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



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 2015
End Date:October 2019

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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.


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)
We found this trial at
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Boston, Massachusetts 02114
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Boston, Massachusetts 02115
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Boston, Massachusetts 02215
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Boston, Massachusetts 02115
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Farmington, Connecticut 06030
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Farmington, Connecticut 06030
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, Texas 77030
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Los Angeles, California 90033
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90024
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Los Angeles, California 90033
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New York, New York 10032
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Newport Beach, California 92658
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Santa Monica, California 90404
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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