History of Changes for Study: NCT01844505

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate-067)

Latest version (submitted January 5, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	April 30, 2013	None (earliest Version on record)
2	June 25, 2013	Recruitment Status, Study Status and Contacts/Locations
3	August 12, 2013	Contacts/Locations and Study Status
4	August 30, 2013	Contacts/Locations and Study Status
5	September 17, 2013	Study Status
6	September 30, 2013	Contacts/Locations and Study Status
7	October 31, 2013	Contacts/Locations, Study Status, Study Identification and Study Description
8	November 28, 2013	Contacts/Locations and Study Status
9	December 31, 2013	Contacts/Locations and Study Status
10	January 17, 2014	Study Status and Eligibility
11	January 31, 2014	Contacts/Locations and Study Status
12	February 26, 2014	Contacts/Locations and Study Status
13	April 1, 2014	Recruitment Status, Contacts/Locations and Study Status
14	May 2, 2014	Study Status
15	May 7, 2014	Contacts/Locations, Study Status and References
16	May 27, 2014	Study Status
17	June 12, 2014	Study Status
18	June 25, 2014	Study Status
19	July 9, 2014	Study Status
20	July 23, 2014	Contacts/Locations and Study Status
21	August 14, 2014	Study Status, Outcome Measures and Study Description
22	September 15, 2014	Study Status and Contacts/Locations
23	September 22, 2014	Study Status
24	October 13, 2014	Contacts/Locations and Study Status
25	October 30, 2014	Contacts/Locations and Study Status
26	November 13, 2014	Study Status
27	November 20, 2014	Contacts/Locations and Study Status
28	December 5, 2014	Contacts/Locations and Study Status
29	December 31, 2014	Contacts/Locations and Study Status
30	January 27, 2015	Contacts/Locations and Study Status
31	February 6, 2015	Study Status
32	February 19, 2015	Study Status
33	March 5, 2015	Study Status
34	March 23, 2015	Contacts/Locations and Study Status
35	April 13, 2015	Study Status
36	April 20, 2015	Study Status
37	May 6, 2015	Study Status and Contacts/Locations
38	May 20, 2015	Study Status
39	June 3, 2015	Study Status
40	June 22, 2015	Study Status
41	July 3, 2015	Study Status
42	July 17, 2015	Contacts/Locations and Study Status
43	August 6, 2015	Contacts/Locations and Study Status
44	August 19, 2015	Contacts/Locations and Study Status
45	September 3, 2015	Study Status
46	September 16, 2015	Study Status
47	October 5, 2015	Study Status
48	October 15, 2015	Study Status
49	November 4, 2015	Study Status
50	November 17, 2015	Study Status
51	February 4, 2016	Study Status
52	February 10, 2016	Study Status
53	February 25, 2016	Study Status
54	March 11, 2016	Study Status
55	March 28, 2016	Study Status
56	April 12, 2016	Study Status
57	April 25, 2016	Study Status
58	May 10, 2016	Study Status
59	May 25, 2016	Study Status
60	June 9, 2016	Study Status
61	June 24, 2016	Contacts/Locations and Study Status
62	July 11, 2016	Study Status
63	July 26, 2016	Study Status
64	August 11, 2016	Study Status
65	August 23, 2016	Study Status
66	September 7, 2016	Study Status
67	September 23, 2016	Study Status
68	October 7, 2016	Study Status
69	October 26, 2016	Study Status
70	November 8, 2016	Study Status
71	November 30, 2016	Study Status
72	December 6, 2016	Study Status
73	December 23, 2016	Study Status
74	January 5, 2017	Study Status
75	January 23, 2017	Contacts/Locations and Study Status
76	January 27, 2017	Study Status
77	February 16, 2017	Study Status
78	March 3, 2017	Study Status
79	March 9, 2017	Study Design, Study Status, References and Oversight
80	March 29, 2017	Study Design, References and Study Status
81	April 17, 2017	Study Status
82	August 28, 2017	Study Status, Outcome Measures, Contacts/Locations, References, Study Design and Results
83	October 5, 2017	Study Status and Contacts/Locations
84	March 13, 2018	Contacts/Locations, Study Status and Arms and Interventions
85	August 21, 2019	Contacts/Locations, Study Status, Outcome Measures and References
86	October 21, 2019	Contacts/Locations and Study Status
87	June 17, 2020	Contacts/Locations and Study Status
88	November 19, 2021	Contacts/Locations, Study Status and References
89	April 7, 2022	Contacts/Locations, Oversight and Study Status
90	June 21, 2022	Contacts/Locations and Study Status
91	October 7, 2022	Contacts/Locations and Study Status
92	June 28, 2023	Study Status and Contacts/Locations
93	September 11, 2023	Study Status and Contacts/Locations
94	October 12, 2023	Contacts/Locations, References and Study Status
95	October 24, 2023	Study Status
96	January 5, 2024	References, Study Status and Contacts/Locations

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Study NCT01844505
Submitted Date: April 30, 2013 (v1)

Study Identification


Unique Protocol ID:	CA209-067
Brief Title:	Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate-067)
Official Title:	A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Secondary IDs:	2012-005371-13 [EudraCT Number]

Study Status


Record Verification:	April 2013
Overall Status:	Not yet recruiting
Study Start:	June 2013
Primary Completion:	October 2016 [Anticipated]
Study Completion:	January 2017 [Anticipated]

First Submitted:	April 29, 2013
First Submitted that Met QC Criteria:	April 30, 2013
First Posted:	May 1, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	April 30, 2013
Last Update Posted:	May 1, 2013 [Estimate]

Study Description


Brief Summary:	The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend survival compared to Ipilimumab alone
Detailed Description:	CheckMate 067: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 067

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	915 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Biological: Nivolumab Other Names: BMS-936558 MDX-1106 Biological: Placebo for NivolumabBiological: Placebo for Ipilimumab
Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Biological: Nivolumab Other Names: BMS-936558 MDX-1106 Biological: Ipilimumab Other Names: Yervoy BMS-734016 MDX-010 Biological: Placebo for Nivolumab
Experimental: Arm C: Ipilimumab+Placebo for Nivolumab Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Biological: Ipilimumab Other Names: Yervoy BMS-734016 MDX-010 Biological: Placebo for Nivolumab

Outcome Measures


Primary Outcome Measures:
1.	Endpoint of Overall Survival (OS) in all randomized subjects [ Time Frame: Approximately up to 44.1 months ] OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication
Secondary Outcome Measures:
1.	Progression Free Survival (PFS) [ Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first
2.	Objective Response Rate (ORR) [ Time Frame: Baseline (Day 1), Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) ] ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of randomized subjects for each treatment group. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first
3.	Differences in OS, PFS, and ORR between the two experimental arms [ Time Frame: OS: Approximately up to 44.1 months; PFS and OOR: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ]
4.	OS based on PD-L1 expression [ Time Frame: Baseline (Day 1) ]
5.	Mean changes from baseline in EORTC-QLQ-C30 [ Time Frame: Day 1 of Week 1, Day 1 of Week 5 and Follow up visits 1 and 2 ] European Organisation for Research and Treatment of Care Quality of Life Questionnaire (EORTC QLQ) C-30 global health status/QoL composite scale data and the remaining EORTC QLQ C-30 scale data will be summarized by timepoint using descriptive statistics for each treatment group

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: Histologically confirmed stage III (unresectable) or stage IV melanoma Treatment naïve patients Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: Active brain metastases or leptomeningeal metastases Ocular melanoma Subjects with active, known or suspected autoimmune disease Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

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