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Cytokine
Interferon Gamma-1b for Mycosis Fungoides and Sezary Syndrome
Phase 2
Waitlist Available
Led By Michael S Khodadoust, MD
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial studies how well pembrolizumab and interferon gamma-1b work together in treating patients with difficult-to-treat mycosis fungoides and Sezary syndrome. Pembrolizumab is a type of antibody that helps the immune system fight cancer.
Eligible Conditions
- Cancer
- Mycosis Fungoides and Sezary Syndrome
- Cutaneous T-Cell Lymphoma
- Inoperable cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Duration of Response (DOR)
Event-free Survival (EFS)
Incidence of Adverse Events
+3 moreOther study objectives
Biomarkers in Tumor and Blood Assessed by Immunohistochemistry, Mass Spectrometry, Nanostring, Sequencing, and Enzyme-linked Immunosorbent Assay
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (pembrolizumab, interferon gamma-1b)Experimental Treatment3 Interventions
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Group II: Group I (pembrolizumab, interferon gamma-1b)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon gamma-1b
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,973 Total Patients Enrolled
Michael S Khodadoust, MDPrincipal InvestigatorCancer Immunotherapy Trials Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must wait at least 2 weeks until any side effects from a previous medical procedure or medication have completely resolved.You have stopped taking medications such as retinoids, interferons, vorinostat, romidepsin and denileukin diftitox for at least 2 weeks before starting the trial.You have received a stem cell transplant from a donor.You have an autoimmune disease that has needed treatment within the past 2 years.You have a medical condition that is not under control.You are pregnant or currently breastfeeding.You are pregnant or breastfeeding.You have mycosis fungoides or Sezary syndrome and are in treatment group I.You have received local radiation therapy at least two weeks before the start of the trial.You have received low-dose Total Skin Electron Beam Therapy (TSEBT) at least 8 weeks ago.Your blood and organs are working properly.You have taken a new or experimental treatment or used a new medical device in the last 4 weeks.You haven't received certain types of cancer treatments for at least 4 weeks (or 16 weeks in the case of alemtuzumab).You have received drugs that target T-cell co-stimulation or checkpoint pathways, such as ipilimumab, at least 15 weeks ago.You have a severe infection that needs to be treated with antibiotics given into your vein (intravenous antibiotics).If you have taken high doses of corticosteroids, you must stop taking them for at least four weeks before enrolling in the trial. However, if you take low or moderate doses, you can participate if you have been on the same dose for at least four weeks before enrollment. You can still use inhaled or topical corticosteroids, and any injections of corticosteroids must be reported.You have advanced stage Mycosis Fungoides or Sezary syndrome that has not responded to at least one standard treatment. The eligibility for the study will depend on the highest stage you have been diagnosed with.You have undergone phototherapy for at least two weeks.You agree to use a reliable form of birth control for 120 days after the last dose of study medication.You have already received chemotherapy treatment in the past.Your condition cannot be treated locally to completely cure it.You have received a monoclonal antibody treatment within the last 4 weeks or have not completely recovered from side effects caused by a treatment taken more than 4 weeks ago.You can't have received any cancer treatment, whether approved or experimental, within 14 days before starting the study.You are currently receiving treatment for cancer other than sarcoma.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (pembrolizumab, interferon gamma-1b)
- Group 2: Group I (pembrolizumab, interferon gamma-1b)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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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