Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT06099782

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)

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pembrolizumab (+) Berahyaluronidase alfa

Biological

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

Other names: MK-3475A

Pembrolizumab

Biological

Administered via IV infusion

Other names: MK-3475, KEYTRUDA®

Primary outcomes

  1. 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).

Secondary outcomes

  1. Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3

    Time frame: Day 106

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to ~27 months

    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").

  6. Number of Participants Who Discontinue Study Drug Due to an AE

    Time frame: Up to ~24 months

    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").

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.