Actively Recruiting
A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
150
Participants Needed
59
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating calderasib, alone or combined with cetuximab, to treat advanced solid tumors in people with the KRAS G12C mutation. This phase 2, open-label study aims to learn how many patients respond to these treatments and to assess their safety and tolerability. The study is tumor-agnostic, meaning it includes various solid tumors except colorectal cancer, focusing on those that have progressed after standard treatments. Participants will be randomly assigned to receive either calderasib alone or calderasib combined with cetuximab. Calderasib is taken orally, and cetuximab is given by intravenous infusion every two weeks. There is no maximum number of treatment cycles, and participants continue treatment until they meet specific criteria for stopping. During the study, participants will be closely monitored for tumor response, adverse events, and treatment discontinuation due to side effects over up to approximately 76 months. Researchers will measure outcomes such as objective response rate, progression-free survival, duration of response, overall survival, and safety. The study begins with screening and continues with regular treatment visits and follow-ups to collect these data.
CONDITIONS
Brief Title
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has locally advanced unresectable or metastatic solid tumor other than colorectal cancer that has progressed after standard systemic treatment
- Tumor demonstrates presence of KRAS G12C mutation
- Age 18 years or older
You will not qualify if you...
- Has uncontrolled, significant cardiovascular or cerebrovascular disease
- Has additional malignancy that is progressing or required active treatment within past 3 years
- Has active central nervous system metastases, carcinomatous meningitis, or primary brain tumors
- Has active infection requiring systemic therapy (other than permitted infections)
- Has not recovered adequately from major surgery or has ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated cycles with no maximum number until discontinuation
Participants receive oral Calderasib alone or in combination with intravenous Cetuximab every 2 weeks. Treatment continues until discontinuation criteria are met.
Cetuximab administered every 2 weeks; oral Calderasib taken continuously
Trial Site Locations
Total: 59 locations
1
Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, United States, 21204
Actively Recruiting
2
START Midwest ( Site 1103)
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Comprehensive Cancer Centers of Nevada ( Site 1109)
Las Vegas, Nevada, United States, 89169
Actively Recruiting
4
Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
5
START Mountain Region ( Site 1106)
West Valley City, Utah, United States, 84119
Actively Recruiting
6
Virginia Cancer Specialists ( Site 1102)
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Prince of Wales Hospital-Medical Oncology ( Site 1003)
Randwick, New South Wales, Australia, 2031
Actively Recruiting
8
Westmead Hospital ( Site 1000)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
9
Epworth Freemasons ( Site 1004)
Melbourne, Victoria, Australia, 3002
Actively Recruiting
10
Jewish General Hospital-CRU ( Site 2900)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
11
FALP ( Site 1200)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
12
Centro de Oncología de Precisión ( Site 1202)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
13
Clinica San Carlos de Apoquindo ( Site 1203)
Santiago, Region M. de Santiago, Chile, 7620002
Actively Recruiting
14
Bradfordhill ( Site 1201)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
15
Beijing Cancer hospital ( Site 1318)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
16
The First Affiliated Hospital of Xiamen University ( Site 1304)
Xiamen, Fujian, China, 361003
Actively Recruiting
17
Sun Yat-sen University Cancer Center ( Site 1303)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
18
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)
Wuhan, Hubei, China, 430000
Actively Recruiting
19
Jiangsu Province Hospital ( Site 1324)
Nanjing, Jiangsu, China, 210029
Actively Recruiting
20
Jinan Central Hospital ( Site 1313)
Jinan, Shandong, China, 250013
Actively Recruiting
21
Shanghai Chest Hospital ( Site 1300)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
22
Fudan University Shanghai Cancer Center ( Site 1325)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
23
Zhongshan Hospital,Fudan University ( Site 1301)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
24
Zhejiang Cancer Hospital ( Site 1311)
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
25
Taizhou Hospital of Zhejiang Province ( Site 1312)
Linhai, Zhejiang, China, 317000
Actively Recruiting
26
Rigshospitalet ( Site 1403)
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
27
Odense Universitetshospital ( Site 1401)
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
28
Universitätsklinikum Leipzig ( Site 1602)
Leipzig, Saxony, Germany, 04103
Actively Recruiting
29
Universitätsklinikum Jena ( Site 1603)
Jena, Thuringia, Germany, 07747
Actively Recruiting
30
General Hospital of Athens "Laiko" ( Site 1701)
Athens, Attica, Greece, 11527
Actively Recruiting
31
European Interbalkan Medical Center-Oncology Department ( Site 1700)
Thessaloniki, Greece, 57001
Actively Recruiting
32
Emek Medical Center ( Site 1800)
Afula, Israel, 1834111
Actively Recruiting
33
Hadassah Medical Center ( Site 1801)
Jerusalem, Israel, 9112001
Actively Recruiting
34
Sourasky Medical Center ( Site 1802)
Tel Aviv, Israel, 6423906
Actively Recruiting
35
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)
Rozzano, Milano, Italy, 20089
Actively Recruiting
36
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900)
Milan, Italy, 20133
Actively Recruiting
37
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901)
Roma, Italy, 00168
Actively Recruiting
38
National Cancer Center Hospital ( Site 2000)
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
39
Cancer Institute Hospital of JFCR ( Site 2003)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
40
Haukeland universitetssykehus ( Site 2102)
Bergen, Hordaland, Norway, 5021
Actively Recruiting
41
Oslo universitetssykehus, Radiumhospitalet ( Site 2101)
Oslo, Norway, 0379
Actively Recruiting
42
MTZ Clinical Research powered by Pratia ( Site 2205)
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
43
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
44
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
45
Seoul National University Hospital ( Site 2301)
Seoul, South Korea, 03080
Actively Recruiting
46
Asan Medical Center ( Site 2302)
Seoul, South Korea, 05505
Actively Recruiting
47
Samsung Medical Center ( Site 2300)
Seoul, South Korea, 06351
Actively Recruiting
48
Hospital Virgen de la Victoria ( Site 2403)
Málaga, Malaga, Spain, 29010
Actively Recruiting
49
Hospital Universitari Vall d Hebron ( Site 2401)
Barcelona, Spain, 08035
Actively Recruiting
50
Hospital Clinic de Barcelona ( Site 2402)
Barcelona, Spain, 08036
Actively Recruiting
51
Hospital Clinico San Carlos ( Site 2404)
Madrid, Spain, 28040
Actively Recruiting
52
Karolinska Universitetssjukhuset Solna ( Site 2501)
Stockholm, Stockholm County, Sweden, 171 64
Actively Recruiting
53
Sahlgrenska Universitetssjukhuset. ( Site 2502)
Gothenburg, Västra Götaland County, Sweden, 413 45
Actively Recruiting
54
Adana Medical Park Seyhan Hastanesi ( Site 2706)
Adana, Turkey (Türkiye), 01140
Actively Recruiting
55
Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
56
Hacettepe Universitesi-oncology hospital ( Site 2700)
Ankara, Turkey (Türkiye), 6230
Actively Recruiting
57
Koc University Hospital ( Site 2704)
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
58
Royal Free Hospital ( Site 2801)
London, Camden, United Kingdom, NW3 2QG
Actively Recruiting
59
The Christie NHS Foundation Trust ( Site 2803)
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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