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 range18 Years
SexALL
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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 …