Bladder Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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:

Ocular melanoma patients with advanced/metastatic disease, or
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)

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT02315066

Recruitment Status:

Completed

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 23 Locations for this study

See Locations Near You

The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles California, 90025, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
LAC+USC Medical Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Ronald Regan Medical Center
Los Angeles California, 90095, United States
UCLA Hematology & Oncology Clinic
Los Angeles California, 90095, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
Medical Imaging Center of Southern California, Inc.
Santa Monica California, 90403, United States
Santa Monica UCLA Hematology & Oncology Clinic
Santa Monica California, 90404, United States
UConn Health, Pharmacy
Farmington Connecticut, 06030, United States
UConn Health, Neag Comprehensive Cancer Center
Farmington Connecticut, 06030, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Massachusetts General Hospital (MGH)
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital (BWH)
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute (DFCI)
Boston Massachusetts, 02215, United States
Massachusetts General/Chelsea HealthCare Center
Chelsea Massachusetts, 02150, United States
Mass General/North Shore Center for Outpatient Care
Danvers Massachusetts, 01923, United States
Mass General West
Waltham Massachusetts, 02451, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York New York, 10032, United States
Methodist Hospital-Pathology
Houston Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Groupe hospitalier Pitie Salpetriere
Paris , 75013, France
Institut Gustave Roussy
Villejuif , 94805, France
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
The Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands
Slotervaart Hospital/Antoni van Leeuwenhoek
Amsterdam , 1066 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

174

Study ID:

NCT02315066

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider