Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma

NCT03159117

Last updated date
Study Location
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 phosphatase ≤ 2.5 x ULN; (≤ 5 x ULN in case of bone metastasis).

- QTc interval < 470 msec.

- Recovery from all prior surgical or adjuvant treatment-related toxicities, to Baseline status, or a CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia. Post-surgical pain will not be considered a basis for exclusion.

- Negative serum/urine pregnancy test (for women of childbearing potential).

- Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

- Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with known symptomatic brain metastases requiring steroids.


- Patients with previously diagnosed brain metastases are eligible as long as they do
not require CNS-directed therapy (including corticosteroids). If the patient has had
radiation therapy or surgery, then they should have completed treatment and have
discontinued corticosteroids for at least 2 weeks and must be neurologically stable.


- Patients with uveal melanoma will not be eligible as these tumors show low expression
of GD3.


- Major surgery, radiation therapy or systemic anti-cancer therapy within 2 weeks of
starting study treatment.


- Presence of ≥ Grade 2 peripheral neuropathy.


- Significant prior infusion reaction to monoclonal antibodies that required treatment
with systemic steroids.


- Active and clinically significant bacterial, fungal or viral infection.


- Known infections with hepatitis B (HBV) or hepatitis C (HCV),


- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness not controlled (with undetectable viral load) on HAART
therapy. Patients on HAART with undetectable viral loads may be eligible per PI
judgment.


- Pregnant or breastfeeding; males and females of childbearing potential who are
unwilling or unable to use a highly effective method of contraception as outlined in
this protocol for the duration of the study and for at least 28 days after last dose
of investigational product.


- Patients currently receiving active treatment for melanoma.


- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack.


- Any ongoing cardiac dysrhythmias of NCI CTCAE Grade >2, NCI CTCAE Grade 4 atrial
fibrillation, or QTcF interval >470 msec, except for documented Right Bundle Branch
Block, at screening.


- Chronic Bronchitis or Emphysema requiring oxygen therapy within the last 6 months.


- Other severe acute or chronic medical or psychiatric condition, including recent
(within the past year) or active suicidal ideation or behavior, or laboratory
abnormality or uncontrolled hypertension that may increase the risk associated with
study participation or investigational product administration or may interfere with
the interpretation of study results and, in the judgment of the investigator, would
make the patient inappropriate for entry into this study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

MelanomaStudy Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
NCT01909453
  1. Birmingham, Alabama
  2. Fayetteville, Arkansas
  3. Rogers, Arkansas
  4. Orange County, California
  5. Orange, California
  6. Orange, California
  7. Aurora, Colorado
  8. Denver, Colorado
  9. Chicago, Illinois
  10. Chicago, Illinois
  11. Chicago, Illinois
  12. Chicago, Illinois
  13. Goshen, Indiana
  14. Goshen, Indiana
  15. Grand Rapids, Michigan
  16. Jackson, Mississippi
  17. Hackensack, New Jersey
  18. Rochester, New York
  19. Dallas, Texas
  20. Burlington, Vermont
  21. Burlington, Vermont
  22. Burlington, Vermont
  23. Alexandria, Virginia
  24. Arlington, Virginia
  25. Fairfax, Virginia
  26. Fairfax, Virginia
  27. Falls Church, Virginia
  28. Gainesville, Virginia
  29. Leesburg, Virginia
  30. Woodbridge, Virginia
  31. Wenatchee, Washington
  32. Caba, Buenos Aires
  33. Buenos Aires, Ciudad Autónoma DE Buenosaires
  34. Buenos Aires, Ciudad Autónoma DE Buenosaires
  35. Buenos Aires, Ciudad Autónoma DE Buenosaires
  36. Buenos Aires, Ciudad Autónoma DE Buenosaires
  37. Buenos Aires, Ciudad Autónoma DE Buenosaires
  38. Buenos Aires, Ciudad Autónoma DE Buenosaires
  39. Gateshead, New South Wales
  40. Southport, Queensland
  41. Southport, Queensland
  42. Southport, Queensland
  43. Woolloongabba, Queensland
  44. Prahran, Victoria
  45. Nedlands, Western Australia
  46. Recife, Pernambuco
  47. Ijuí, RIO Grande DO SUL
  48. Porto Alegre, RIO Grande DO SUL
  49. Barretos, SAO Paulo
  50. Natal,
  51. Rio de Janeiro,
  52. Sao Paulo,
  53. Calgary, Alberta
  54. Toronto, Ontario
  55. Toronto, Ontario
  56. Toronto, Ontario
  57. Montreal, Quebec
  58. Montreal, Quebec
  59. Montreal, Quebec
  60. Montreal, Quebec
  61. Québec, Quebec
  62. Bogotá, Distrito Capital DE Bogotá
  63. Bogotá, Pbx (57-1)
  64. Brno, Jihomoravský KRAJ
  65. Praha 10, Praha, Hlavní Mesto
  66. Praha 2, Praha, Hlavní Mesto
  67. Brno,
  68. Olomouc,
  69. Ostrava Poruba,
  70. Praha,
  71. Nice, Alpes-maritimes
  72. Bordeaux, Gironde
  73. Grenoble, Isère
  74. Reims, Marne
  75. Lille, Nord
  76. Lyon, Rhone
  77. Lyon, Rhône
  78. Le Mans, Sarthe
  79. Villejuif, Val-de-marne
  80. Boulogne-Billancourt,
  81. Lille,
  82. Lyon,
  83. Nice,
  84. Paris,
  85. Paris,
  86. Paris,
  87. Paris,
  88. Pierre-bénite,
  89. Strasbourg,
  90. Templemars,
  91. Villejuif,
  92. Freiburg im Breisgau, Baden-württemberg
  93. Heidelberg, Baden-württemberg
  94. Mannheim, Baden-württemberg
  95. Tübingen, Baden-württemberg
  96. Ulm, Baden-württemberg
  97. München, Bayern
  98. Regensburg, Bayern
  99. Regensburg, Bayern
  100. Würzburg, Bayern
  101. Frankfurt, Hessen
  102. Kassel, Hessen
  103. Kassel, Hessen
  104. Buxtehude, Niedersachsen
  105. Buxtehude, Niedersachsen
  106. Bonn, Nordrhein-westfalen
  107. Minden, Nordrhein-westfalen
  108. Minden, Nordrhein-westfalen
  109. Mainz, Rheinland-pfalz
  110. Magdeburg, Sachsen-anhalt
  111. Dresden, Sachsen
  112. Leipzig, Sachsen
  113. Berlin, Schleswig-holstein
  114. Lübeck, Schleswig-holstein
  115. Berlin,
  116. Bonn,
  117. Dresden,
  118. Dresden,
  119. Erfurt,
  120. Erfurt,
  121. Essen,
  122. Freiburg,
  123. Gera,
  124. Gera,
  125. Gera,
  126. Hamburg,
  127. Hannover,
  128. Hannover,
  129. Hannover,
  130. Heidelberg,
  131. Homburg,
  132. Kiel,
  133. Lübeck,
  134. Magdeburg,
  135. Magdeburg,
  136. Mainz,
  137. Mannheim,
  138. Minden,
  139. Münster,
  140. Nürnberg,
  141. Regensburg,
  142. Tübingen,
  143. Ulm,
  144. Ulm,
  145. Athens, Attiki
  146. Athens,
  147. Athens,
  148. Athens,
  149. Budapest,
  150. Budapest,
  151. Debrecen,
  152. Szolnok,
  153. Ramat Gan, Tel-aviv
  154. Haifa,
  155. Jerusalem,
  156. Napoli, Campania
  157. Roma, Lazio
  158. Roma, Lazio
  159. Lecco, Lombardia
  160. Milan, Lombardia
  161. Monza, Lombardia
  162. Rozzano, Lombardia
  163. Rozzano, Lombardia
  164. Candiolo, Torino
  165. Pisa, Toscana
  166. Terni, Umbria
  167. Padua, Veneto
  168. Ancona,
  169. Bari,
  170. Bergamo,
  171. Bologna,
  172. Genova,
  173. Milano,
  174. Napoli,
  175. Padova,
  176. Pavia,
  177. Ragusa,
  178. Siena,
  179. Torino,
  180. Fukuoka-shi, Fukuoka
  181. Matsumoto, Nagano
  182. Chuo-ku, Tokyo
  183. Niigata,
  184. Osaka, Ôsaka
  185. Gangnam-Gu, Seoul Teugbyeolsi
  186. Songpa-Gu, Seoul Teugbyeolsi
  187. Seoul,
  188. Seoul,
  189. Seoul,
  190. Seoul,
  191. Mexico,
  192. Mexico,
  193. Nijmegen, Gelderland
  194. Heerlen, Limburg
  195. Amsterdam, Noord Holland
  196. Breda, Noord-brabant
  197. Eindhoven, Noord-brabant
  198. Veldhoven, Noord-brabant
  199. Zwolle, Overijssel
  200. Enschede,
  201. Groningen,
  202. Leiden,
  203. Maastricht,
  204. Rotterdam,
  205. Rotterdam,
  206. Sittard-Geleen,
  207. Oslo,
  208. Oslo,
  209. Oslo,
  210. Warsaw, Mazowieckie
  211. Warszawa, Mazowieckie
  212. Warszawa,
  213. Lisbon, Lisboa
  214. Porto, Proto
  215. Almada,
  216. Lisboa,
  217. Lisboa,
  218. Lisboa,
  219. Lisboa,
  220. Porto,
  221. Moscow,
  222. St. Petersburg,
  223. Singapore,
  224. Singapore,
  225. Singapore,
  226. Bratislava,
  227. Bratislava,
  228. Bratislava,
  229. Poprad,
  230. Pretoria,
  231. Pretoria,
  232. Jerez De La Frontera, Andalucía
  233. Oviedo, Asturias
  234. Barcelona, Cataluña
  235. El Palmar, Murcia
  236. Pamplona, Navarra
  237. Pamplona, Navarra
  238. Alicante,
  239. Badalona,
  240. Barcelona,
  241. Barcelona,
  242. Barcelona,
  243. Barcelona,
  244. Donostia-san Sebastián,
  245. Dos Hermanas,
  246. Granada,
  247. La Coruna,
  248. Lleida,
  249. Lleida,
  250. Madrid,
  251. Madrid,
  252. Madrid,
  253. Majadahonda,
  254. Malaga,
  255. Sevilla,
  256. Sevilla,
  257. Sevilla,
  258. Valencia,
  259. Göteborg,
  260. Lund,
  261. Solna,
  262. Uppsala,
  263. Zurich, Zürich (DE)
  264. Bern,
  265. Zürich,
  266. Zürich,
  267. Zürich,
  268. Bornova,
  269. Izmir,
  270. Izmir,
  271. Cambridge, Cambridgeshire
  272. Preston, Lancashire
  273. London, London, CITY OF
  274. Oxford, Oxfordshire
  275. Guildford, Surrey
  276. Bebington, Wirral
  277. Sheffield, York
  278. Broomfield,
  279. Leeds,
  280. London,
  281. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
MelanomaPfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma
NCT03159117
  1. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
MelanomaPhase I Oncovir Poly IC:LC and NY-ESO-1/gp100
NCT01008527
  1. Tampa, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
MelanomaA Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma
NCT02400385
  1. San Francisco, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma
Official Title  ICMJE A Phase I Open-Label Dose Escalation of GD3 ADC (Pfizer PF-06688992) in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma (B802WI209568)
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a Phase 1 non-randomized, open-label, single-center, single-arm multiple dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE Drug: PF-06688992
(PF-06688992) will be administered on Day 1 of each 21-day cycle per the Dose Preparation and Administration Instructions (DAI) located in the Investigational Product Manual (Appendix 4Appendix 3) as an IV infusion over approximately 60 minutes. A cycle is defined as the time from Day 1 dose to the next Day 1 dose. If there are no treatment delays, a cycle will be 21 days. Each patient may receive PF-06688992 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
Other Name: GD3 ADC
Study Arms  ICMJE Experimental: PF 06688992
This clinical study will be a dose-finding phase I study in which patients will be treated with various doses of Pfizer PF-06688992 using a Bayesian dose escalation scheme.
Intervention: Drug: PF-06688992
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2017)
40
Actual Study Completion Date  ICMJE January 10, 2020
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 phosphatase ? 2.5 x ULN; (? 5 x ULN in case of bone metastasis).
  • QTc interval < 470 msec.
  • Recovery from all prior surgical or adjuvant treatment-related toxicities, to Baseline status, or a CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia. Post-surgical pain will not be considered a basis for exclusion.
  • Negative serum/urine pregnancy test (for women of childbearing potential).
  • Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
  • Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria:

  • Patients with known symptomatic brain metastases requiring steroids.
  • Patients with previously diagnosed brain metastases are eligible as long as they do not require CNS-directed therapy (including corticosteroids). If the patient has had radiation therapy or surgery, then they should have completed treatment and have discontinued corticosteroids for at least 2 weeks and must be neurologically stable.
  • Patients with uveal melanoma will not be eligible as these tumors show low expression of GD3.
  • Major surgery, radiation therapy or systemic anti-cancer therapy within 2 weeks of starting study treatment.
  • Presence of ? Grade 2 peripheral neuropathy.
  • Significant prior infusion reaction to monoclonal antibodies that required treatment with systemic steroids.
  • Active and clinically significant bacterial, fungal or viral infection.

    • Known infections with hepatitis B (HBV) or hepatitis C (HCV),
    • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness not controlled (with undetectable viral load) on HAART therapy. Patients on HAART with undetectable viral loads may be eligible per PI judgment.
  • Pregnant or breastfeeding; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
  • Patients currently receiving active treatment for melanoma.
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack.
  • Any ongoing cardiac dysrhythmias of NCI CTCAE Grade >2, NCI CTCAE Grade 4 atrial fibrillation, or QTcF interval >470 msec, except for documented Right Bundle Branch Block, at screening.
  • Chronic Bronchitis or Emphysema requiring oxygen therapy within the last 6 months.
  • Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality or uncontrolled hypertension that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03159117
Other Study ID Numbers  ICMJE 17-165
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Paul Chapman, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP