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

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By email

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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.

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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