Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma (NCT03159117) | Clinical Trial Compass
CompletedPhase 1
Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma
United States7 participantsStarted 2017-05-16
Plain-language summary
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06688992. Before this study, PF-06688992 has never been given to people.
PF-06688992 is a targeted therapy for people with cancer. The investigators linked a chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to GD3 which is found on most melanomas but on very few other cells in the body. The investigators hope that in this way, it will deliver this chemotherapy directly to the melanoma and not to normal tissues.
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:
* Histological diagnosis of melanoma confirmed at MSKCC
* Measurable unresectable Stage III or IV Malignant Melanoma and Response Criteria in Solid Tumors \[RECIST\], Version 1.1.
* Patients must have progressed on prior approved checkpoint inhibitor therapy, not tolerated approved checkpoint inhibitor therapy, or have a contraindication to approved checkpoint inhibitors. Patients with stable disease after approved checkpoint inhibitor therapy will also be eligible.
* Patients whose melanomas harbor a BRAF V600E or V600K mutation must have progressed on a RAF inhibitor. Patients who had to discontinue RAF inhibitor therapy because of toxicity but who did not progress will be eligible unless they responded to therapy. In that case, they will not be eligible unless they progress.
* Age ≥ 18 years
* ECOG performance status 0-1.
* Adequate Bone Marrow Function as defined by:
°≥1,500/mm\^3 or ≥ 1.5 x 10\^9/L;
* Platelets ≥ 100,000/mm3 or ≥ 100 x 109/L;
* Hemoglobin ≥ 9 g/dL.
* Adequate Renal Function as defined by:
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN); or
* Estimated creatinine clearance ≥ 60 mL/min as calculated using the method standard for the institution.
* Adequate Liver Function as defined by:
* Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome;
* Aspartate and Alanine Aminotransferase (AST \& ALT) ≤ 2.5 x ULN; ≤ 5.0 x ULN if there is liver involvement secondary to tumor;
* Alkaline …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.