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New drug cocktail shows promise against tough cancers

NCT ID NCT06036836

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of two drugs, favezelimab and pembrolizumab (MK-4280A), in 163 people with either a type of skin cancer (cutaneous squamous cell carcinoma) or endometrial cancer. The goal was to see if the treatment could shrink or eliminate tumors. The study is complete, and results will help determine if this approach is worth further study.

What this could mean

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

Active substance
favezelimab/pembrolizumab (MK-4280A)
What this could lead to
If successful, this could point toward a new treatment option for certain skin and endometrial cancers.
What could go wrong
This is an early-phase trial with only 163 participants, so results may not apply broadly. The drug combination may cause side effects or fail to improve outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

163 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2026

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 Cohort A only * Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted) * Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8 * Is systemic treatment naïve * Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided * Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent Cohort B only * Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report * Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation * Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting * Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention) * Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent * Has adequately controlled blood pressure without antihypertensive medication All Cohorts * Agrees to follow contraception guidelines if a participant of childbearing potential * Has a life expectancy \>3 years per investigator assessment * Has adequate organ function * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization * If positive for hepatitis C, has undetectable viral load at screening * If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy Exclusion Criteria: All Cohorts * Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb) * History of allogeneic tissue/solid organ transplant Cohort A only * Received prior radiotherapy to the index lesion (in-field lesion) * Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible Cohort B * Has had major surgery within 3 weeks prior to first dose of study interventions * Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula * Has urine protein ≥1 g/24 hours * Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO) * Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 endometrial cancer endometrium neoplasm skin squamous cell carcinoma

As listed by the trial registrant

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

Cutaneous squamous cell carcinoma Endometrial cancer Solid tumor

Contacts and locations

Locations

  • Ankara Bilkent Şehir Hastanesi ( Site 0427)

    Ankara, 06800, Turkey (Türkiye)

  • Blacktown Hospital ( Site 0003)

    Sydney, New South Wales, 2148, Australia

  • CENTRE LEON BERARD ( Site 0151)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 0154)

    Brest, Finistere, 29200, France

  • Centre Hospitalier de l'Université de Montréal ( Site 0602)

    Montreal, Quebec, H2X 3E4, Canada

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

    Québec, Quebec, G1J 1Z4, Canada

  • Cleveland Clinic Main ( Site 0639)

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute ( Site 0642)

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute ( Site 0641)

    Durham, North Carolina, 27710, United States

  • Erasmus Medisch Centrum ( Site 0272)

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Fiona Stanley Hospital ( Site 0006)

    Murdock, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori-SC Oncologia Medica 3 - Tumori Testa-collo ( Site 025

    Milan, Lombardy, 20133, Italy

  • Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 0424)

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0421)

    Ankara, 06230, Turkey (Türkiye)

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0155)

    Paris, 75014, France

  • Hospital Sultan Ismail-Pusat Rawatan Radioterapi Dan Onkologi ( Site 0063)

    Johor Bahru, Johor, 81100, Malaysia

  • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0153)

    Strasbourg, Alsace, 67200, France

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi

    Naples, 80131, Italy

  • Jewish General Hospital ( Site 0605)

    Montreal, Quebec, H3T 1E2, Canada

  • Liv Hospital Ankara-Oncology ( Site 0426)

    Ankara, 06680, Turkey (Türkiye)

  • McGill University Health Centre ( Site 0604)

    Montreal, Quebec, H4A 3J1, Canada

  • Medipol Mega Universite Hastanesi-oncology ( Site 0425)

    Stanbul, Istanbul, 34214, Turkey (Türkiye)

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0032)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 0031)

    Taipei, 10002, Taiwan

  • Princess Margaret Cancer Centre ( Site 0606)

    Toronto, Ontario, M5G 2M9, Canada

  • Radboudumc ( Site 0274)

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Royal Brisbane and Women's Hospital ( Site 0002)

    Brisbane, Queensland, 4029, Australia

  • Royal North Shore Hospital ( Site 0008)

    St Leonards, New South Wales, 2065, Australia

  • Rutgers Cancer Institute of New Jersey ( Site 0635)

    New Brunswick, New Jersey, 08903, United States

  • Sarawak General Hospital-Radiotherapy Unit ( Site 0062)

    Kuching, Sarawak, 93586, Malaysia

  • St Vincent's Hospital-The Kinghorn Cancer Centre ( Site 0005)

    Darlinghurst, New South Wales, 2010, Australia

  • St. Luke's University Health Network ( Site 0636)

    Bethlehem, Pennsylvania, 18015, United States

  • Sunnybrook Research Institute ( Site 0607)

    Toronto, Ontario, M4N 3M5, Canada

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0423)

    Istanbul, 34722, Turkey (Türkiye)

  • Taichung Veterans General Hospital-GYNECOLOGY ( Site 0033)

    Taichung, 407, Taiwan

  • The Alfred Hospital ( Site 0004)

    Melbourne, Victoria, 3004, Australia

  • UPMC Hillman Cancer Center ( Site 0644)

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Medical Center-CRO-Simmons Comprehensive Cancer Center ( Site 0645)

    Dallas, Texas, 75390-9179, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0183)

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Essen ( Site 0185)

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0182)

    Essen, North Rhine-Westphalia, 45147, Germany

  • University Malaya Medical Centre ( Site 0061)

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University Medical Center Groningen ( Site 0273)

    Groningen, 9713GZ, Netherlands

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0643)

    New Haven, Connecticut, 06510, United States

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