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Cancer drug shot preferred over IV drip in new study

NCT ID NCT06099782

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study looks at whether people with certain cancers (non-small cell lung cancer, kidney cancer, or melanoma) prefer getting the drug pembrolizumab as a quick shot under the skin instead of a longer IV infusion. About 147 participants will try both methods and then say which they like better. The goal is to see if the shot is more convenient and comfortable, not to test if it works better.

What this could mean

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

Active substance
pembrolizumab with hyaluronidase
What this could lead to
If successful, this could offer a faster, more convenient way to receive pembrolizumab as a shot instead of a lengthy IV infusion.
What could go wrong
This is an early-phase study focused on patient preference, not on whether the shot works better or is safer than the IV form. The shot may not be suitable for everyone.

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

147 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Feb 2027

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: * Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type: * Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition. * Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status. * Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy. * Has a life expectancy of at least 3 months. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). * 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 before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention. Exclusion Criteria: * Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Melanoma participants with ocular, mucosal, or conjunctival melanoma. * Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization. * Has received prior radiotherapy for RCC. * RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava. * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. * Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. * Received radiation therapy to the lung that is \>30 Gray within 6 months of start 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 the first dose of study medication. * 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 active autoimmune disease that has required systemic treatment in the past 2 years. * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has active infection requiring systemic therapy. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has history of allogeneic tissue/solid organ transplant corticosteroids. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has not adequately recovered from major surgery or have ongoing surgical complications.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

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

Melanoma Non-small cell lung cancer Renal cell carcinoma

Contacts and locations

Locations

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)

    Adana, 01140, Turkey (Türkiye)

  • Alaska Oncology and Hematology ( Site 0121)

    Anchorage, Alaska, 99508, United States

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)

    Ankara, 06800, Turkey (Türkiye)

  • Auckland City Hospital-Cancer & Blood Research ( Site 1051)

    Auckland, 1023, New Zealand

  • Bell Land General Hospital ( Site 1101)

    Sakai, Osaka, 599-8247, Japan

  • Bowen Hospital ( Site 1050)

    Wellington, 6035, New Zealand

  • Bradfordhill-Clinical Area ( Site 0402)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)

    Cape Town, Western Cape, 7700, South Africa

  • CENTRE LEON BERARD-onco dermatology ( Site 0600)

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

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)

    Port Elizabeth, Eastern Cape, 6045, South Africa

  • Cape Town Oncology Trials ( Site 0802)

    Cape Town, Western Cape, 7570, South Africa

  • Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)

    Caen, Calvados, 14000, France

  • Centro Investigacion Cancer James Lind ( Site 0408)

    Temuco, Araucania, 4800827, Chile

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Clinique Francois Chenieux ( Site 0603)

    Limoges, Haute-Vienne, 87039, France

  • Clínica Puerto Montt ( Site 0404)

    Port Montt, Los Lagos Region, 5500243, Chile

  • Ege Universitesi Hastanesi ( Site 0902)

    Izmir, 35100, Turkey (Türkiye)

  • FALP-UIDO ( Site 0401)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Frankston Hospital-Oncology and Haematology ( Site 1007)

    Frankston, Victoria, 3199, Australia

  • Fundación Respirar ( Site 0302)

    Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina

  • HIA Sainte Anne-Pneumology ( Site 0601)

    Toulon, Var, 83800 Cedex 9, France

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)

    Ankara, 06230, Turkey (Türkiye)

  • Highlands Oncology Group-Research Department ( Site 0133)

    Springdale, Arkansas, 72762, United States

  • Holy Cross Hospital-Clinical Research ( Site 0159)

    Fort Lauderdale, Florida, 33308, United States

  • Hôpital Bichat - Claude-Bernard ( Site 0605)

    Paris, Île-de-France Region, 75018, France

  • Instituto San Marcos ( Site 0305)

    San Juan, J5400EBB, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Kadlec Clinic Hematology and Oncology ( Site 0103)

    Kennewick, Washington, 99336, United States

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)

    Pretoria, Gauteng, 0181, South Africa

  • Marin Cancer Care ( Site 0148)

    Greenbrae, California, 94904, United States

  • Medical Oncology Centre of Rosebank ( Site 0805)

    Johannesburg, Gauteng, 2196, South Africa

  • Mid Florida Hematology and Oncology Center ( Site 0113)

    Orange City, Florida, 32763, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)

    Marietta, Georgia, 30060, United States

  • Nosworthy Oncology ( Site 0807)

    Johannesburg, Gauteng, 2196, South Africa

  • ONCOCENTRO APYS-ACEREY ( Site 0400)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncovida ( Site 0403)

    Santiago, Region M. de Santiago, 7500994, Chile

  • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)

    Santiago, Region M. de Santiago, 8330032, Chile

  • Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)

    Port Macquarie, New South Wales, 2444, Australia

  • Russell Medical ( Site 0160)

    Alexander City, Alabama, 35010, United States

  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)

    Sandton, Gauteng, 2196, South Africa

  • Steve Biko Academic Hospital-Medical Oncology ( Site 0804)

    Pretoria, Gauteng, 0001, South Africa

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Tokyo Women's Medical University ( Site 1100)

    Tokyo, 162-8666, Japan

  • Zachodniopomorskie Centrum Onkologii ( Site 0703)

    Szczecin, West Pomeranian Voivodeship, 71-730, Poland

More trials for these conditions

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