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Clinical Trial Finder

Search Results

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

Study Purpose

The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa administered subcutaneously (SC) over pembrolizumab (MK-3475) administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06099782
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Argentina, Australia, Chile, France, Japan, New Zealand, Poland, South Africa, Turkey (Türkiye), United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV

In the treatment crossover period, participants will receive pembrolizumab (+) berahyaluronidase alfa SC followed by pembrolizumab IV. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for renal cell carcinoma (RCC) and melanoma and for up to ~2 years for non-small cell lung cancer (NSCLC).

Active Comparator: Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC

In the treatment crossover period, participants will receive pembrolizumab IV followed by pembrolizumab (+) berahyaluronidase alfa SC. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for RCC and melanoma and for up to ~2 years for NSCLC.

Interventions

Biological: - Pembrolizumab (+) Berahyaluronidase alfa

Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

Biological: - Pembrolizumab

Administered via IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Russell Medical ( Site 0160), Alexander City 4829843, Alabama 4829764

Status

Address

Russell Medical ( Site 0160)

Alexander City 4829843, Alabama 4829764, 35010

Anchorage 5879400, Alaska 5879092

Status

Address

Alaska Oncology and Hematology ( Site 0121)

Anchorage 5879400, Alaska 5879092, 99508

Springdale 4132093, Arkansas 4099753

Status

Address

Highlands Oncology Group-Research Department ( Site 0133)

Springdale 4132093, Arkansas 4099753, 72762

Marin Cancer Care ( Site 0148), Greenbrae 5354013, California 5332921

Status

Address

Marin Cancer Care ( Site 0148)

Greenbrae 5354013, California 5332921, 94904

Fort Lauderdale 4155966, Florida 4155751

Status

Address

Holy Cross Hospital-Clinical Research ( Site 0159)

Fort Lauderdale 4155966, Florida 4155751, 33308

Orange City 4167055, Florida 4155751

Status

Address

Mid Florida Hematology and Oncology Center ( Site 0113)

Orange City 4167055, Florida 4155751, 32763

Marietta 4207783, Georgia 4197000

Status

Address

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

Marietta 4207783, Georgia 4197000, 30060

Kennewick 5799610, Washington 5815135

Status

Address

Kadlec Clinic Hematology and Oncology ( Site 0103)

Kennewick 5799610, Washington 5815135, 99336

International Sites

Mar del Plata 3430863, Buenos Aires 3435907, Argentina

Status

Address

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

Mar del Plata 3430863, Buenos Aires 3435907, B7600FZO

Fundación Respirar ( Site 0302), Buenos Aires 3435910, Buenos Aires F.D. 3433955, Argentina

Status

Address

Fundación Respirar ( Site 0302)

Buenos Aires 3435910, Buenos Aires F.D. 3433955, C1426ABP

Instituto San Marcos ( Site 0305), San Juan 3837213, Argentina

Status

Address

Instituto San Marcos ( Site 0305)

San Juan 3837213, , J5400EBB

Port Macquarie 2152659, New South Wales 2155400, Australia

Status

Address

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

Port Macquarie 2152659, New South Wales 2155400, 2444

Frankston 2166144, Victoria 2145234, Australia

Status

Address

Frankston Hospital-Oncology and Haematology ( Site 1007)

Frankston 2166144, Victoria 2145234, 3199

Clínica Puerto Montt ( Site 0404), Port Montt 3874960, Los Lagos Region 3881974, Chile

Status

Address

Clínica Puerto Montt ( Site 0404)

Port Montt 3874960, Los Lagos Region 3881974, 5500243

FALP-UIDO ( Site 0401), Santiago 3871336, Region M. de Santiago, Chile

Status

Address

FALP-UIDO ( Site 0401)

Santiago 3871336, Region M. de Santiago, 7500921

Oncovida ( Site 0403), Santiago 3871336, Region M. de Santiago, Chile

Status

Address

Oncovida ( Site 0403)

Santiago 3871336, Region M. de Santiago, 7500994

Santiago 3871336, Region M. de Santiago, Chile

Status

Address

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

Santiago 3871336, Region M. de Santiago, 8330032

Bradfordhill-Clinical Area ( Site 0402), Santiago 3871336, Region M. de Santiago, Chile

Status

Address

Bradfordhill-Clinical Area ( Site 0402)

Santiago 3871336, Region M. de Santiago, 8420383

Temuco 3870011, Región de la Araucanía 3899463, Chile

Status

Address

Centro Investigacion Cancer James Lind ( Site 0408)

Temuco 3870011, Región de la Araucanía 3899463, 4800827

ONCOCENTRO APYS-ACEREY ( Site 0400), Viña del Mar 3868121, Región de Valparaíso 3868621, Chile

Status

Address

ONCOCENTRO APYS-ACEREY ( Site 0400)

Viña del Mar 3868121, Región de Valparaíso 3868621, 2520598

Caen 3029241, Calvados, France

Status

Address

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

Caen 3029241, Calvados, 14000

Clinique Francois Chenieux ( Site 0603), Limoges 2998286, Haute-Vienne, France

Status

Address

Clinique Francois Chenieux ( Site 0603)

Limoges 2998286, Haute-Vienne, 87039

Lyon Cedex08, Rhone-Alpes, France

Status

Address

CENTRE LEON BERARD-onco dermatology ( Site 0600)

Lyon Cedex08, Rhone-Alpes, 69373

HIA Sainte Anne-Pneumology ( Site 0601), Toulon 2972328, Var, France

Status

Address

HIA Sainte Anne-Pneumology ( Site 0601)

Toulon 2972328, Var, 83800 Cedex 9

Paris 2988507, Île-de-France Region 3012874, France

Status

Address

Hôpital Bichat - Claude-Bernard ( Site 0605)

Paris 2988507, Île-de-France Region 3012874, 75018

Bell Land General Hospital ( Site 1101), Sakai 1853195, Osaka 1853904, Japan

Status

Address

Bell Land General Hospital ( Site 1101)

Sakai 1853195, Osaka 1853904, 599-8247

Tokyo 1850147, Japan

Status

Address

Tokyo Women's Medical University ( Site 1100)

Tokyo 1850147, , 162-8666

Auckland 2193733, New Zealand

Status

Address

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

Auckland 2193733, , 1023

Bowen Hospital ( Site 1050), Wellington 2179537, New Zealand

Status

Address

Bowen Hospital ( Site 1050)

Wellington 2179537, , 6035

Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500, Poland

Status

Address

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

Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500, 85-796

Warsaw 756135, Masovian Voivodeship 858787, Poland

Status

Address

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

Warsaw 756135, Masovian Voivodeship 858787, 02-781

Koszalin 3095049, West Pomeranian Voivodeship 3337499, Poland

Status

Address

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

Koszalin 3095049, West Pomeranian Voivodeship 3337499, 75-581

Szczecin 3083829, West Pomeranian Voivodeship 3337499, Poland

Status

Address

Zachodniopomorskie Centrum Onkologii ( Site 0703)

Szczecin 3083829, West Pomeranian Voivodeship 3337499, 71-730

Port Elizabeth 964420, Eastern Cape 1085593, South Africa

Status

Address

Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)

Port Elizabeth 964420, Eastern Cape 1085593, 6045

Johannesburg 993800, Gauteng 1085594, South Africa

Status

Address

Medical Oncology Centre of Rosebank ( Site 0805)

Johannesburg 993800, Gauteng 1085594, 2196

Nosworthy Oncology ( Site 0807), Johannesburg 993800, Gauteng 1085594, South Africa

Status

Address

Nosworthy Oncology ( Site 0807)

Johannesburg 993800, Gauteng 1085594, 2196

Pretoria 964137, Gauteng 1085594, South Africa

Status

Address

Steve Biko Academic Hospital-Medical Oncology ( Site 0804)

Pretoria 964137, Gauteng 1085594, 0001

Pretoria 964137, Gauteng 1085594, South Africa

Status

Address

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)

Pretoria 964137, Gauteng 1085594, 0181

Sandton 957654, Gauteng 1085594, South Africa

Status

Address

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

Sandton 957654, Gauteng 1085594, 2196

Cape Town Oncology Trials ( Site 0802), Cape Town 3369157, Western Cape 1085599, South Africa

Status

Address

Cape Town Oncology Trials ( Site 0802)

Cape Town 3369157, Western Cape 1085599, 7570

Cape Town 3369157, Western Cape 1085599, South Africa

Status

Address

CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)

Cape Town 3369157, Western Cape 1085599, 7700

Adana 325363, Turkey (Türkiye)

Status

Address

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

Adana 325363, , 01140

Ankara 323786, Turkey (Türkiye)

Status

Address

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)

Ankara 323786, , 06230

Ankara 323786, Turkey (Türkiye)

Status

Address

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)

Ankara 323786, , 06800

Ege Universitesi Hastanesi ( Site 0902), Izmir 311046, Turkey (Türkiye)

Status

Address

Ege Universitesi Hastanesi ( Site 0902)

Izmir 311046, , 35100

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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