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Checkpoint Inhibitor

Subcutaneous vs Intravenous Pembrolizumab for Cancer

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV-infected participants must have well controlled HIV on antiretroviral therapy

Meets specific conditions based on tumor type (e.g., surgically resected Stage IIB and IIC or III cutaneous melanoma, surgically resected renal cell carcinoma with intermediate-high or high risk of recurrence, Stage IV non-small cell lung cancer with specific criteria)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~27 months

Awards & highlights

Study Summary

This trial will compare two ways of administering a cancer drug to see which patients prefer. No hypothesis testing is needed.

Who is the study for?

This trial is for people with certain types of cancer (like lung, melanoma, or kidney) who have a life expectancy of at least 3 months and are in good physical condition. They must not have had severe reactions to pembrolizumab before, no active infections or autoimmune diseases needing recent treatment, and should not be on immunosuppressants.Check my eligibility

What is being tested?

The study compares participant preference between two ways of getting Pembrolizumab: a new method mixed with hyaluronidase given under the skin versus the usual way through an IV. The goal is to see which method patients like more without testing effectiveness.See study design

What are the potential side effects?

Pembrolizumab can cause immune system-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and may worsen existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My HIV is well controlled with medication.

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My cancer type and stage match the trial's specific requirements.

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My cancer is confirmed by a lab test and is in an early or advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1

Secondary outcome measures

Number of Participants Who Experience an Adverse Event (AE)

Number of participants who discontinue study drug due to an AE

Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: MK-3475A SC →Pembrolizumab IVExperimental Treatment2 Interventions

In the treatment crossover period, participants will receive MK-3475A 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).

Group II: Arm B: Pembrolizumab IV→MK-3475A SCActive Control2 Interventions

In the treatment crossover period, participants will receive pembrolizumab IV followed by MK-3475A 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,899 Previous Clinical Trials

5,062,718 Total Patients Enrolled

120 Trials studying Melanoma

21,739 Patients Enrolled for Melanoma

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,783 Previous Clinical Trials

8,065,991 Total Patients Enrolled

35 Trials studying Melanoma

11,160 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on volunteer participation for this clinical research?

"Yes, records on clinicaltrials.gov indicate that this study is currently recruiting subjects. The trial was posted in December 18th of 2023 and last modified on November 21st of the same year. A total 144 patients must be selected from a single site to participate."

Answered by AI

Does this research endeavor continue to accept new participants?

"Indeed, this trial is still recruiting as documented on clinicaltrials.gov. It was initially listed on December 18th 2023 and its details were last adjusted November 21st of the same year."

Answered by AI

Has the FDA granted authorization for Arm A: MK-3475A SC →Pembrolizumab IV?

"Our safety rating of Arm A: MK-3475A SC →Pembrolizumab IV is a 2 due to the presence of data confirming its security, though efficacy has yet to be demonstrated in Phase 2 trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099782.