SCREENING,INTERVENTION
33	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	1694	SCREENING
34	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	3/485	5	SCREENING,INTERVENTION
35	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	41/300	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	62/250	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	293/491	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	908/969	N/A	INTERVENTION
39	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	43/47	N/A	INTERVENTION
40	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	34/122	197	SCREENING,INTERVENTION
41	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	9/66	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	7/40	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	37/96	N/A	INTERVENTION
49	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	10/312	N/A	INTERVENTION
50	10231	DCTD	NCTN	Miscellaneous and Metastatic Cancer	Active	NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study	Pilot	N/A	N/A	OTHER