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NCT02573259

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

Last Updated: 2021-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-10

Study Completion Date

2020-11-19

Brief Summary

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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

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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.

Conditions

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Part 1 MELANOMA SCCHN OVCA SARCOMA OTHER SOLID TUMORS Part 1 and 2 NSCLC UROTHELIAL CARCINOMA

Keywords

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efficacy safety pharmacokinetics pharmacodynamics open label dose response multiple ascending dose immunogenicity recommended phase 2 dose subcutaneous

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 PF-06801591

0.5 mg/kg IV every 21 days (Part 1)

Group Type EXPERIMENTAL

PF-06801591

Intervention Type DRUG

IV every 21 days (Part 1)

Arm 2 PF-06801591

1.0 mg/kg IV every 21 days (Part 1)

Group Type EXPERIMENTAL

PF-06801591

Intervention Type DRUG

IV every 21 days (Part 1)

Arm 3 PF-06801591

3.0 mg/kg IV every 21 days (Part 1)

Group Type EXPERIMENTAL

PF-06801591

Intervention Type DRUG

IV every 21 days (Part 1)

Arm 4 PF-06801591

10 mg/kg IV every 21 days (Part 1)

Group Type EXPERIMENTAL

PF-06801591

Intervention Type DRUG

IV every 21 days (Part 1)

Arm 5 PF-06801591

300 mg SC every 28 days (Part 1 and 2)

Group Type EXPERIMENTAL

PF-06801591

Intervention Type DRUG

300 mg SC every 28 days (Part 1 and 2)

Interventions

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PF-06801591

IV every 21 days (Part 1)

Intervention Type DRUG

PF-06801591

300 mg SC every 28 days (Part 1 and 2)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clinical Research Unit

Los Angeles, California, United States

Site Status

Ronald Reagan Medical Center, Department of Radiological Sciences

Los Angeles, California, United States

Site Status

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, United States

Site Status

UCLA Hematology & Oncology Clinic

Los Angeles, California, United States

Site Status

Santa Monica UCLA Hematology & Oncology Clinic

Santa Monica, California, United States

Site Status

Norton Cancer Institute, Multidisciplinary Clinic

Louisville, Kentucky, United States

Site Status

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States

Site Status

Norton Hospital

Louisville, Kentucky, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Tennessee Oncology, PLLC

Dickson, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Franklin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Gallatin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Hermitage, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Lebanon, Tennessee, United States

Site Status