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CheckMate 7FL: Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04109066
Collaborator
(none)
506
Enrollment
256
Locations
2
Arms
151
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery)chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
506 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Actual Study Start Date :
Nov 20, 2019
Anticipated Primary Completion Date :
Jun 20, 2032
Anticipated Study Completion Date :
Jun 20, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice

Biological: nivolumab
Specified Dose on Specified days

Drug: paclitaxel (PTX)
Specified dose on Specified days

Drug: anthracycline
Specified dose on Specified days

Drug: cyclophosphamide
Specified dose on Specified days

Drug: Endocrine Therapy
Variable endocrine therapy of investigators choice

Procedure: Surgery
Surgery for breast cancer
Placebo Comparator: Arm B: Placebo combined with neoadjuvant CT and adjuvant ET

Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab placebo with adjuvant (post-surgery) endocrine therapy of investigator's choice

Drug: paclitaxel (PTX)
Specified dose on Specified days

Other: nivolumab placebo
Specified dose on Specified days

Drug: anthracycline
Specified dose on Specified days

Drug: cyclophosphamide
Specified dose on Specified days

Drug: Endocrine Therapy
Variable endocrine therapy of investigators choice

Procedure: Surgery
Surgery for breast cancer

Outcome Measures

Primary Outcome Measures

  1. Pathological Complete response (pCR) Using the definition of ypT0/is ypN0 [approximately 7 months]

  2. Event-Free Survival (EFS) [up to 10 years]

Secondary Outcome Measures

  1. Overall Survival (OS) [up to 10 years]

  2. Disease-free Survival (DFS) [up to 10 years]

  3. Distant Metastasis-free survival (DMFS) [up to 10 years]

  4. pCR using the definition of ypT0 ypN0 [approximately 7 months]

  5. pCR rate using the definition of ypT0/is [approximately 7 months]

  6. Objective response rate (ORR) using definition of tumor response rate per radiologic-based assessment [approximately 7 months]

  7. ORR using definition of tumor response rate per clinic-based physical assessment [approximately 7 months]

  8. Residual cancer burden (RCB) category status (0, I, II, III) [approximately 7 months]

  9. Incidence of adverse events (AEs) [approximately 17 months]

  10. Severity of AEs [approximately 17 months]

  11. Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30) [up to 52 weeks]

  12. Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5) [up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.

  • Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample tested locally and confirmed by the central laboratory, as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines. Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.

  • Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%

  • Must agree to provide primary breast tumor tissue at baseline and at surgery

  • Must be deemed eligible for surgery

  • Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial

  • Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1

Exclusion Criteria:

  • Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment

  • Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment

  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

  • Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association

  • History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time

  • Definitive clinical or radiologic evidence of metastatic disease

  • Multicentric BC (the presence of > 1 tumor in different quadrants of the breast)

  • Bilateral invasive BC

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Local Institution - 0136 Mobile Alabama United States 36604
2 Local Institution - 0052 Greenbrae California United States 94904
3 Local Institution - 0051 Whittier California United States 90603
4 Local Institution - 0182 Stamford Connecticut United States 06904
5 Local Institution - 0150 Jacksonville Florida United States 32256
6 Local Institution - 0097 Miami Florida United States 33136
7 Local Institution - 0149 Pensacola Florida United States 32504
8 Local Institution - 0120 Tallahassee Florida United States 32308
9 Local Institution - 0054 Athens Georgia United States 30607
10 Local Institution - 0107 Atlanta Georgia United States 30342
11 Local Institution - 0056 Columbus Georgia United States 31904
12 Local Institution - 0221 Chicago Illinois United States 60611
13 Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana United States 46804
14 Local Institution Louisville Kentucky United States 40202
15 New England Cancer Specialists Topsham Maine United States 04086
16 American Oncology Partners of Maryland, PA Bethesda Maryland United States 20817
17 HCA Midwest Division Kansas City Missouri United States 64132
18 Local Institution - 0109 Florham Park New Jersey United States 07932
19 Local Institution - 0050 Hackensack New Jersey United States 07601
20 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
21 Local Institution - 0181 Albuquerque New Mexico United States 87131
22 Local Institution - 0041 Bronx New York United States 10461
23 Local Institution - 0283 Charlotte North Carolina United States 28204
24 Duke Cancer Institute Durham North Carolina United States 27710
25 Local Institution Winston-Salem North Carolina United States 27103
26 Local Institution - 0053 Cleveland Ohio United States 44109
27 Local Institution - 0218 Chattanooga Tennessee United States 37404
28 Local Institution - 0121 Fort Worth Texas United States 76104
29 Local Institution - 0224 Fairfax Virginia United States 22031
30 Local Institution - 0122 Fredericksburg Virginia United States 22408
31 Virginia Cancer Institute Richmond Virginia United States 23230
32 Local Institution - 0274 Seattle Washington United States 98109
33 Local Institution - 0020 Caba Buenos Aires Argentina 1417
34 Local Institution Ciudad Autonoma Beunos Aires Buenos Aires Argentina 1431
35 Local Institution - 0015 La Plata Buenos Aires Argentina 1900
36 Local Institution - 0303 Río Cuarto Cordoba Argentina 5800
37 Local Institution Buenos Aires Distrito Federal Argentina C1199
38 Local Institution - 0008 Capital Federal Distrito Federal Argentina C1280AEB
39 Local Institution - 0013 Ciudad Autonoma de Buenos Aires Distrito Federal Argentina 0
40 Local Institution Rosario Santa FE Argentina 2000
41 Clinica Adventista Belgrano Buenos Aires Argentina 1430
42 Local Institution - 0021 Cordoba Argentina 5000
43 Local Institution Cordoba Argentina 5004
44 Local Institution La Rioja Argentina
45 Local Institution Viedma Argentina
46 Local Institution Darlinghurst New South Wales Australia 2010
47 Local Institution - 0071 North Sydney New South Wales Australia 2060
48 Port Macquarie Base Hospital Port Macquarie New South Wales Australia 2444
49 Local Institution Sydney New South Wales Australia 2145
50 Royal Brisbane and Womens Hospital Herston Queensland Australia 4029
51 Calvary Central Districts Hospital Elizabeth Vale South Australia Australia 5112
52 Monash Medical Centre Clayton Clayton Victoria Australia 3168
53 Local Institution Franskton Victoria Australia 3199
54 Austin Hospital Heidelberg Victoria Australia 3084
55 Local Institution - 0070 Melbourne Victoria Australia 3000
56 Local Institution - 0068 North Ballarat Victoria Australia 33500
57 Local Institution Perth Western Australia Australia 6008
58 Local Institution - 0045 Graz Austria 8036
59 Local Institution - 0042 Innsbruck Austria 6020
60 Local Institution - 0048 Salzburg Austria 5020
61 Local Institution - 0046 Wien Austria 1090
62 Local Institution - 0047 Wien Austria 1090
63 Local Institution - 0187 Brussels Belgium 1090
64 Local Institution - 0030 Charleroi Belgium 6000
65 Local Institution - 0037 Edegem Belgium 2650
66 Local Institution - 0032 Gent Belgium 9000
67 Local Institution - 0031 Liege Belgium 4000
68 Local Institution - 0130 Fortaleza Ceara Brazil 60135-237
69 Local Institution - 0225 Brasilia Distrito Federal Brazil 70200-730
70 Local Institution - 0287 Goiânia Goias Brazil 74605070
71 Local Institution - 0133 Belo Horizonte Minas Gerais Brazil 30130-100
72 Local Institution - 0132 Ijui RIO Grande DO SUL Brazil 98700-000
73 Local Institution - 0288 Porto Alegre RIO Grande DO SUL Brazil 90035-001
74 Local Institution - 0131 Porto Alegre Rio Grande Do Sul Brazil 90050-170
75 Local Institution - 0135 Porto Alegre RIO Grande DO SUL Brazil 90610-000
76 Local Institution - 0273 Santa Cruz do Sul RIO Grande DO SUL Brazil 96830-180
77 Local Institution - 0134 Barretos SAO Paulo Brazil 14784-400
78 Local Institution - 0128 Santo Andre SAO Paulo Brazil 09080-000
79 Local Institution - 0272 São Paulo SAO Paulo Brazil 01229-010
80 Local Institution - 0129 Rio de Janeiro Brazil 22793-080
81 Local Institution - 0144 São Paulo Brazil 01317-001
82 Local Institution - 0104 São Paulo Brazil 04378-500
83 Local Institution Halifax Nova Scotia Canada B3H 2Y9
84 Local Institution Oshawa Ontario Canada L1G 2B9
85 Local Institution Ottawa Ontario Canada K1H 8L6
86 Local Institution Thunder Bay Ontario Canada P7B 6V4
87 Local Institution Toronto Ontario Canada M3M 0B2
88 Local Institution Toronto Ontario Canada M5G 2M9
89 Local Institution Montreal Quebec Canada H3T 1E2
90 Centre Hospitalier de l'Université de Montréal-Breast Cancer Montréal Quebec Canada H2X 0C1
91 Local Institution - 0058 Sherbrooke Quebec Canada J1H 5N4
92 Local Institution - 0197 La Serena Coquimbo Chile 1720430
93 Local Institution - 0016 Santiago de Chile Metropolitana Chile 0
94 Local Institution - 0019 Santiago Region Metropolitana Metropolitana Chile 8330034
95 Local Institution - 0318 Santiago Metropolitana Chile 6900941
96 Local Institution - 0018 Vina del Mar Valparaiso Chile 2520598
97 Local Institution - 0326 Antofagasta Chile
98 Local Institution - 0235 Bengbu Anhui China 233004
99 Local Institution - 0239 Hefei Anhui China 230031
100 Local Institution Beijing Beijing China 100021
101 Local Institution - 0215 Beijing Beijing China 100044
102 Local Institution - 0319 Chongqing Chongqing China 400016
103 Local Institution - 0232 Chongqing Chongqing China 400030
104 Local Institution - 0267 Guangzhou Guangdong China 510060
105 Local Institution - 0241 Guangzhou Guangdong China 510080
106 Local Institution Guangzhou Guangdong China 510515
107 Local Institution - 0312 Zunyi Guizhou China 563000
108 Local Institution - 0240 Shjiazhuang Hebei China 50051
109 Local Institution - 0250 Wuhan Hebei China 430022
110 Local Institution - 0248 Harbin Heilongjiang China 150001
111 Local Institution Zhengzhou Henan China
112 Local Institution - 0255 Changchun Jilin China 130012
113 Local Institution - 0247 Changchun Jilin China 130021
114 Local Institution Shenyang Liaoning China 110001
115 Local Institution - 0252 Shenyang Liaoning China 110042
116 Local Institution - 0263 Xian Shan3xi China 710061
117 Local Institution - 0245 Jinan Shandong China 250117
118 Local Institution - 0256 Qingdao Shandong China 266000
119 Local Institution - 0214 YanTai Shandong China 264000
120 Local Institution - 0127 Shanghai Shanghai China 200032
121 Local Institution - 0244 Chengdu Sichuan China 610041
122 Local Institution - 0254 Tianjin Tianjin China 300060
123 Local Institution - 0311 Urumqi Xinjiang China 830000
124 Local Institution - 0238 Hangzhou Zhejiang China 310000
125 Local Institution - 0231 Hangzhou Zhejiang China 310003
126 Local Institution - 0237 Hangzhou Zhejiang China 310009
127 Local Institution Xiamen China
128 Local Institution Colombia Bogota Colombia
129 Local Institution - 0094 Bogotá Distrito Capital De Bogotá Colombia 110221
130 Local Institution - 0098 Piedecuesta Santander Colombia 681017
131 Local Institution - 0261 Barranquilla Colombia 080020
132 Local Institution - 0093 Cali Colombia 0
133 Local Institution - 0113 Monteria Colombia 230001
134 Local Institution Pereira Colombia
135 Local Institution Rionegro, Antioquia Colombia
136 Klinika onkologie a radioterapie Hradec Kralove Czechia 500 05
137 Komplexni onkologicke centrum Novy Jicin Czechia 741 01
138 Onkologicka klinika Olomouc Czechia 77900
139 Local Institution - 0099 Praha 10 Czechia 100 34
140 Local Institution - 0167 Aarhus N Denmark 8200
141 Local Institution - 0165 Herlev Denmark 2730
142 Local Institution - 0164 Kobenhavn O Denmark 2100
143 Local Institution - 0166 Naestved Denmark 4700
144 Local Institution - 0001 Helsinki Finland 00029
145 Local Institution - 0160 Tampere Finland 33521
146 Local Institution - 0004 Besancon France 25030
147 Local Institution - 0024 Brest France 29200
148 Centre Jean Perrin Clermont-ferrand France 63000
149 Clinique Victor Hugo Le Mans France 72000
150 Hopital Prive Jean Mermoz Lyon France 69000
151 Local Institution - 0152 Montpellier France 34298
152 Hopital Europeen Georges Pompidou Paris France 75015
153 Local Institution - 0195 Plerin France 22190
154 Institut De Cancerologie De L Ouest Saint Herblain Cedex France 44805
155 Clinique Sainte Anne Strasbourg France 67085
156 Centre Hospitalier intercommunal de Toulon La Seyne sur Mer Toulon France 83100
157 Local Institution - 0003 Villejuif France 94800
158 Local Institution - 0084 München Bayern Germany 80337
159 Local Institution - 0083 Berlin Germany 13125
160 Local Institution - 0112 Dresden Germany 01307
161 Local Institution - 0081 Essen Germany 45147
162 Local Institution - 0158 Frankfurt Germany 60590
163 Local Institution - 0223 Hamburg Germany 20259
164 Local Institution - 0087 Heidelberg Germany 69126
165 Local Institution - 0089 Homburg Germany 66421
166 Local Institution - 0080 Köln Germany 50937
167 Local Institution - 0196 Leipzig Germany 04103
168 Local Institution - 0111 Moenchengladbach Germany 41061
169 Local Institution - 0156 Rostock Germany 18059
170 Local Institution - 0079 Saarbruecken Germany 66112
171 Local Institution - 0157 Velbert Germany 42551
172 Local Institution - 0105 Würzburg Germany 97080
173 Local Institution - 0115 Hong Kong Hong Kong 0
174 Local Institution - 0034 Dublin 8 Dublin Ireland
175 Cork University Hospital Cork Ireland
176 Local Institution Dublin Ireland 9
177 Local Institution Catania Italy 95122
178 Azienda Ospedaliero-Universitaria Mater Domini Catanzaro Italy 88100
179 Local Institution - 0207 Milano Italy 20141
180 Local Institution - 0124 Napoli Italy 80131
181 Local Institution - 0183 Napoli Italy 80131
182 Local Institution - 0155 Padova Italy 35128
183 Local Institution - 0126 Pavia Italy 27100
184 Local Institution Roma Italy 00128
185 Local Institution - 0125 Rozzano (MI) Italy 20089
186 Local Institution - 0325 Seongnam Korea, Republic of 13620
187 Local Institution - 0295 Seoul Korea, Republic of 03080
188 Local Institution - 0320 Seoul Korea, Republic of 03722
189 Local Institution - 0290 Seoul Korea, Republic of 05505
190 Local Institution - 0291 Seoul Korea, Republic of 06351
191 Local Institution - 0262 Tijuana BAJA California Mexico 22010
192 Local Institution - 0168 Mexico City Distrito Federal Mexico 03100
193 Local Institution - 0154 Mexico City Distrito Federal Mexico 14080
194 Local Institution Zapopan Jalisco Mexico 45070
195 Local Institution - 0137 Monterrey Nuevo LEON Mexico 64320
196 Local Institution - 0212 Merida Yucatán Mexico 97125
197 Local Institution Campeche Mexico 24050
198 Local Institution - 0091 Chihuahua Mexico 31000
199 Local Institution Colima Mexico 28018
200 Local Institution - 0141 Oaxaca Mexico 68020
201 Antoni Van Leeuwenhoek Ziekenhuis Amsterdam Netherlands 1066 CX
202 Local Institution - 0177 Breda Netherlands 4818CK
203 Local Institution - 0199 Deventer Netherlands 7416 SE
204 Local Institution Rotterdam Netherlands 3000 CA
205 Local Institution Utrecht Netherlands 3584 CX
206 Local Institution - 0335 Bydgoszcz Poland 85796
207 Local Institution - 0334 Gliwice Poland 44-101
208 Oddzial Dzienny Chemioterapii Koszalin Poland 75-581
209 Local Institution Krakow Poland 31-531
210 Klinika Onkologii CZMP Lodz Poland 93-338
211 Local Institution Opole Poland 45-061
212 Local Institution - 0060 Warszawa Poland 02-781
213 Local Institution - 0210 Lisboa Portugal 1500-650
214 Local Institution - 0211 Lisboa Portugal 1649-035
215 Local Institution - 0209 Porto Portugal 4200
216 Local Institution - 0110 Ponce Puerto Rico 00716-0200
217 Local Institution - 0029 Bucharest Romania 011171
218 Local Institution Bucharest Romania 022328
219 Local Institution - 0025 Bucuresti Romania 022328
220 Local Institution Craiova Romania 200347
221 Local Institution - 0027 Floresti Romania 407280
222 Local Institution Suceava Romania 720237
223 Local Institution Krasnodar Russian Federation 350040
224 Local Institution Moscow Russian Federation 115478
225 Local Institution Moscow Russian Federation 125367
226 Local Institution - 0285 Moskva Russian Federation 111123
227 Local Institution Ryazan Russian Federation 390011
228 Local Institution - 0284 Saint Petersburg Russian Federation 197758
229 Local Institution - 0306 Sankt-Peterburg Russian Federation 194107
230 Local Institution Sochi Russian Federation 354057
231 Local Institution - 0078 Singapore Singapore 119228
232 Local Institution - 0076 Singapore Singapore 169610
233 Local Institution - 0077 Singapore Singapore 308442
234 Local Institution - 0171 Barcelona Spain 08035
235 Local Institution - 0172 Barcelona Spain 08036
236 Local Institution - 0205 Elche (Alicante) Spain 03203
237 Local Institution - 0173 Madrid Spain 28040
238 Local Institution - 0176 Madrid Spain 28050
239 Local Institution - 0169 Malaga Spain 29010
240 Local Institution - 0204 Pamplona Spain 31008
241 Local Institution - 0174 Santiago de Compostela Spain 15706
242 Local Institution - 0170 Sevilla Spain 41013
243 Local Institution - 0184 Basel Switzerland 4031
244 CHUV Lausanne Switzerland 1011
245 Local Institution - 0185 Thun Switzerland 3600
246 Local Institution - 0301 Kaohsiung Taiwan 807
247 Local Institution - 0300 Tainan City Taiwan 71004
248 Local Institution - 0298 Tainan Taiwan 70457
249 Local Institution - 0305 Taipei Taiwan 10449
250 Local Institution - 0297 Taipei Taiwan 112
251 Local Institution - 0073 Adana Turkey 01060
252 Local Institution Ankara Turkey 06520
253 Local Institution Antalya Turkey 07070
254 Local Institution Istanbul Turkey 34300
255 Local Institution - 0006 Withington Manchester United Kingdom M20 4BX
256 Local Institution - 0005 London United Kingdom NW1 2BU

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04109066
Other Study ID Numbers:
  • CA209-7FL
First Posted:
Sep 30, 2019
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb
Nivolumab
Breast Cancer
Cancer
Estrogen Receptor-Positive (ER+)
Human Epidermal Growth Factor 2 Negative (HER2-)
Neoadjuvant
Adjuvant
Primary Breast Cancer
Additional relevant MeSH terms:
Breast Neoplasms
Paclitaxel
Cyclophosphamide
Nivolumab

Study Results

No Results Posted as of Jul 22, 2022