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Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566

Last updated on October 12, 2019

FOR MORE INFORMATION
Study Location
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
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

- Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC,
melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy,
for which no standard therapy is available or who decline standard therapy.

- Part A2 only: Patients with histological or cytological diagnosis of
advanced/metastatic HCC who are treatment naïve and have declined standard of care, or
have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is
allowed.

- Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC,
melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary
bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who
progressed on or are intolerant to standard therapy, for which no standard therapy is
available, or who decline standard therapy.

- Part B2

Arm 1 only:

1. Ocular melanoma patients with advanced/metastatic disease, or

2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received
checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which
disease progressed. [Note: Checkpoint inhibitor may have been part of a combination
therapy, as long as the combination did not contain OX40 or 4 1BB agonist.] Any
questions on prior treatment may be discussed with the Sponsor.

Arm 2 only:

- Histological or cytological diagnosis of NSCLC with advanced/metastatic disease.
Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which
disease progressed. [Note: Previous anti PD L1 or anti PD 1 mAb may have been part of
a combination therapy, eg, in combination with chemotherapy, as long as the
combination did not contain OX40 or 4 1BB agonist.]

- Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function

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

- Brain metastases requiring steroids

- Major surgery, Radiation therapy within 4 weeks of starting study treatment (except:
palliative radiotherapy to a limited field is allowed after consultation with
sponsor's medical monitor at any time during study participation, including during
screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6
weeks for mitomycin C or nitrosoureas)

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

- History of active autoimmune disorders

- History of immune-mediated adverse events requiring immunosuppressive therapy or were
grade 3 or higher related to prior immune-modulatory therapy

- Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)

- Prior anthracycline treatment and at risk of cardiac failure (New York Heart
Association Class 2)

NCT02315066
Pfizer
Active, not recruiting
Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566

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Descriptive Information
Brief Title  ICMJE Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
Official Title  ICMJE A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS
Brief SummaryTo assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Masking Description:
Open-label

Primary Purpose: Treatment

Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: PF-04518600
    Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined
  • Drug: PF-04518600
    Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously
  • Drug: PF-04518600 plus PF-05082566
    Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.
  • Drug: PF-04518600 plus PF-05082566
    Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.
Study Arms  ICMJE
  • Experimental: PF-04518600
    OX40 agonist
    Interventions:
    • Drug: PF-04518600
    • Drug: PF-04518600
  • Experimental: PF-04518600 plus PF-05082566
    OX40 (CD134) agonist plus 4-1BB (CD137) agonist
    Interventions:
    • Drug: PF-04518600 plus PF-05082566
    • Drug: PF-04518600 plus PF-05082566
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 6, 2019)
175
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
180
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion DateApril 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
  • Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.
  • Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
  • Part B2

Arm 1 only:

  1. Ocular melanoma patients with advanced/metastatic disease, or
  2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. [Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.] Any questions on prior treatment may be discussed with the Sponsor.

Arm 2 only:

  • Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. [Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.]
  • Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • Brain metastases requiring steroids
  • Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
  • Active and clinically significant bacterial, fungal, or viral infection
  • History of active autoimmune disorders
  • History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy
  • Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)
  • Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)
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 France,   Japan,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315066
Other Study ID Numbers  ICMJE B0601002
2014-004107-75 ( EudraCT Number )
B0601002 ( Other Identifier: Alias Study Number )
OX40 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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]

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