Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.

Official Title

A Phase 1, Open-label, Dose Escalation And Expansion Study Of Pf-06801591 In Patients With Locally Advanced Or Metastatic Melanoma, Squamous Cell Head And Neck Cancer, Ovarian Cancer, Sarcoma, Non-small Cell Lung Cancer, Urothelial Carcinoma Or Other Solid Tumors.

Details

Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose, safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or subcutaneous (SC) in previously treated adult patients with locally advanced or metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma, sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid tumors.

The first part of the study, Part 1 dose escalation, was designed to assess the safety and tolerability of increasing dose levels of IV or SC administered PF-06801591 to establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval (mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1 enrollment has completed, enrollment will only be allowed for Part 2.

Keywords

Part 1 MELANOMA SCCHN OVCA SARCOMA OTHER SOLID TUMORS Part 1 and 2 NSCLC UROTHELIAL CARCINOMA efficacy safety pharmacokinetics pharmacodynamics open label dose response multiple ascending dose immunogenicity recommended phase 2 dose subcutaneous Carcinoma Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms Carcinoma, Transitional Cell PF-06801591

Eligibility

You can join if…

Open to people ages 18 years and up

(Part 2 Only):

  • Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable.
  • No prior treatment with anti-PD-1 or anti-PD-L1 therapy.
  • NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy.
  • NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies.
  • Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy. If urothelial cancer patients are treatment naïve and eligible for platinum-containing systemic therapy but are refusing platinum chemotherapy, they must also be documented to have previous PD-L1 high status.
  • Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample.
  • At least one measurable lesion as defined by RECIST version 1.1.
  • Adequate renal, liver, thyroid and bone marrow function.
  • Performance status 0 or 1.
  • Patient is capable of receiving study treatment for at least 8 weeks.

You CAN'T join if...

(Part 2 Only)

  • Active brain or leptomeningeal metastases.
  • Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant.
  • Patients with a condition requiring systemic treatment with either corticosteroids(>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded.
  • History of Grade ≥3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy.
  • Active hepatitis B or C, HIV/AIDS.
  • Other potentially metastatic malignancy within past 5 years.

Locations

  • Ronald Reagan Medical Center, Department of Radiological Sciences in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center in progress, not accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology & Oncology Clinic in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Santa Monica UCLA Hematology & Oncology Clinic in progress, not accepting new patients
    Santa Monica California 90404 United States
  • Research Administration Office: Clinical Research Unit in progress, not accepting new patients
    Los Angeles California 90024 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT02573259
Phase
Phase 1
Study Type
Interventional
Last Updated