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)

Patient preference study for new subcutaneous cancer drug vs. IV

NCT: NCT06099782 · Status: ACTIVE NOT RECRUITING · Phase: Phase 2 · Sponsor: Merck Sharp & Dohme LLC · Started: 2023-12-26 · Est. Completion: 2027-02-15

Plain English Summary

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) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma. This study tests if patients prefer a new way to receive a cancer drug (subcutaneous injection) compared to the current IV infusion. It is for adults with specific types of cancer including lung, kidney, or melanoma. Participants will receive both the new subcutaneous and the current intravenous forms of the drug and will indicate which they prefer. The alternative is the standard intravenous infusion of the same drug. The trial aims to enroll 147 participants.

Official 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. There will be no hypothesis testing in this study.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with confirmed early-stage or advanced/metastatic melanoma, kidney cancer, or non-small cell lung cancer. Patients with lung cancer must have specific genetic markers and PD-L1 levels. Must have a life expectancy of at least 3 months and a good general health status (ECOG 0-1). Certain pre-existing conditions like active autoimmune disease, recent major surgery, or prior treatment with similar immune-boosting drugs may exclude you. This trial is studying Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see which drug delivery method, the new injection or the current infusion, patients like better. The specific primary outcome measures are: Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1 (Day 106). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial matters because it explores a potentially more convenient way for patients to receive a common cancer immunotherapy, aiming to improve the treatment experience. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, where improved treatment options are needed.

Investor Insight

This trial is evaluating a new formulation of a widely used cancer drug, pembrolizumab, which could lead to a more patient-friendly administration route, potentially impacting market share and patient Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this study is right for you, especially regarding your specific cancer type and overall health. Participation involves receiving both the subcutaneous injection and the intravenous infusion of the drug over a period of time. You will be asked to complete questionnaires about your experience and preference for each administration method. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility 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 Locations

Frequently Asked Questions

What is clinical trial NCT06099782?

NCT06099782 is a Phase 2 INTERVENTIONAL study titled "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)." It is currently active, not recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 147 participants.

What conditions does NCT06099782 study?

This trial investigates treatments for Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma. The primary condition under study is Non-Small Cell Lung Cancer.

What treatments are being tested in NCT06099782?

The interventions being studied include: Pembrolizumab (+) Berahyaluronidase alfa (BIOLOGICAL), Pembrolizumab (BIOLOGICAL). Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

What does Phase 2 mean for NCT06099782?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06099782?

This trial is currently "Active, Not Recruiting." It started on 2023-12-26. The estimated completion date is 2027-02-15.

Who is sponsoring NCT06099782?

NCT06099782 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06099782?

The trial aims to enroll 147 participants. The trial status is active, not recruiting.

How is NCT06099782 designed?

This is a interventional study, uses randomized allocation, follows a crossover design, employs none masking.

What are the primary outcomes being measured in NCT06099782?

The primary outcome measures are: Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1 (Day 106). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06099782 being conducted?

This trial is being conducted at 20 sites, including Alexander City, Alabama; Anchorage, Alaska; Springdale, Arkansas; Greenbrae, California and 16 more sites (United States, Argentina, Australia).

Where can I find official information about NCT06099782?

The official record for NCT06099782 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06099782. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06099782 testing in simple terms?

This study tests if patients prefer a new way to receive a cancer drug (subcutaneous injection) compared to the current IV infusion. It is for adults with specific types of cancer including lung, kidney, or melanoma.

Why is this trial significant?

This trial matters because it explores a potentially more convenient way for patients to receive a common cancer immunotherapy, aiming to improve the treatment experience.

What are the potential risks of participating in NCT06099782?

The most common risks are related to the known side effects of pembrolizumab, such as fatigue, rash, and diarrhea. There may be injection site reactions with the subcutaneous formulation, like redness, swelling, or pain. As this is a preference study, there is no guarantee of direct clinical benefit from participating. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06099782?

Ask your doctor if this study is right for you, especially regarding your specific cancer type and overall health. Participation involves receiving both the subcutaneous injection and the intravenous infusion of the drug over a period of time. You will be asked to complete questionnaires about your experience and preference for each administration method. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06099782 signal from an investment perspective?

This trial is evaluating a new formulation of a widely used cancer drug, pembrolizumab, which could lead to a more patient-friendly administration route, potentially impacting market share and patient This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive both the new subcutaneous and the current intravenous forms of the drug and will indicate which they prefer. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.