A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

NCT02444793 | Terminated Phase 1 Results

• 1 other identifier: B1641004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 21

Brief Summary

This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLT)

  DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting \>7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade \>=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade \>=3 laboratory abnormalities (other than aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.

  First 2 Cycles (28 days in each cycle)

Secondary Outcomes (31)

• Number of Participants With Treatment-Emergent Adverse Events (All Causalities)

  Day 1 up to 60 days after last dose of study treatment

• Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)

  Day 1 up to 60 days after last dose of study treatment

• Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)

  Day 1 up tp 60 days after last dose of study treatment

• Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4

  Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

• Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4

  Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

Study Arms (1)

PF-05082566 + KW-0761

EXPERIMENTAL

During Parts 1 \& 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.

Drug: PF-05082566; Drug: KW-0761

Interventions

PF-05082566 DRUG

Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.

PF-05082566 + KW-0761

KW-0761 DRUG

Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.

Also known as: KW-0761= Mogamulizumab or POTELIGEO®

PF-05082566 + KW-0761

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.
• Measurable disease by RECIST version 1.1.
• For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).
• Age 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow, renal and liver function.
• Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
• Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.

You may not qualify if:

• Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
• Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.
• Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.
• Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration.
• Live vaccine within 30 days prior to registration.
• Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation.
• History of autoimmune disease or known inflammatory bowel disease.
• Uncontrolled hypertension (blood pressure \>150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval \>470 msec.

Sponsors & Collaborators

• Pfizer: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (21)

UC San Diego Moores Cancer Center

La Jolla, California, 92037-0845, United States

Location

UC San Diego Medical Center - La Jolla(Thornton Hospital)

La Jolla, California, 92037, United States

Location

University Of California / San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Henry Ford Hospital Research Pharmacy

Detroit, Michigan, 48202, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

UNC Cancer Hospital Infusion Pharmacy

Chapel Hill, North Carolina, 27514, United States

Location

UNC Hospitals, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

Tennessee Oncology, PLLC

Gallatin, Tennessee, 37066, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Cohen EEW, Pishvaian MJ, Shepard DR, Wang D, Weiss J, Johnson ML, Chung CH, Chen Y, Huang B, Davis CB, Toffalorio F, Thall A, Powell SF. A phase Ib study of utomilumab (PF-05082566) in combination with mogamulizumab in patients with advanced solid tumors. J Immunother Cancer. 2019 Dec 4;7(1):342. doi: 10.1186/s40425-019-0815-6.

  PMID: 31801624 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

utomilumab; mogamulizumab

Limitations and Caveats

The study was terminated due to marginal efficacy and change in sponsor prioritization. No participants were enrolled in the dose-expansion portion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Michael J Pishvaian, MD, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Esra E Cohen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Dale R Shepard, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 27, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)