Study on Patient Preference for Subcutaneous vs. Intravenous Pembrolizumab in Various Cancers

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06099782

Provider View

This clinical trial is exploring whether patients prefer receiving pembrolizumab, a cancer treatment, as a subcutaneous injection (under the skin) with hyaluronidase, compared to the traditional intravenous (IV) method. The study includes participants with different types of cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if patients prefer receiving pembrolizumab, a cancer medication, as a subcutaneous injection (under the skin) combined with hyaluronidase, rather than the usual intravenous (IV) method. This study involves participants with various types of cancer, and there will be no hypothesis testing involved.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of early stage or advanced/metastatic solid tumor.
    • For melanoma: Surgically removed Stage IIB, IIC, or III cutaneous melanoma.
    • For renal cell carcinoma (RCC): Surgically removed with intermediate-high or high risk of recurrence.
    • For non-small cell lung cancer (NSCLC): Stage IV with a specific PD-L1 score and no need for certain targeted therapies.
  • Have a life expectancy of at least 3 months.
  • HIV-positive participants must have well-controlled HIV on treatment.
  • Participants with hepatitis B must have undetectable viral load after treatment.
  • Participants with a history of hepatitis C must have completed treatment and have an undetectable viral load.
  • Have a good performance status (ECOG 0 to 1) within 3 days before starting the study.

Exclusion Criteria

  • NSCLC participants with small cell lung cancer or mixed tumors with small cell elements.
  • Melanoma participants with ocular, mucosal, or conjunctival melanoma.
  • RCC participants who had major surgery (other than kidney removal) within 12 weeks before the study.
  • RCC participants who had prior radiotherapy.
  • RCC participants with remaining blood clots after kidney removal.
  • Participants who had previous treatment with certain immune therapies.
  • Participants who had systemic cancer treatment within 4 weeks before the study.
  • Participants who had a live vaccine within 30 days before the study.
  • Participants who had radiotherapy within 2 weeks before the study or have radiation-related side effects needing steroids.
  • Participants who had systemic cancer treatment for metastatic NSCLC, except if it was completed 12 months before diagnosis.
  • Participants who had lung radiation over 30 Gray within 6 months before the study.
  • Participants who used investigational treatments within 4 weeks before the study.
  • Participants with immunodeficiency or on long-term steroid therapy.
  • Participants with another progressing cancer needing treatment in the past 3 years.
  • Participants with active brain metastases or meningitis.
  • Participants with active autoimmune disease needing treatment in the past 2 years.
  • Participants with a history of lung disease needing steroids.
  • Participants with active infections needing treatment.
  • HIV-positive participants with a history of certain diseases.
  • Participants with a history of organ transplant.
  • Participants with severe allergies to pembrolizumab.
  • Participants not fully recovered from major surgery.

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