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New drug cocktail takes on Hard-to-Treat cancers

NCT ID NCT05853367

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 5 times

Summary

This early-stage trial is testing an experimental drug called MK-0472, alone or combined with the immunotherapy Keytruda or another experimental drug MK-1084, in people with advanced or metastatic solid tumors. The main goals are to check safety, find the right dose, and see how the body handles the drugs. About 178 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-0472 (an experimental drug), pembrolizumab (Keytruda), and MK-1084 (another experimental drug)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the drug will work. Side effects are possible, and the drug may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

95 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\>4 weeks) antiretroviral therapy (ART) * Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit * Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)/ligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma * Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study * Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * History of hyperparathyroidism or hypercalcemia * Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease * Has clinically significant cardiovascular disease * Bullous exfoliative skin disorders of any grade * Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients * Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing * Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event * Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * 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 medication * Has known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has history of allogeneic tissue/solid organ transplant * Have not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 metastatic malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Metastatic solid tumors

Contacts and locations

Locations

  • Bradfordhill ( Site 0702)

    Santiago, Region M. de Santiago, 8420383, Chile

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201)

    Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

  • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)

    Montreal, Quebec, H2X 0A9, Canada

  • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504)

    Madrid, Madrid, Comunidad de, 28050, Spain

  • Centro de Estudios Clínicos SAGA ( Site 0701)

    Santiago, Region M. de Santiago, 7500653, Chile

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)

    Santiago, Region M. de Santiago, 8330034, Chile

  • Département clinique de médecine de laboratoire du CHUM ( Site 0104)

    Montreal, Quebec, H3T 1E2, Canada

  • Fundacion Arturo Lopez Perez ( Site 0700)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Hospital Universitari Vall d'Hebron ( Site 0500)

    Barcelona, 08035, Spain

  • Hospital Virgen del Rocio ( Site 0503)

    Seville, 41013, Spain

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501)

    L'Hospitalet de Llobregat, Catalonia, 08907, Spain

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

    Hackensack, New Jersey, 07601, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Northwestern Memorial Hospital ( Site 0002)

    Chicago, Illinois, 60611, United States

  • Ospedale Regionale Bellinzona e Valli ( Site 0200)

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Princess Margaret Cancer Centre ( Site 0101)

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center ( Site 0301)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0304)

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey ( Site 0005)

    New Brunswick, New Jersey, 08901, United States

  • Shaare Zedek Medical Center ( Site 0303)

    Jerusalem, 9103102, Israel

  • Sheba Medical Center ( Site 0300)

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 0302)

    Tel Aviv, 6423906, Israel

  • The University of Louisville, James Graham Brown Cancer Center ( Site 0004)

    Louisville, Kentucky, 40202, United States

  • Uniwersyteckie Centrum Kliniczne ( Site 0400)

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.