Non-Small Cell Lung CancerPhase 2NCT06099782
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)
A Phase 2 study testing Pembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab in people with Non-Small Cell Lung Cancer and Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 45 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] administered subcutaneously (SC) over pembrolizumab [MK-3475] administered intravenously (IV) in participants with multiple tumor types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
- What is being tested?
- Pembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 45 sitesin 10 countries
- Study dates
- 26 Dec 2023to 15 Feb 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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 locations and contacts
45 sites in 10 countries.
45 sites in 10 countries
United States8 sites
Russell Medical ( Site 0160)
Alexander City, Alabama, 35010
Alaska Oncology and Hematology ( Site 0121)
Anchorage, Alaska, 99508
Holy Cross Hospital-Clinical Research ( Site 0159)
Fort Lauderdale, Florida, 33308
Marin Cancer Care ( Site 0148)
Greenbrae, California, 94904
Kadlec Clinic Hematology and Oncology ( Site 0103)
Kennewick, Washington, 99336
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
Marietta, Georgia, 30060
Mid Florida Hematology and Oncology Center ( Site 0113)
Orange City, Florida, 32763
Highlands Oncology Group-Research Department ( Site 0133)
Springdale, Arkansas, 72762
South Africa8 sites
Cape Town Oncology Trials ( Site 0802)
Cape Town, Western Cape, 7570
CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)
Cape Town, Western Cape, 7700
Medical Oncology Centre of Rosebank ( Site 0805)
Johannesburg, Gauteng, 2196
Nosworthy Oncology ( Site 0807)
Johannesburg, Gauteng, 2196
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
Port Elizabeth, Eastern Cape, 6045
Steve Biko Academic Hospital-Medical Oncology ( Site 0804)
Pretoria, Gauteng, 0001
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
Pretoria, Gauteng, 0181
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)
Sandton, Gauteng, 2196
Chile7 sites
Clínica Puerto Montt ( Site 0404)
Port Montt, Los Lagos Region, 5500243
FALP-UIDO ( Site 0401)
Santiago, Region M. de Santiago, 7500921
Oncovida ( Site 0403)
Santiago, Region M. de Santiago, 7500994
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
Santiago, Region M. de Santiago, 8330032
Bradfordhill-Clinical Area ( Site 0402)
Santiago, Region M. de Santiago, 8420383
Centro Investigacion Cancer James Lind ( Site 0408)
Temuco, Araucania, 4800827
ONCOCENTRO APYS-ACEREY ( Site 0400)
Viña del Mar, Valparaiso, 2520598
France5 sites
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
Caen, Calvados, 14000
Clinique Francois Chenieux ( Site 0603)
Limoges, Haute-Vienne, 87039
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Hôpital Bichat - Claude-Bernard ( Site 0605)
Paris, Île-de-France Region, 75018
HIA Sainte Anne-Pneumology ( Site 0601)
Toulon, Var, 83800 Cedex 9
Poland4 sites
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Koszalin, West Pomeranian Voivodeship, 75-581
Zachodniopomorskie Centrum Onkologii ( Site 0703)
Szczecin, West Pomeranian Voivodeship, 71-730
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warsaw, Masovian Voivodeship, 02-781
Turkey (Türkiye)4 sites
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
Adana, 01140
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
Ankara, 06230
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
Ankara, 06800
Ege Universitesi Hastanesi ( Site 0902)
Izmir, 35100
Argentina3 sites
Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., C1426ABP
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, B7600FZO
Instituto San Marcos ( Site 0305)
San Juan, J5400EBB
Australia2 sites
Frankston Hospital-Oncology and Haematology ( Site 1007)
Frankston, Victoria, 3199
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Port Macquarie, New South Wales, 2444
Japan2 sites
Bell Land General Hospital ( Site 1101)
Sakai, Osaka, 599-8247
Tokyo Women's Medical University ( Site 1100)
Tokyo, 162-8666
New Zealand2 sites
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Auckland, 1023
Bowen Hospital ( Site 1050)
Wellington, 6035
About this study
Official title: A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] 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.
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
- Being tested
- Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab (+) Berahyaluronidase alfaBiological
Also called MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
Administered via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV | Experimental | In the Treatment Crossover Period: participants will first receive pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC). Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa; Biological: Pembrolizumab |
| Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC | Active comparator | In the Treatment Crossover Period: participants will first receive pembrolizumab IV for three 21-day cycles, followed by pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC). Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1
The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate [PPR]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).
Measured: Day 106
Secondary outcomes (6)
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Measured: Day 106
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
The TASQ SC is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with SC administration, experiences related to administration, convenience, and time. The TASQ SC does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ SC evaluates participants' satisfaction or dissatisfaction with SC administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-SC Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Measured: Up to approximately Day 106
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, and time. The TASQ IV does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-IV Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Measured: Up to approximately Day 106
Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire
The Participant Choice Questionnaire offered participants SC or IV treatment administration choices for the Treatment Continuation Period of the study, and was administered on Day 106 after study intervention administration. As pre-specified by the sSAP, the percentage of participants who chose either SC or IV treatment for the Treatment Continuation Period in the study was reported out of all randomized participants who chose to receive treatment intervention in the Treatment Continuation Period.
Measured: Day 106
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who experience an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").
Measured: Up to ~27 months
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who discontinue study drug due to an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").
Measured: Up to ~24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start26 Dec 2023
- Primary completion9 Apr 2025
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099782
- Sponsor's protocol ID
- 3475A-F11
- Other IDs
- 2023-506017-22-00, U1111-1293-0814, MK-3475A-F11, jRCT2051230147, 2023
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2023
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Casarini IA, Kowalski DM, Caglevic C, Karaca Yayla B, Sumbul AT, Yanez Weber P, Yanzi Castilla AN, Bylicki O, Takagi T, McQuarrie K, Saraf S, Arunachalam A, Bhagwati N, Cohen G. Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. JCO Oncol Pract. 2026 Jun 3:OP2501248. doi: 10.1200/OP-25-01248. Online ahead of print.
PubMed 42234938
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)
- ClinicalTrials.gov ID
- NCT06099782
- Acronym / sponsor ID
- 3475A-F11
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV | Experimental | Biological: Pembrolizumab (+) Berahyaluronidase alfa, Biological: PembrolizumabIn the Treatment Crossover Period: participants will first receive pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC). |
| Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC | Active comparator | Biological: Pembrolizumab (+) Berahyaluronidase alfa, Biological: PembrolizumabIn the Treatment Crossover Period: participants will first receive pembrolizumab IV for three 21-day cycles, followed by pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to ~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to ~2 years) for non-small cell lung cancer (NSCLC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab (+) Berahyaluronidase alfaAlso: MK-3475AFixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection. | Biological | Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV, Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC |
| PembrolizumabAlso: MK-3475, KEYTRUDA®Administered via IV infusion | Biological | Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV, Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC |
Primary outcome
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1
Time frame: Day 106
The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate [PPR]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).
6 secondary outcomes
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
Time frame: Day 106
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Time frame: Up to approximately Day 106
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Time frame: Up to approximately Day 106
Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire
Time frame: Day 106
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~27 months
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to ~24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42234938Casarini IA, Kowalski DM, Caglevic C, Karaca Yayla B, Sumbul AT, Yanez Weber P, Yanzi Castilla AN, Bylicki O, Takagi T, McQuarrie K, Saraf S, Arunachalam A, Bhagwati N, Cohen G. Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. JCO Oncol Pract. 2026 Jun 3:OP2501248. doi: 10.1200/OP-25-01248. Online ahead of print.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
45 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab in people with Non-Small Cell Lung Cancer and Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 45 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, South Africa, Chile, France, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1 (time frame: Day 106). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.