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Monoclonal Antibodies
Pembrolizumab + Mogamulizumab for Cutaneous T-Cell Lymphoma
Phase 2
Recruiting
Led By Ryan Wilcox
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is combining two drugs for advanced-stage CTCL, each cycle lasting 6 weeks. Patients will be evaluated regularly and get up to 2 years of treatment if necessary. If a complete response is achieved after 2 cycles, treatment will be continued for an additional 6 months.
Who is the study for?
Adults with advanced-stage, relapsed/refractory Cutaneous T-cell Lymphoma (CTCL) who have failed at least one systemic therapy can join. They must have measurable disease not treated by radiation within the last week, be expected to live more than 6 months, and function relatively well daily. Participants need proper organ function and women of childbearing age must test negative for pregnancy and agree to contraception.
What is being tested?
The trial tests a combination of two drugs: Pembrolizumab and Mogamulizumab in patients with CTCL. It's an open-label phase II study where everyone gets both drugs in cycles lasting six weeks. Responses are checked before cycle three and every two cycles after that. Treatment continues unless there's progression or unacceptable side effects for up to two years.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, immune-related issues like inflammation in organs or skin rashes, blood disorders such as low counts leading to increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response Rate
Secondary study objectives
Assess Adverse Events
Best overall Response (BOR)
Duration of response (DOR)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment2 Interventions
Pembrolizumab 400mg via IV over 30 minutes on Day 1 of each cycle (6 weeks) Mogamulizumab 1mg/kg via IV over a least 60 minutes Cycle 1: Days 1, 8, 15, and 22 Cycle 2+: Days 1, 15, and 29 Each cycle lasts 6 weeks with a maximum of 18 cycles If a subject achieves a complete response (CR) after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR they may discontinue study treatment and enter an observation period. Subjects who progress during the observation period may be eligible for up to an additional 12 cycles of pembrolizumab and mogamulizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Mogamulizumab
2016
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,261 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,888 Total Patients Enrolled
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,733 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can provide tissue samples from a previous procedure or am willing to undergo a biopsy.I've had at least one systemic therapy for cancer and recovered from its side effects.My recent tests show my organs are functioning well.I have not been treated with drugs like pembrolizumab or mogamulizumab.I have not had active treatment for another cancer, except skin or in situ cancers, in the last 2 years.I have cancer that can be measured and hasn't been treated with radiation recently.I have been mostly active and able to carry out all my work or activities up until a week ago.I have active Hepatitis B or C, or both.I am of childbearing age and have a recent negative pregnancy test.I have had a solid organ transplant.I haven't needed systemic treatment for autoimmune or inflammatory disorders in the last 2 years, except for vitiligo or alopecia.I haven't had a live vaccine in the last 30 days, but I may have had mRNA or inactivated vaccines.My skin cancer is confirmed as cutaneous T-cell lymphoma at stage IIB-IVB.I am not on high-dose steroids or other drugs that weaken my immune system.I am on low-dose steroids or used short-term steroids recently.I have not had radiation therapy in the week before starting the trial.I have a condition affecting my brain or spinal cord but meet all other trial requirements.I am currently on medication for an infection.I have had a stem cell transplant or cell therapy and recently used drugs to suppress my immune system.I have or had lung inflammation not caused by infection that needed steroids.I understand and can follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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