Surveillance of the eye and vision in clinical trials of CP-675,206 for metastatic melanoma.
OBJECTIVE
To determine the ocular safety of CP-675,206 (Pfizer, New York, New York, USA), a fully human anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody in clinical trials of immunotherapy of metastatic melanoma.


METHODS
Prospective, nonrandomized study of the eye and vision in phase I/II clinical trials of CP-675,206 in metastatic melanoma conducted at the University of California, Los Angeles.


METHODS
Patients with regional or distant metastatic melanoma were enrolled in phase I/II clinical trials evaluating the safety and antitumor efficacy of CP-675,206 alone or in combination with melanoma antigen peptide-pulsed dendritic cell vaccines. Ophthalmic evaluation was performed at the onset of CP-675,206 immunotherapy (baseline evaluation), two months or more after the onset of CP-675,206 immunotherapy (end-study evaluation), and at two- to three-month intervals thereafter in patients who continued to receive CP-675,206 immunotherapy (poststudy evaluation). Baseline and end-study evaluations included comprehensive ophthalmic examination, psychophysical and electrophysiologic visual function assessment, fundus photography, fluorescein angiography, and visual function assessment.


RESULTS
Twenty patients with metastatic melanoma arising from the skin, mucosa, eye, or unknown site were evaluated. Systemic toxicity attributed to CP-675,206 included dermatologic manifestations, diarrhea, and autoimmune hepatitis with panhypopituitarism. A subset of patients receiving CP-675,206 demonstrated antitumor efficacy with partial response or complete response of metastatic melanoma. Comparison of ophthalmic baseline with end-study evaluations in all 20 patients and limited-term poststudy evaluations showed no adverse effect of CP-675,206 immunotherapy on the eye or vision.


CONCLUSIONS
In this study, CP-675,206 immunotherapy for metastatic melanoma did not adversely affect the eye or vision.
Straatsma
Bradley R
BR
Department of Ophthalmology, Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California 90095, USA. straatsma@jsei.ucla.edu
Nusinowitz
Steven
S
Young
Tara A
TA
Gordon
Lynn K
LK
Chun
Melissa W
MW
Rosen
Colleen
C
Seja
Elisabeth
E
Economou
James S
JS
Glaspy
John A
JA
Bozon
Viviana
V
Gomez-Navarro
Jesus
J
Ribas
Antoni
A
D000069594:Abatacept; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019138:Antibodies, Blocking / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000951:Antigens, Neoplasm / Q000276:immunology; D001005:Anus Neoplasms / Q000473:pathology / Q000628:therapy; D002830:Choroid Neoplasms / Q000473:pathology / Q000628:therapy; D004359:Drug Therapy, Combination; D004585:Electrooculography; D004596:Electroretinography; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D018796:Immunoconjugates / Q000276:immunology*; D007167:Immunotherapy; D058965:MART-1 Antigen; D008297:Male; D008545:Melanoma / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000276:immunology; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D009799:Ocular Physiological Phenomena; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy; D016896:Treatment Outcome; D014785:Vision, Ocular / Q000502:physiology*; D014792:Visual Acuity
D019138:Antibodies, Blocking; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000951:Antigens, Neoplasm; D018796:Immunoconjugates; D058965:MART-1 Antigen; C548667:MLANA protein, human; D009363:Neoplasm Proteins; D000069594:Abatacept; C520704:tremelimumab