A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
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.
Checked against the public recordLast updated Dec 13, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: PF-06801591; Drug: PF-06801591
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria (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. Exclusion Criteria (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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clinical Research UnitLos Angeles, California
- Ronald Reagan Medical Center, Department of Radiological SciencesLos Angeles, California
- Ronald Reagan UCLA Medical Center, Drug Information CenterLos Angeles, California
- UCLA Hematology & Oncology ClinicLos Angeles, California
- Santa Monica UCLA Hematology & Oncology ClinicSanta Monica, California
- Norton Cancer Institute, Multidisciplinary ClinicLouisville, Kentucky
- Norton Cancer Institute, Norton Healthcare PavilionLouisville, Kentucky
- Norton HospitalLouisville, Kentucky
- Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
- University of RochesterRochester, New York
- UNC Hospitals, The University of North Carolina at Chapel HillChapel Hill, North Carolina
- Tennessee Oncology, PLLCDickson, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2021. Always confirm current availability with the study team.