A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06077760
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intismeran autogene — BIOLOGICAL
    IM injection
  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Placebo — OTHER
    IM injection

Study Details

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Key Dates

Start date
Dec 6, 2023
Status verified
May 2026
Primary completion
Jun 25, 2030
Completion
Dec 21, 2035

Study Design

Enrollment
868 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intismeran autogene + Pembrolizumab
    Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
  • Active Comparator: Placebo + Pembrolizumab
    Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Primary Outcome Measure

Disease- Free Survival (DFS) [ Time Frame: Up to ~78 months ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Alaska Oncology and Hematology ( Site 0039)AnchorageAlaska99508
Study Coordinator
907-257-9851
The University of Arizona Cancer Center - North Campus ( Site 0071)TucsonArizona85719
Study Coordinator
520-694-2873
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)YumaArizona85364-
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)Los AngelesCalifornia90095
Study Coordinator
310-267-9099
Hoag Memorial Hospital Presbyterian ( Site 4042)Newport BeachCalifornia92663
Study Coordinator
949-764-4060
Hoag Memorial Hospital Presbyterian ( Site 4048)Newport BeachCalifornia92663
Study Coordinator
949-764-4060
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)OrangeCalifornia92868
Study Coordinator
714-541-6622
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)OrangeCalifornia92868
Study Coordinator
818-426-7690
UCHealth Memorial Hospital-Heme Onc ( Site 0052)Colorado SpringsColorado80909-
George Washington University Medical Faculty Associates ( Site 4064)Washington D.C.District of Columbia20037
Study Coordinator
202-741-2210
Mayo Clinic Florida ( Site 4043)JacksonvilleFlorida32224
Study Coordinator
855-776-0015
Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)MiamiFlorida33176
Study Coordinator
786-596-2000
Mid Florida Hematology and Oncology Center ( Site 0014)Orange CityFlorida32763
Study Coordinator
386-538-3169
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)OrlandoFlorida32804
Study Coordinator
407-303-2024
Moffitt Cancer Center ( Site 0078)TampaFlorida33612
Study Coordinator
813-580-7073
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)MariettaGeorgia30060-
Southeastern Regional Medical Center ( Site 0098)NewnanGeorgia30265
Study Coordinator
770-400-6305
Beacon Cancer Care ( Site 0044)Post FallsIdaho83854-
Illinois Cancer Care ( Site 7003)PeoriaIllinois61615
Study Coordinator
309-243-3605
University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)Iowa CityIowa52242
Study Coordinator
319-356-1616
Saint Elizabeth Healthcare ( Site 0092)EdgewoodKentucky41017
Study Coordinator
859-301-4737
The University of Louisville, James Graham Brown Cancer Center ( Site 0037)LouisvilleKentucky40202
Study Coordinator
502-562-3919
LSU Health Baton Rouge North Clinic ( Site 4040)Baton RougeLouisiana70805
Study Coordinator
225-358-2312
Our Lady of the Lake RMC-Clinical Research ( Site 4050)Baton RougeLouisiana70808
Study Coordinator
225-358-2312
University of Michigan Clinical Trials Office ( Site 0058)Ann ArborMichigan48109
Study Coordinator
800-865-1125
Cancer and Hematology Centers of Western Michigan ( Site 4003)Grand RapidsMichigan49503
Study Coordinator
616-954-9800
St. Vincent Frontier Cancer Center ( Site 0043)BillingsMontana59102-
NHO Revive Research Institute, LLC ( Site 4009)LincolnNebraska68506
Study Coordinator
284-564-1485
Memorial Sloan Kettering - Basking Ridge ( Site 4056)Basking RidgeNew Jersey07920
Study Coordinator
646-888-4409
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)HackensackNew Jersey07601
Study Coordinator
551-996-5855
Memorial Sloan Kettering - Monmouth ( Site 4057)MiddletownNew Jersey07748
Study Coordinator
646-888-4409
Memorial Sloan Kettering - Bergen ( Site 4059)MontvaleNew Jersey07645
Study Coordinator
646-888-4409
Atlantic Health Morristown Medical Center ( Site 4018)MorristownNew Jersey07960
Study Coordinator
973-971-6283
New York Oncology Hematology, P.C. ( Site 4012)AlbanyNew York12206
Study Coordinator
518-489-0044
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)CommackNew York11725
Study Coordinator
646-888-4409
Memorial Sloan Kettering - Westchester ( Site 4058)HarrisonNew York10604
Study Coordinator
646-888-4409
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)MineolaNew York11501
Study Coordinator
409-543-5553
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)New YorkNew York10032-
Icahn School of Medicine at Mount Sinai ( Site 0034)New YorkNew York10029
Study Coordinator
888-577-8839
Laura and Isaac Perlmutter Cancer Center ( Site 0010)New YorkNew York10016
Study Coordinator
409-543-5553
Memorial Sloan Kettering Cancer Center ( Site 0029)New YorkNew York10065
Study Coordinator
212-639-2000
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)New YorkNew York10011
Study Coordinator
888-577-8839
Stony Brook University-Cancer Center ( Site 0072)Stony BrookNew York11794-
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)The BronxNew York10461
Study Coordinator
718-405-8404
Memorial Sloan Kettering - Nassau ( Site 4060)UniondaleNew York11553
Study Coordinator
646-888-4409
Novant Health Weisiger Cancer Insititute ( Site 4052)CharlotteNorth Carolina28204
Study Coordinator
980-302-6000
Novant Health Oncology Specialists ( Site 4045)Winston-SalemNorth Carolina27103
Study Coordinator
336-277-8800
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)FargoNorth Dakota58102
Study Coordinator
701-234-6161
Altru Health System ( Site 0040)Grand ForksNorth Dakota58201
Study Coordinator
701-780-5400
Summa Health ( Site 4011)AkronOhio44304-
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)CincinnatiOhio45220-
University Hospitals Cleveland Medical Center ( Site 0023)ClevelandOhio44106
Study Coordinator
800-641-2422
OSU Brain and Spine Hospital ( Site 0016)ColumbusOhio43210
Study Coordinator
614-366-6174
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)CorvallisOregon97330
Study Coordinator
541-768-7169
Thomas Jefferson University - Clinical Research Institute ( Site 0006)PhiladelphiaPennsylvania19107
Study Coordinator
215-600-9151
Medical University of South Carolina-Hollings Cancer Center ( Site 0050)CharlestonSouth Carolina29425
Study Coordinator
843-792-9300
Sanford Cancer Center ( Site 0075)Sioux FallsSouth Dakota57104-
Greco-Hainsworth Centers for Research ( Site 4034)ChattanoogaTennessee37421
Study Coordinator
423-698-1844
Thompson Cancer Survival Center ( Site 0097)KnoxvilleTennessee37916
Study Coordinator
865-331-1812
Baptist Cancer Center ( Site 4049)MemphisTennessee38120
Study Coordinator
901-226-1485
One Oncology - Tennessee Oncology ( Site 4019)NashvilleTennessee37203
Study Coordinator
731-267-3491
SCRI Oncology Partners ( Site 7001)NashvilleTennessee37203
Study Coordinator
615-329-7640
UT Southwestern Medical Center ( Site 0061)DallasTexas75390
Study Coordinator
214-648-3111
Inova Schar Cancer Institute ( Site 0003)FairfaxVirginia22031
Study Coordinator
571-472-4724
Virginia Cancer Specialists (VCS) ( Site 4004)FairfaxVirginia22031
Study Coordinator
730-280-5390
Fred Hutchinson Cancer Center ( Site 0002)SeattleWashington98109
Study Coordinator
206-606-4801
Swedish Medical Center-Swedish Cancer Institute ( Site 0088)SeattleWashington98104
Study Coordinator
206-386-2323
Edwards Comprehensive Cancer Center ( Site 4015)HuntingtonWest Virginia25701
Study Coordinator
304-399-6521

Find similar trials in Anchorage, AK

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Alaska Oncology and Hematology· Anchorage, AKThe University of Arizona Cancer Center - North Campus· Tucson, AZYUMA REGIONAL MEDICAL CENTER CANCER CENTER· Yuma, AZUCLA Clinical & Translational Research Center (CTRC)· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CASt. Joseph Hospital-The Center for Cancer Prevention and Treatment· Orange, CA

Related Studies