History of Changes for Study: NCT01295827

Study of MK-3475 in Participants With Solid Tumors (P07990/MK-3475-001)

Latest version (submitted November 22, 2019) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	February 14, 2011	None (earliest Version on record)
2	March 10, 2011	Outcome Measures, Arms and Interventions, Study Status, Study Identification, Eligibility, Conditions and Sponsor/Collaborators
3	April 1, 2011	Recruitment Status, Study Status and Contacts/Locations
4	June 2, 2011	Study Status
5	July 28, 2011	Study Status
6	August 9, 2011	Study Status
7	September 29, 2011	Study Status
8	October 21, 2011	Arms and Interventions, Sponsor/Collaborators, Conditions, Study Status, Study Identification, Eligibility, Outcome Measures, Study Design and Study Description
9	November 30, 2011	Study Status and Contacts/Locations
10	December 29, 2011	Study Status and Contacts/Locations
11	January 4, 2012	Study Status and Contacts/Locations
12	February 29, 2012	Contacts/Locations and Study Status
13	April 17, 2012	Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Study Identification, Eligibility, Study Design and Study Description
14	April 24, 2012	Study Status
15	May 25, 2012	Study Status
16	June 8, 2012	Sponsor/Collaborators, Study Status and Study Identification
17	June 27, 2012	Contacts/Locations and Study Status
18	September 6, 2012	Arms and Interventions, Outcome Measures, Study Status, Study Design, Contacts/Locations, Eligibility, Study Description and Study Identification
19	December 4, 2012	Arms and Interventions, Outcome Measures, Study Status, Eligibility, Study Design, Study Description and Study Identification
20	December 13, 2012	Contacts/Locations and Study Status
21	December 14, 2012	Conditions and Study Status
22	January 23, 2013	Contacts/Locations and Study Status
23	February 8, 2013	Study Status and Contacts/Locations
24	February 25, 2013	Contacts/Locations and Study Status
25	March 22, 2013	Contacts/Locations and Study Status
26	May 9, 2013	Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures, Study Design, Study Description and Study Identification
27	May 16, 2013	Contacts/Locations and Study Status
28	June 28, 2013	Contacts/Locations and Study Status
29	July 16, 2013	Contacts/Locations and Study Status
30	August 2, 2013	Study Status and Contacts/Locations
31	September 3, 2013	Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design, Study Description and Study Identification
32	September 11, 2013	Contacts/Locations and Study Status
33	September 18, 2013	Contacts/Locations and Study Status
34	October 9, 2013	Contacts/Locations and Study Status
35	November 12, 2013	Study Status
36	November 15, 2013	Contacts/Locations and Study Status
37	December 3, 2013	Study Status and Contacts/Locations
38	December 17, 2013	Contacts/Locations and Study Status
39	December 30, 2013	Contacts/Locations and Study Status
40	January 9, 2014	Contacts/Locations and Study Status
41	January 27, 2014	Arms and Interventions, Study Description, Eligibility, Outcome Measures and Study Status
42	January 30, 2014	Study Status
43	February 20, 2014	Study Status, Study Identification, Contacts/Locations, Eligibility, Arms and Interventions, Study Design and Study Description
44	February 28, 2014	Contacts/Locations and Study Status
45	March 5, 2014	Contacts/Locations and Study Status
46	March 18, 2014	Study Status and Contacts/Locations
47	March 20, 2014	Contacts/Locations and Study Status
48	April 23, 2014	Study Status
49	April 30, 2014	Contacts/Locations and Study Status
50	June 2, 2014	Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures, Study Description and Study Identification
51	June 18, 2014	Contacts/Locations and Study Status
52	June 26, 2014	Contacts/Locations and Study Status
53	July 2, 2014	Study Status and Contacts/Locations
54	July 10, 2014	Recruitment Status, Study Status and Contacts/Locations
55	September 17, 2014	Study Status and References
56	January 30, 2015	Study Status
57	March 30, 2015	Study Status and Study Design
58	April 9, 2015	Study Status
59	August 26, 2015	Study Status
60	February 3, 2016	Study Status
61	April 5, 2016	Study Status
62	May 9, 2016	Arms and Interventions, Outcome Measures, Study Status, Study Identification, Eligibility and Study Description
63	June 16, 2016	References and Study Status
64	September 13, 2016	Study Status
65	December 2, 2016	Study Status
66	April 17, 2017	Study Status
67	August 18, 2017	Study Status
68	November 8, 2017	Study Status
69	January 28, 2018	Oversight, Study Status, Study Design and Study Identification
70	March 15, 2018	Study Status
71	June 19, 2018	Study Status
72	September 12, 2018	Study Status
73	November 19, 2018	Study Status and IPDSharing
74	December 19, 2018	Recruitment Status and Study Status
75	March 29, 2019	Arms and Interventions, Outcome Measures, Study Status, Eligibility and Study Description
	Results Submission Events
October 21, 2019		Returned after QC review: November 8, 2019
76	November 22, 2019	Outcome Measures, Study Status, Arms and Interventions, Study Description, Document Section, Results, Eligibility, Conditions, Oversight and Study Identification

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Study NCT01295827
Submitted Date: February 14, 2011 (v1)

Study Identification


Unique Protocol ID:	P07990
Brief Title:	Study of MK-3475 in Participants With Solid Tumors (P07990/MK-3475-001)
Official Title:	Phase I Study of Single Agent MK-3475 in Patients With Solid Tumors
Secondary IDs:	MK-3475-001 [Merck study number]

Study Status


Record Verification:	February 2011
Overall Status:	Not yet recruiting
Study Start:	March 2011
Primary Completion:	April 2012 [Anticipated]
Study Completion:	March 2013 [Anticipated]

First Submitted:	February 10, 2011
First Submitted that Met QC Criteria:	February 14, 2011
First Posted:	February 15, 2011 [Estimate]

Last Update Submitted that Met QC Criteria:	February 14, 2011
Last Update Posted:	February 15, 2011 [Estimate]

Study Description


Brief Summary:	In Part 1 of this study, the dose of intravenous (IV) MK-3475 will be escalated to find the maximum tolerated dose (MTD) for participants with locally advanced or metastatic carcinoma. Part 2 of the study will explore the efficacy of the drug at the MTD in participants with advanced melanoma (MEL) or renal cell carcinoma (RCC).
Detailed Description:

Conditions


Conditions:	Cancer Solid Tumors
Keywords:	Melanoma Renal cell carcinoma Carcinoma Cancer Advanced cancer Metastatic cancer Metastatic melanoma Metastatic renal cell carcinoma

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	5
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	32 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: MK-3475 1 mg/kg	Drug: MK-3475 IV infusion over 30 minutes on Day 1 of each cycle, at doses of 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment. Other Names: SCH900475
Experimental: MK-3475 3 mg/kg	Drug: MK-3475 IV infusion over 30 minutes on Day 1 of each cycle, at doses of 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment. Other Names: SCH900475
Experimental: MK-3475 10 mg/kg	Drug: MK-3475 IV infusion over 30 minutes on Day 1 of each cycle, at doses of 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment. Other Names: SCH900475
Experimental: MK-3475 at MTD for MEL	Drug: MK-3475 IV infusion over 30 minutes on Day 1 of each cycle, at doses of 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment. Other Names: SCH900475
Experimental: MK-3475 at MTD for RCC	Drug: MK-3475 IV infusion over 30 minutes on Day 1 of each cycle, at doses of 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment. Other Names: SCH900475

Outcome Measures


Primary Outcome Measures:
1.	Number of participants experiencing dose-limiting toxicities. [ Time Frame: Cycle 1 (28 days) ]
2.	Number of participants experiencing clinical and laboratory adverse events (AEs). [ Time Frame: First dose to 30 days post last dose ]
Secondary Outcome Measures:
1.	The area under the curve (AUC) of plasma concentration of drug against time after administration of MK-3475. [ Time Frame: Pre-dose, 30 minutes, 6, 24, and 48 hours post-dose, and on Days 8, 15, 22, and 29 of Cycle 1; pre- and post-dose on Days 1 and 14 of every other subsequent 14-day cycle up to 12 months ]
2.	Maximum concentration (Cmax) after first dose interval of MK-3475. [ Time Frame: Pre-dose, 30 minutes, 6, 24, and 48 hours post-dose, and on Days 8, 15, 22, and 29 of Cycle 1; pre- and post-dose on Days 1 and 14 of every other subsequent 14-day cycle up to 12 months ]
3.	Time at which maximum concentration (Tmax) occurs for MK-3475 [ Time Frame: Pre-dose, 30 minutes, 6, 24, and 48 hours post-dose, and on Days 8, 15, 22, and 29 of Cycle 1; pre- and post-dose on Days 1 and 14 of every other subsequent 14-day cycle up to 12 months ]
4.	Lowest plasma concentration (C[trough]) of MK-3475 [ Time Frame: Pre-dose, 30 minutes, 6, 24, and 48 hours post-dose, and on Days 8, 15, 22, and 29 of Cycle 1; pre- and post-dose on Days 1 and 14 of every other subsequent 14-day cycle up to 12 months ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion criteria Histological or cytological diagnosis of MEL or any type of carcinoma, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. In Part B of the study, only histological diagnoses of MEL or RCC are eligible for participation. Failure of established standard medical anti-cancer therapies for a given tumor type or intolerance to such therapy. In Part B of the study. MEL or RCC must be measurable by imaging. Performance status of ≥2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. Adequate organ function. Exclusion criteria Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events caused by therapy administered more than 4 weeks prior to first dose. Participation in a study of an investigational agent or using an investigational device within 30 days of administration of MK-3475. Other form(s) of antineoplastic therapy anticipated during the period of the study, excluding luteinizing hormone-releasing hormone (LHRH) agonists. Chronic systemic steroid therapy at doses >10 mg/day, or on any other form of immunosuppressive medication. Chronic anti-coagulation treatment with warfarin. History of a hematologic malignancy, primary brain tumor or sarcoma, unless no evidence of that disease for 5 years. Active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previous severe hypersensitivity reaction to another monoclonal antibody (mAb). Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulatory pathways). Active infection requiring therapy. Human Immunodeficiency Virus (HIV) positive Hepatitis B or Hepatitis C virus positive. Regular use of illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). Symptomatic ascites or pleural effusion. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

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