A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors

This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: Pembrolizumab; Drug: MK-1084; Drug: carboplatin; Drug: pemetrexed; Biological: cetuximab; Drug: oxaliplatin; Drug: leucovorin; Drug: 5-fluorouracil

• Study Type: Interventional
• Enrollment (Estimated): 830
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@merck.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse ( Site 0002)
      • Contact: Study Coordinator; Phone Number: 61285140162
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital-Medical Oncology ( Site 0001)
      • Contact: Study Coordinator; Phone Number: 61287389744
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital-Department of Medical Oncology ( Site 0006)
      • Contact: Study Coordinator; Phone Number: 61403170371
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health-Oncology Research ( Site 0003)
      • Contact: Study Coordinator; Phone Number: 6385722429
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Recruiting
      • The Moncton Hospital ( Site 0037)
      • Contact: Study Coordinator; Phone Number: 506-857-5104
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
      • Contact: Study Coordinator; Phone Number: 905-387-9495
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
      • Contact: Study Coordinator; Phone Number: 613-549-6666x4502
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
      • Contact: Study Coordinator; Phone Number: 416-946-4501
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • Completed
      • James Lind Centro de Investigación del Cáncer ( Site 0043)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 7500653
      • Recruiting
      • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
      • Contact: Study Coordinator; Phone Number: +56 9 9161 2199
    • Santiago, Region M. De Santiago, Chile, 8420383
      • Recruiting
      • Bradfordhill ( Site 0042)
      • Contact: Study Coordinator; Phone Number: +56998744662
    • Santiago, Region M. De Santiago, Chile, 7500921
      • Recruiting
      • FALP-UIDO ( Site 0040)
      • Contact: Study Coordinator; Phone Number: +56981369487
• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
      • Contact: Study Coordinator; Phone Number: 8613021161027
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital ( Site 0419)
      • Contact: Study Coordinator; Phone Number: 8613509339525
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
      • Contact: Study Coordinator; Phone Number: 8620 62787110
    • Guangzhou, Guangdong, China, 511400
      • Recruiting
      • Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
      • Contact: Study Coordinator; Phone Number: 86 13922206676
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0418)
      • Contact: Study Coordinator; Phone Number: 13808640033
  • Jilin
    • Changchun, Jilin, China, 132000
      • Recruiting
      • Jilin Cancer Hospital-oncology department ( Site 0412)
      • Contact: Study Coordinator; Phone Number: 8613943012851
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital-Oncology department ( Site 0410)
      • Contact: Study Coordinator; Phone Number: 021-22200000
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital ( Site 0416)
      • Contact: Study Coordinator; Phone Number: 8617721230109
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
      • Contact: Study Coordinator; Phone Number: 13858182310
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus-Oncology ( Site 0090)
    • Contact: Study Coordinator; Phone Number: +97247776717
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center-Oncology ( Site 0092)
    • Contact: Study Coordinator; Phone Number: +972587040620
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Medical Center-Oncology ( Site 0094)
    • Contact: Study Coordinator; Phone Number: 972505172537
  • Kfar Saba, Israel, 4428164
    • Recruiting
    • Meir Medical Center ( Site 0091)
    • Contact: Study Coordinator; Phone Number: 97297472414
  • Ramat Gan, Israel, 5265601
    • Recruiting
    • Sheba Medical Center-ONCOLOGY ( Site 0093)
    • Contact: Study Coordinator; Phone Number: 97235307096
• Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East ( Site 0404)
      • Contact: Study Coordinator; Phone Number: +81-4-7133-1111
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa cancer center ( Site 0402)
      • Contact: Study Coordinator; Phone Number: +81-45-520-2222
  • Shizuoka
    • Nagaizumi, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center ( Site 0401)
      • Contact: Study Coordinator; Phone Number: +81-55-989-5222
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital ( Site 0403)
      • Contact: Study Coordinator; Phone Number: +81-3-3542-2511
    • Koto, Tokyo, Japan, 135-8550
      • Recruiting
      • Japanese Foundation for Cancer Research ( Site 0400)
      • Contact: Study Coordinator; Phone Number: +81-3-3520-0111
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital ( Site 0191)
    • Contact: Study Coordinator; Phone Number: 82220722995
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)
    • Contact: Study Coordinator; Phone Number: 82234103459
• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Completed
      • New Zealand Clinical Research (Christchurch) ( Site 0004)
• Panama
  • Panama City, Panama, 082410
    • Recruiting
    • Centro Oncologico de Panama ( Site 0160)
    • Contact: Study Coordinator; Phone Number: +50764807461
  • Panama City, Panama, 0832-00752
    • Recruiting
    • Centro Hemato Oncológico Paitilla ( Site 0163)
    • Contact: Study Coordinator; Phone Number: +50766150221
• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Recruiting
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170
      • Contact: Study Coordinator; Phone Number: 48225463381
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-952
      • Recruiting
      • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
      • Contact: Study Coordinator; Phone Number: 48585844571
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-780
      • Recruiting
      • Szpital Kliniczny im. H. Swiecickiego nr 2-Medical and Experimental Oncology ( Site 0172)
      • Contact: Study Coordinator; Phone Number: 48606228277
  • Zachodniopomorskie
    • Koszalin, Zachodniopomorskie, Poland, 75-581
      • Recruiting
      • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0173)
      • Contact: Study Coordinator; Phone Number: 48502204953
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)
    • Contact: Study Coordinator; Phone Number: +34 93 274 60 00; ext. 6988
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28027
      • Recruiting
      • Clinica Universidad de Navarra ( Site 0213)
      • Contact: Study Coordinator; Phone Number: +34913531920 ext 7501
    • Madrid, Madrid, Comunidad De, Spain, 28040
      • Recruiting
      • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)
      • Contact: Study Coordinator; Phone Number: 0034 91 550 48 00 ext 2689
• Switzerland
  • Sankt Gallen
    • St.Gallen, Sankt Gallen, Switzerland, 9007
      • Recruiting
      • Cantonal Hospital St.Gallen ( Site 0224)
      • Contact: Study Coordinator; Phone Number: 071/494 11 11
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Recruiting
      • Ospedale Regionale Bellinzona e Valli ( Site 0220)
      • Contact: Study Coordinator; Phone Number: 41918118045
• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital ( Site 0444)
    • Contact: Study Coordinator; Phone Number: 886623535354559
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital-Oncology ( Site 0443)
    • Contact: Study Coordinator; Phone Number: 886223123456
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Recruiting
      • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)
      • Contact: Study Coordinator; Phone Number: +886773171233267
• Turkey
  • Ankara, Turkey, 06230
    • Recruiting
    • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)
    • Contact: Study Coordinator; Phone Number: 905334318506
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06200
      • Recruiting
      • Ankara City Hospital-oncology ( Site 0233)
      • Contact: Study Coordinator; Phone Number: 905555306271
  • Izmir
    • Bornova, Izmir, Turkey, 35100
      • Recruiting
      • Ege University Medicine of Faculty ( Site 0231)
      • Contact: Study Coordinator; Phone Number: 905322202675
  • Kayseri
    • Talas, Kayseri, Turkey, 38039
      • Recruiting
      • Erciyes University ( Site 0232)
      • Contact: Study Coordinator; Phone Number: +905053883441
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center ( Site 0261)
      • Contact: Study Coordinator; Phone Number: 813-745-5995
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest ( Site 0267)
      • Contact: Study Coordinator; Phone Number: 616-954-5554
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
      • Contact: Study Coordinator; Phone Number: 551-996-5900
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Laura and Isaac Perlmutter Cancer Center ( Site 0270)
      • Contact: Study Coordinator; Phone Number: 212-731-5755
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia ( Site 0271)
      • Contact: Study Coordinator; Phone Number: 703-280-5390
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
      • Contact: Study Coordinator; Phone Number: 414-805-0505

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For all participants:

• Has measurable disease by RECIST 1.1 criteria
• Has adequate organ function
• Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic
• Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention

For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

For Arm 2

- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%

For Arm 3

• Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
• Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
• Previous treatment failure of 2 or 3 previous lines of systemic therapy Expansion Group B
• Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation

Arm 5 only

• Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
• Previous treatment failure of one or 2 previous line(s) of systemic therapy

Arm 6 only

- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation

Exclusion Criteria:

• Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
• Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
• Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active infection requiring systemic therapy
• Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
• Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
• Has an active autoimmune disease requiring systemic therapy
• Has not fully recovered from any effects of major surgical procedure without significant detectable infection
• Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
• Has received live or live-attenuated vaccine within 4 weeks of study start

Arm 4 Only

• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
• Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Participants will receive daily oral escalating doses of up to 800 mg of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.	Drug: MK-1084; Oral dose
Experimental: Arm 2; Participants will receive MK-1084 daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to ~24 months). Treatment with MK-1084 will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.	Biological: Pembrolizumab; Intravenous infusion of 200 mg; Other Names: MK-3475; KEYTRUDA®; Drug: MK-1084; Oral dose
Experimental: Arm 3; Participants will receive alternate formulation of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.	Drug: MK-1084; Oral dose
Experimental: Arm 4; Participants will receive MK-1084 daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to ~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.	Biological: Pembrolizumab; Intravenous infusion of 200 mg; Other Names: MK-3475; KEYTRUDA®; Drug: MK-1084; Oral dose; Drug: carboplatin; Per label; Drug: pemetrexed; Per label
Experimental: Arm 5; Participants will receive MK-1084 daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.	Drug: MK-1084; Oral dose; Biological: cetuximab; Per label
Experimental: Arm 6; Participants will receive MK-1084 daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.	Drug: MK-1084; Oral dose; Biological: cetuximab; Per label; Drug: oxaliplatin; Per label; Drug: leucovorin; Per label; Drug: 5-fluorouracil; Per label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)	A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT will be reported.	Up to ~21 days
Number of Participants Who Experience an Adverse Event (AE)	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be reported.	Up to ~56 months
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.	Up to ~56 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 will be reported.	Up to ~56 months
Duration of Response (DOR)	DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator will be reported.	Up to ~56 months
Mean Plasma Concentration of MK-1084	Mean Plasma Concentration of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Maximum Concentration (Cmax) of MK-1084	Cmax of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6).
Time to Maximum Concentration (Tmax) of MK-1084	Tmax of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Minimum Concentration (Cmin) of MK-1084	Cmin of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Area Under the Concentration Time-Curve 0-12 Hours (AUC 0-12) of MK-1084	AUC 0-12 of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 12 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Area Under the Concentration Time-Curve 0-24 Hours (AUC 0-24) of MK-1084	AUC 0-24 of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 24 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Half-Life (t1/2) of MK-1084	Half-Life (t1/2) of MK-1084 determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.	At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 24 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Estimated): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Antineoplastic Agents, Immunological; Micronutrients; Vitamins; Immune Checkpoint Inhibitors; Antidotes; Vitamin B Complex; Folic Acid Antagonists; Carboplatin; Fluorouracil; Oxaliplatin; Pembrolizumab; Leucovorin; Pemetrexed; Cetuximab
• Other Study ID Numbers: 1084-001; MK-1084-001 (Other Identifier: Merck); jRCT2041220034 (Registry Identifier: jRCT); 2021-004024-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No