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New shot form of cancer drug tested in 142 patients

NCT ID NCT05017012

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new under-the-skin shot version of the cancer drug pembrolizumab (Keytruda) in 142 people with advanced solid tumors. The goal was to see how well the body absorbs the drug compared to the standard IV infusion. Researchers also checked for side effects and how the shot felt at the injection site.

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

142 people

The number who actually took part.

Started

Sep 2021

Finished

May 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: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor. * Can provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. * Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. * Demonstrates adequate organ function. Exclusion Criteria: * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. * Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention, or has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any adverse events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs). * Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has an active infection requiring therapy. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has known hepatitis B or C infections or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus deoxyribonucleic acid (DNA) or hepatitis C antibody and ribonucleic acid (RNA) * Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study. * Has not fully recovered from any effects of major surgery without significant detectable infection. * Has symptomatic ascites or pleural effusion. * Has preexisting peripheral neuropathy that is \>Grade 2 by latest NCI CTCAE version 5. * Has a known sensitivity to recombinant hyaluronidase or other form of hyaluronidase. * Has a history of severe hypersensitivity reaction (eg, generalized rash/erythema, hypotension, bronchospasm, angioedema, or anaphylaxis) to pemetrexed, cisplatin, axitinib, carboplatin, paclitaxel, or nab-paclitaxel. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.

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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 or metastatic solid tumors

Contacts and locations

Locations

  • Bradfordhill ( Site 0100)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 0051)

    Port Elizabeth, Eastern Cape, 6055, South Africa

  • Cancercare Rondebosch Oncology-Clinical trials ( Site 0055)

    Rondebosch, Western Cape, 7700, South Africa

  • Cape Town Oncology Trials ( Site 0050)

    Cape Town, Western Cape, 7570, South Africa

  • FALP-UIDO ( Site 0101)

    Santiago, Region M. de Santiago, 7500921, Chile

  • HOSPITAL CLÍNIC DE BARCELONA-Department of Medical Oncology ( Site 0043)

    Barcelona, Catalonia, 08036, Spain

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0040)

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Universitario Virgen de la Victoria-Phase I Trials Unit ( Site 0042)

    Málaga, Andalusia, 29010, Spain

  • James Lind Centro de Investigación del Cáncer ( Site 0102)

    Temuco, Araucania, 4800827, Chile

  • Kansai Medical University Hospital ( Site 0112)

    Hirakata, Osaka, 573-1191, Japan

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0052)

    Pretoria, Gauteng, 0181, South Africa

  • Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 0020)

    Budapest, 1062, Hungary

  • Medical Oncology Centre of Rosebank ( Site 0058)

    Johannesburg, Gauteng, 2196, South Africa

  • National Hospital Organization Kyushu Cancer Center ( Site 0114)

    Fukuoka, 811-1395, Japan

  • Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0021)

    Budapest, Pest County, 1122, Hungary

  • Osaka International Cancer Institute ( Site 0113)

    Osaka, 541-8567, Japan

  • Saitama Prefectural Cancer Center ( Site 0110)

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center ( Site 0063)

    Seoul, 06351, South Korea

  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0053)

    Sandton, Gauteng, 2196, South Africa

  • Severance Hospital, Yonsei University Health System ( Site 0062)

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center ( Site 0111)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan

  • Steve Biko Academic Hospital-Medical Oncology ( Site 0057)

    Pretoria, Gauteng, 0001, South Africa

More trials for these conditions

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