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BRIEF TITLE: 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 Carcinomas

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


  • Org Study ID: B0601002
  • Secondary ID: 2014-004107-75,B0601002
  • NCT ID: NCT02315066
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: Pfizer

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting April 23, 2015 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with Dose-limiting toxicities (DLT) [Dose Escalation]

Primary Outcome 1 - Time Frame: Day 1 up to Day 28

Primary Outcome 2 - Measure: Overall safety profile [Dose Expansion]

Primary Outcome 2 - Time Frame: Day 1 up to Day 28

Condition:

  • Neoplasms

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:

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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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

Locations

Facility Status Contact
Clinical Research Unit
Los Angeles, California 90024
United States
Recruiting
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California 90025
United States
Recruiting
Keck Hospital of USC
Los Angeles, California 90033
United States
Recruiting
LAC+USC Medical Center
Los Angeles, California 90033
United States
Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Recruiting
Ronald Regan Medical Center
Los Angeles, California 90095
United States
Recruiting
UCLA Hematology & Oncology Clinic
Los Angeles, California 90095
United States
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Recruiting
Medical Imaging Center of Southern California, Inc.
Santa Monica, California 90403
United States
Recruiting
Santa Monica UCLA Hematology & Oncology Clinic
Santa Monica, California 90404
United States
Recruiting
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Santa Monica, California 90404
United States
Recruiting
UConn Health, Pharmacy
Farmington, Connecticut 06030-2205
United States
Recruiting
UConn Health, Neag Comprehensive Cancer Center
Farmington, Connecticut 06030
United States
Recruiting
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United States
Recruiting
Massachusetts General Hospital (MGH)
Boston, Massachusetts 02114
United States
Recruiting
Brigham & Women's Hospital (BWH)
Boston, Massachusetts 02115
United States
Recruiting
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United States
Recruiting
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
United States
Recruiting
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Recruiting
CUMC Research Pharmacy
New York, New York 10032
United States
Recruiting
Methodist Hospital-Pathology
Houston, Texas 77030
United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Seattle Cancer Care Alliance (Drug Shipment Address)
Seattle, Washington 98109
United States
Recruiting
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting
University of Washington Medical Center
Seattle, Washington 98195
United States
Recruiting
Centre D'Investigation Clinique (CIC)
Paris, 75013
France
Recruiting
Groupe hospitalier Pitie Salpetriere
Paris, 75013
France
Recruiting
Laboratory research biomedical (LRBM)
Paris, 75013
France
Recruiting
Institut Gustave Roussy- Pharmacie-Unite Essais Cliniques
Villejuif, 94805
France
Active, not recruiting
Institut Gustave Roussy
Villejuif, 94805
France
Active, not recruiting
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
Recruiting
The Netherlands Cancer Institute
Amsterdam, 1066 CX
Netherlands
Recruiting
Slotervaart Hospital/Antoni van Leeuwenhoek
Amsterdam, 1066 EC
Netherlands
Recruiting
Erasmus MC Cancer Institute
Rotterdam, 3015 AA
Netherlands
Recruiting
Erasmus MC
Rotterdam, 3015 AE
Netherlands
Recruiting