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Gastroesophageal JunctionPhase 1/2NCT06469944

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

A Phase 1/2 study testing Pembrolizumab, Sacituzumab Tirumotecan (sac-TMT) and Capecitabine in people with Gastroesophageal Junction and Gastroesophageal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 50 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Sacituzumab Tirumotecan (sac-TMT) and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
50 sitesin 12 countries
Study dates
20 Sep 2024to 12 Sep 2029
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma
  • Is not expected to require tumor resection during the treatment course
  • Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
  • Core/excisional biopsy of a tumor lesion not previously irradiated has been provided
  • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
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  • Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible
  • Has adequate organ function
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR)
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention
  • Has a life expectancy of at least 6 months
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has squamous cell or undifferentiated gastroesophageal cancer.
  • Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma
  • Has experienced weight loss >20% over 3 months before the first dose of study intervention
  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has Grade ≥2 peripheral neuropathy
Show all 32Show fewer
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention
  • Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
  • Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents
  • Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy
  • Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention
  • Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening
  • Has an active infection requiring systemic therapy
  • Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus [HCV] Ab positive and detectable HCV ribonucleic acid [RNA] infection or a known history of hepatitis B and/or C infection
  • Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study
  • Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication
  • Has poorly controlled diarrhea
  • Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention
  • Has history of allogeneic tissue/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

50 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

50 sites in 12 countries

United States8 sites, 6 recruiting

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)

    East Syracuse, New York, 13057

    Study Coordinator, 315-472-7504

    Recruiting

  • The Cancer and Hematology Centers ( Site 6912)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-975-3065

    Recruiting

  • University of Texas MD Anderson Cancer Center ( Site 6920)

    Houston, Texas, 77030

    Study Coordinator, 833-589-0868

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica ( Site 6905)

    Los Angeles, California, 90404

    Study Coordinator, 310-570-1453

    Recruiting

  • Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)

    Louisville, Kentucky, 40202

    Completed

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)

    New York, New York, 10032

    Completed

  • UPMC Hillman Cancer Center-UPMC ( Site 6904)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 816-898-9413

    Recruiting

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)

    Tucson, Arizona, 85719

    Study Coordinator, 520-621-2449

    Recruiting

Other trials in United States

China8 sites, 7 recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 5500)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, (010)88196317

    Recruiting

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)

    Fuzhou, Fujian, 350025

    Study Coordinator, 0591-22859606

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)

    Hangzhou, Zhejiang, 310016

    Study Coordinator, 0571 8609 0073

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 5514)

    Nanchang, Jiangxi, 330000

    Study Coordinator, 0791-86427234

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 5513)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, （021）6417 5590

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)

    Ürümqi, Xinjiang, 841100

    Active, not recruiting

  • The First Affiliated hospital of Xiamen University ( Site 5503)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2139767

    Recruiting

  • Henan Cancer Hospital ( Site 5504)

    Zhengzhou, Henan, 450008

    Study Coordinator, 400-0371-818

    Recruiting

Other trials in China

Chile7 sites, 6 recruiting

  • Bradford Hill Norte ( Site 6407)

    Antofagasta, 1263521

    Study Coordinator, 56442023631

    Recruiting

  • Clínica Puerto Montt ( Site 6409)

    Port Montt, Los Lagos Region, 5500243

    Study Coordinator, 56961687093

    Recruiting

  • FALP-UIDO ( Site 6400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Centro de Oncología de Precisión-Oncology ( Site 6404)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, 56225189885

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 6405)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, 56934271024

    Recruiting

  • Bradfordhill-Clinical Area ( Site 6401)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • Centro de Investigación del Maule ( Site 6408)

    Talca, Maule Region, 3481349

    Completed

Other trials in Chile

Brazil4 sites, 4 recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 6303)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital Nossa Senhora da Conceição ( Site 6301)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +5551993590437

    Recruiting

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)

    São Paulo, 01246-000

    Study Coordinator, 551138932000

    Recruiting

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)

    São Paulo, 03102-006

    Study Coordinator, 551144500300

    Recruiting

Other trials in Brazil

Italy4 sites, 4 recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, 0543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)

    Milan, Lombardy, 20133

    Study Coordinator, 0223903807

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 5202)

    Milan, 20132

    Study Coordinator, +390226437615

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana ( Site 5206)

    Pisa, Tuscany, 56126

    Study Coordinator, 050992454

    Recruiting

Other trials in Italy

Taiwan4 sites, 4 recruiting

  • China Medical University Hospital ( Site 6007)

    Taichung, 404

    Study Coordinator, 886422052121x15057

    Recruiting

  • National Cheng Kung University Hospital ( Site 6001)

    Tainan, 704

    Study Coordinator, +88662353535x4559

    Recruiting

  • National Taiwan University Hospital-Oncology ( Site 6000)

    Taipei, 10048

    Study Coordinator, +88623123456x267852

    Recruiting

  • Taipei Veterans General Hospital ( Site 6005)

    Taipei, 112

    Study Coordinator, +88628717270x131

    Recruiting

Other trials in Taiwan

Thailand4 sites, 4 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 6102)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194489

    Recruiting

  • Songklanagarind hospital ( Site 6101)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Chulalongkorn Hospital ( Site 6104)

    Pathumwan, Bangkok, 10330

    Study Coordinator, 022564533

    Recruiting

  • Ramathibodi Hospital ( Site 6103)

    Ratchathewi, Bangkok, 10400

    Study Coordinator, 022011671

    Recruiting

Other trials in Thailand

France3 sites, 3 recruiting

  • CHU-BREST Cavale Blanche ( Site 5104)

    Brest, Finistere, 29200

    Study Coordinator, 33298223428

    Recruiting

  • CIC. ( Site 5100)

    Lille, Nord, 59037

    Study Coordinator, +33320445461

    Recruiting

  • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)

    Paris, Île-de-France Region, 75013

    Study Coordinator, +331 42 16 10 41

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)

    Düsseldorf, North Rhine-Westphalia, 40225

    Study Coordinator, +492118108751

    Recruiting

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297

    Study Coordinator, + 4940360352246

    Recruiting

  • NCT-Department of Medical Oncology ( Site 6809)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +49 62215637784

    Recruiting

Other trials in Germany

South Korea2 sites, 2 recruiting

  • Asan Medical Center-Department of Oncology ( Site 5901)

    Seoul, 05505

    Study Coordinator, +82230103217

    Recruiting

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)

    Seoul, 06351

    Study Coordinator, 82234101795

    Recruiting

Other trials in South Korea

Switzerland2 sites, 2 recruiting

  • Kantonsspital Graubünden-Medizin ( Site 6700)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 61 11

    Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 6701)

    Geneva, Canton of Geneva, 1211

    Study Coordinator, +41 22 372 29 01

    Recruiting

Other trials in Switzerland

Norway1 site, 1 recruiting

  • Oslo universitetssykehus, Radiumhospitalet ( Site 6501)

    Oslo, 0379

    Study Coordinator, 4723026600

    Recruiting

Other trials in Norway

About this study

Official title: A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Read the detailed description

The master protocol is MK-3475-U06.

Being tested
Pembrolizumab, Sacituzumab Tirumotecan (sac-TMT), Capecitabine, Leucovorin, Levoleucovorin
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Esophageal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    Administered via intravenous (IV) infusion.

  • Sacituzumab Tirumotecan (sac-TMT)Biological

    Also called MK-2870, SKB264

    Administered via IV infusion.

  • CapecitabineDrug

    Also called XELODA

    Administered via oral tablet.

  • LeucovorinDrug

    Also called calcium folinate, folinic acid, WELLCOVORIN®

    Administered via IV infusion.

  • LevoleucovorinDrug

    Also called calcium levofolinate, levofolinic acid, FUSILEV®

    Administered via IV infusion.

  • 5-Fluorouracil (5-FU)Drug

    Also called ADRUCIL®

    Administered via IV infusion

  • OxaliplatinDrug

    Administered via IV infusion

  • Patritumab DeruxtecanBiological

    Also called HER3-DXd, MK-1022, U3-1402

    Administered via IV infusion

Study groups in NCT06469944
Study groupRoleWhat they receive
Pembrolizumab plus ChemotherapyActive comparatorParticipants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle (Q6W) for up to 18 cycles (up to ~2 years) AND investigator's choice of CAPOX chemotherapy (capecitabine 1000 mg/m^2 orally twice daily for 14 days every 3 weeks (Q3W) and oxaliplatin 130 mg/m^2 via IV infusion Q3W) OR mFOLFOX6 chemotherapy (oxaliplatin 85 mg/m^2 via IV infusion Q3W; 5-Fluorouracil (5-FU) 400 mg/^2 via bolus IV plus 2400 mg/m^2 continuous IV once every 2 weeks (Q2W); and leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W).
Receives: Biological: Pembrolizumab; Drug: Capecitabine; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin
Pembrolizumab plus Sacituzumab Tirumotecan plus ChemotherapyExperimentalParticipants will receive sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W.
Receives: Biological: Pembrolizumab; Biological: Sacituzumab Tirumotecan (sac-TMT); Drug: Capecitabine; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU)
Pembrolizumab plus Patritumab Deruxtecan plus ChemotherapyExperimentalParticipants will receive patritumab deruxtecan via IV infusion on Days 1 and 22 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W.
Receives: Biological: Pembrolizumab; Drug: Capecitabine; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Biological: Patritumab Deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

    DLTs are defined as any treatment-emergent adverse events (TEAEs) not attributable to disease or disease-related processes that occur during the DLT evaluation period and are a Grade 3 or higher according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0. The percentage of participants who experience at least one DLT will be reported.

    Measured: Up to approximately 28 days

  2. Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 28 days

  3. Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 28 days

  4. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants in the analysis population 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 28 months

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. 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. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 55 months

  2. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until 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. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 55 months

  3. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death from any cause.

    Measured: Up to approximately 55 months

  4. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 55 months

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 55 months

  6. Incidence of Antidrug Antibodies (ADA) to investigational agents - (sacituzumab tirumotecan (sac-TMT, MK-2870) and patritumab deruxtecan (HER3-DXd))

    Blood samples collected at designated timepoints will be used to determine the ADA response to investigational agents. The incidence of ADAs over time will be presented.

    Measured: At designated timepoints up to approximately 55 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start20 Sep 2024
  3. Primary completion12 Sep 2029 (estimated)
  4. Study completion12 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06469944
Sponsor's protocol ID
3475-06C
Other IDs
MK-3475-06C, KEYMAKER-06C, 2023-509307-33-00, U1111-1299-8084, 2023
Status last verified
Oct 2026
First submitted
17 Jun 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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