History of Changes for Study: NCT01848834

Study of MK-3475 in Participants With Advanced Solid Tumors (MK-3475-012)

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Study Record Versions

Version	Submitted Date	Changes
1	May 3, 2013	None (earliest Version on record)
2	May 8, 2013	Recruitment Status, Outcome Measures, Study Status and Contacts/Locations
3	May 16, 2013	Contacts/Locations and Study Status
4	July 10, 2013	Study Status and Contacts/Locations
5	July 30, 2013	Study Status and Contacts/Locations
6	August 2, 2013	Study Status and Contacts/Locations
7	August 12, 2013	Contacts/Locations and Study Status
8	September 13, 2013	Outcome Measures, Arms and Interventions, Study Status, Eligibility, Study Design and Study Description
9	September 25, 2013	Study Status
10	September 30, 2013	Contacts/Locations and Study Status
11	October 8, 2013	Study Status and Contacts/Locations
12	October 18, 2013	Contacts/Locations and Study Status
13	November 14, 2013	Study Status
14	December 5, 2013	Study Status and Contacts/Locations
15	December 18, 2013	Contacts/Locations and Study Status
16	December 30, 2013	Contacts/Locations and Study Status
17	February 5, 2014	Contacts/Locations, Study Status and Eligibility
18	February 19, 2014	Arms and Interventions, Study Status and Study Identification
19	February 28, 2014	Contacts/Locations and Study Status
20	March 5, 2014	Study Status and Contacts/Locations
21	March 13, 2014	Contacts/Locations and Study Status
22	April 4, 2014	Study Status and Study Identification
23	April 21, 2014	Outcome Measures, Arms and Interventions, Study Status, Study Description, Eligibility and Study Design
24	April 30, 2014	Arms and Interventions, Study Description and Study Status
25	June 3, 2014	Arms and Interventions, Outcome Measures, Study Description, Study Status and Study Identification
26	July 15, 2014	Study Status
27	July 22, 2014	Contacts/Locations and Study Status
28	July 30, 2014	Contacts/Locations and Study Status
29	September 5, 2014	Study Status
30	November 6, 2014	Recruitment Status, Study Status and Contacts/Locations
31	January 21, 2015	Study Status
32	March 24, 2015	Study Design and Study Status
33	April 9, 2015	Study Status
34	June 29, 2015	Study Status
35	September 28, 2015	Study Status
36	November 11, 2015	Outcome Measures, Arms and Interventions, Study Status and Eligibility
37	January 13, 2016	Study Status
38	April 7, 2016	Study Status
39	June 16, 2016	References and Study Status
40	August 26, 2016	Study Status and References
41	November 14, 2016	Study Status
42	December 15, 2016	Study Status
43	February 8, 2017	Study Status and References
44	April 7, 2017	Study Status, Outcome Measures, Arms and Interventions, Study Description, Results, IPDSharing, Contacts/Locations, Eligibility, Conditions and Study Identification
45	November 8, 2017	Study Status
46	December 18, 2017	Oversight, Study Status, Study Description and Study Identification
47	February 15, 2018	Study Status
48	January 28, 2019	Study Status and IPDSharing
49	December 11, 2019	Study Status
50	July 7, 2020	Recruitment Status and Study Status
51	May 28, 2021	Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow, Arms and Interventions, Study Status, Document Section, Eligibility, Study Description and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	3475-012
Brief Title:	Study of MK-3475 in Participants With Advanced Solid Tumors (MK-3475-012)
Official Title:	A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors
Secondary IDs:	2012-005771-14 [EudraCT Number]

Study Status


Record Verification:	May 2013
Overall Status:	Not yet recruiting
Study Start:	May 2013
Primary Completion:	January 2015 [Anticipated]
Study Completion:	January 2015 [Anticipated]

First Submitted:	May 3, 2013
First Submitted that Met QC Criteria:	May 3, 2013
First Posted:	May 8, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	May 3, 2013
Last Update Posted:	May 8, 2013 [Estimate]

Sponsor/Collaborators


Sponsor:	Merck Sharp & Dohme LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description


Brief Summary:	This study is being done to investigate the safety, tolerability and anti-tumor activity of MK-3475 in participants with advanced triple negative breast cancer (TNBC), advanced head and neck cancer, or advanced urothelial cancer.
Detailed Description:

Conditions


Conditions:	Cancer Solid Tumor
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	90 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Triple negative breast cancer Participants will receive MK-3475, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)	Drug: MK-3475 Other Names: SCH 900475
Experimental: Head/neck cancer Participants will receive MK-3475, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)	Drug: MK-3475 Other Names: SCH 900475
Experimental: Urothelial tract cancer Participants will receive MK-3475, 10 mg/kg, intravenously (IV) once every 2 weeks, and will continue to receive drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years)	Drug: MK-3475 Other Names: SCH 900475

Outcome Measures


Primary Outcome Measures:
1.	Number of participants experiencing adverse events [ Time Frame: From first dose to 90 days after last dose of study treatment (up to 2 years) ]
2.	Number of participants discontinuing from study treatment due to adverse events [ Time Frame: From first dose up to last dose of study treatment (up to 2 years) ]
3.	Number of participants with TNBC, head and neck, or urothelial cancer who achieve a clinically meaningful overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Baseline and every 8 weeks, up to 2 years ]
Secondary Outcome Measures:
1.	Number of participants with head and neck cancer and who are human papilloma virus (HPV)-positive who achieve a clinically meaningful ORR per RECIST 1.1 criteria [ Time Frame: Baseline and every 8 weeks, up to 2 years ]
2.	Number of participants with log fold change from baseline in cytokines >1 [ Time Frame: Baseline and Week 8 ]
3.	Number of participants with TNBC, head and neck, or urothelial cancer who achieve a clinically meaningful ORR per immune-related response criteria (irRC) [ Time Frame: Baseline and every 8 weeks, up to 2 years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Histologically or cytologically-confirmed diagnosis of tumor that is recurrent, metastatic, or persistent: For Cohort A - triple negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 [HER2] negative) For Cohort B - squamous cell carcinoma of the head and neck (including HPV-positive head and neck squamous cell cancer). For Cohort C - urothelial tract cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell or non-transitional cell histology) Any number of prior treatment regimens Measurable disease Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment Exclusion Criteria: Currently participating in/has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment Monoclonal antibody treatment within 4 weeks prior to study Day 1 or not recovered from adverse events due to agents administered more than 4 weeks earlier Chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Active autoimmune disease or documented history of autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents Evidence of interstitial lung disease Active infection requiring systemic therapy Known psychiatric or substance abuse disorders Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody Known history of human immunodeficiency virus (HIV)

Contacts/Locations


Locations:

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: