Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary… (NCT04960618) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome
United States14 participantsStarted 2021-10-01
Plain-language summary
The purpose of this study is to find out whether the combination of pembrolizumab and gemcitabine is an effective treatment for mycosis fungoides and Sézary syndrome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed mycosis fungoides/Sezary syndrome, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher.
* Age ≥ 18 years.
* ECOG Performance Score between 0-1
* Receipt of at least one prior systemic therapy for MF/SS.
* Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy.
* Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering.
* Prior therapy with gemcitabine allowed.
* Refer to Table 1 for laboratory inclusion criteria.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP) as defined in Appendix C
* A WOCBP who agrees to follow the contraceptive guidance in Appendix C
* A male participant must agree to use a contraception as detailed in Appendix C of this protocol from screening and through 6 months after the last dose of gemcitabine or 120 days after the last dose of pembrolizumab (whichever is la…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines pembrolizumab, an immunotherapy drug, with gemcitabine, a chemotherapy drug — can you explain why using both together might matter for my specific type of mycosis fungoides or Sézary syndrome, and whether that combination makes sense given where my disease is right now?
2Since this is a Phase 2 trial, the main thing being measured is whether the treatment causes tumors to shrink or the disease to respond — what does that mean in terms of how much we'd know about long-term safety and lasting benefit if I were to consider something like this?
3The trial is no longer enrolling new patients, so I can't join it — but based on what this study is testing, are there other active trials or approved treatments using pembrolizumab or gemcitabine for advanced mycosis fungoides or Sézary syndrome that might be worth looking into for my situation?
4Given that this trial focuses on 'advanced' disease, how does my current disease stage compare to what this trial was targeting, and does that affect which treatment options you'd recommend we prioritize?
5Are there any known risks or side effects from combining an immune checkpoint inhibitor like pembrolizumab with chemotherapy like gemcitabine that I should specifically ask about when evaluating any similar treatment paths you might suggest?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.