Brief Title
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
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.
Brief 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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Percentage of participants with Dose-limiting toxicities (DLT)
Secondary Outcome
Area under the concentration versus time curve (AUCt)
Condition
Part 1
Intervention
PF-06801591
Study Arms / Comparison Groups
Arm 1 PF-06801591
Description: 0.5 mg/kg IV every 21 days (Part 1)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
147
Start Date
February 10, 2016
Completion Date
November 19, 2020
Primary Completion Date
November 19, 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT02573259
Organization ID
B8011001
Secondary IDs
2016-003314-27
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
May 2021