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

Last updated on July 4, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Unit
Los Angeles, California, 90024 United States
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 HCC who have had
0 to 2 prior lines of systemic therapy (progressed or intolerant to approved HCC
standard of care treatment).

- 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; and have received no more than one line of systemic therapy for
metastatic disease. Patients must not have received immune modifying agents (eg. anti
PD-L1, anti PD-1, anti CTLA4, TNF agonist, etc.) for metastatic disease, or

2. Cutaneous/acral melanoma; and have 1) only previously received systemic therapy for
advanced/metastatic disease with the following therapies: BRAF and MEK inhibitors,
anti PD-L1, anti PD-1, or anti-CTLA4 and 2) have received checkpoint inhibitor (anti
PD-L1, anti PD-1, or anti-CTLA4) based treatment as most recent line of therapy on
which disease progressed, as long as progression did not occur in the first 3 months
of receiving checkpoint inhibitor treatment.

Arm 2 only:

- Histological or cytological diagnosis of NSCLC. Patients must have 1) previously
received prior anti-PD-L1 or anti-PD-1 mAb as most recent therapy, AND 2) did not have
progressive disease as best overall response on recent PD-L1/PD-1 therapy (ie, stable
disease 3 months, PR, or CR), AND 3) who subsequently progressed on anti-PD-L1 or
anti-PD-1 mAb.

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

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Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
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
To 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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Masking Description:
Open-label

Primary Purpose: Treatment

Neoplasms
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
July 21, 2020
November 25, 2018   (Final data collection date for primary outcome measure)

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 HCC who have had 0 to 2 prior lines of systemic therapy (progressed or intolerant to approved HCC standard of care treatment).
  • 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; and have received no more than one line of systemic therapy for metastatic disease. Patients must not have received immune modifying agents (eg. anti PD-L1, anti PD-1, anti CTLA4, TNF agonist, etc.) for metastatic disease, or
  2. Cutaneous/acral melanoma; and have 1) only previously received systemic therapy for advanced/metastatic disease with the following therapies: BRAF and MEK inhibitors, anti PD-L1, anti PD-1, or anti-CTLA4 and 2) have received checkpoint inhibitor (anti PD-L1, anti PD-1, or anti-CTLA4) based treatment as most recent line of therapy on which disease progressed, as long as progression did not occur in the first 3 months of receiving checkpoint inhibitor treatment.

Arm 2 only:

  • Histological or cytological diagnosis of NSCLC. Patients must have 1) previously received prior anti-PD-L1 or anti-PD-1 mAb as most recent therapy, AND 2) did not have progressive disease as best overall response on recent PD-L1/PD-1 therapy (ie, stable disease 3 months, PR, or CR), AND 3) who subsequently progressed on anti-PD-L1 or anti-PD-1 mAb.
  • Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
France,   Japan,   Netherlands,   United States
 
 
NCT02315066
B0601002
2014-004107-75 ( EudraCT Number )
B0601002 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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