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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02573259
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Bulgaria, Korea, Republic of, Malaysia, Poland, Russian Federation, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
Study Website: View Trial Website
Additional 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.

Arms & Interventions

Arms

Experimental: Arm 1 PF-06801591

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

Experimental: Arm 2 PF-06801591

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

Experimental: Arm 3 PF-06801591

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

Experimental: Arm 4 PF-06801591

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

Experimental: Arm 5 PF-06801591

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

Interventions

Drug: - PF-06801591

IV every 21 days (Part 1)

Drug: - PF-06801591

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research Unit, Los Angeles, California

Status

Address

Clinical Research Unit

Los Angeles, California, 90024

Los Angeles, California

Status

Address

Ronald Reagan Medical Center, Department of Radiological Sciences

Los Angeles, California, 90095

UCLA Hematology & Oncology Clinic, Los Angeles, California

Status

Address

UCLA Hematology & Oncology Clinic

Los Angeles, California, 90095

Santa Monica, California

Status

Address

Santa Monica UCLA Hematology & Oncology Clinic

Santa Monica, California, 90404

Louisville, Kentucky

Status

Address

Norton Cancer Institute, Multidisciplinary Clinic

Louisville, Kentucky, 40202

Louisville, Kentucky

Status

Address

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, 40202

Norton Hospital, Louisville, Kentucky

Status

Address

Norton Hospital

Louisville, Kentucky, 40202

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada

Status

Address

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169

University of Rochester, Rochester, New York

Status

Address

University of Rochester

Rochester, New York, 14642

Chapel Hill, North Carolina

Status

Address

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600

Tennessee Oncology, PLLC, Dickson, Tennessee

Status

Address

Tennessee Oncology, PLLC

Dickson, Tennessee, 37055

Tennessee Oncology, PLLC, Franklin, Tennessee

Status

Address

Tennessee Oncology, PLLC

Franklin, Tennessee, 37067

Tennessee Oncology, PLLC, Gallatin, Tennessee

Status

Address

Tennessee Oncology, PLLC

Gallatin, Tennessee, 37066

Tennessee Oncology, PLLC, Hermitage, Tennessee

Status

Address

Tennessee Oncology, PLLC

Hermitage, Tennessee, 37076

Tennessee Oncology, PLLC, Lebanon, Tennessee

Status

Address

Tennessee Oncology, PLLC

Lebanon, Tennessee, 37090

Tennessee Oncology, PLLC, Murfreesboro, Tennessee

Status

Address

Tennessee Oncology, PLLC

Murfreesboro, Tennessee, 37129

Tennessee Oncology, PLLC, Nashville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

The Sarah Cannon Research Institute, Nashville, Tennessee

Status

Address

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Tennessee Oncology, PLLC, Nashville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Nashville, Tennessee, 37205

Tennessee Oncology, PLLC, Nashville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Nashville, Tennessee, 37207

Tennessee Oncology, PLLC, Nashville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Nashville, Tennessee, 37211

Tennessee Oncology, PLLC, Shelbyville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Shelbyville, Tennessee, 37160

Tennessee Oncology, PLLC, Smyrna, Tennessee

Status

Address

Tennessee Oncology, PLLC

Smyrna, Tennessee, 37167

International Sites

MHAT Uni Hospital OOD, Panagyurishte, Pazardzhik, Bulgaria

Status

Address

MHAT Uni Hospital OOD

Panagyurishte, Pazardzhik, 4500

Complex Oncology Center - Plovdiv EOOD, Plovdiv, Bulgaria

Status

Address

Complex Oncology Center - Plovdiv EOOD

Plovdiv, , 4000

"MHAT for Women Health - Nadezhda" OOD, Sofia, Bulgaria

Status

Address

"MHAT for Women Health - Nadezhda" OOD

Sofia, , 1330

Varna, Bulgaria

Status

Address

SHATOD "Dr. Marko Antonov Markov - Varna" EOOD

Varna, , 9002

National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

Status

Address

National Cancer Center

Goyang-si, Gyeonggi-do, 10408

Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

Suwon, Gyeonggi-do, Korea, Republic of

Status

Address

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seoul, Korea, Republic of

Status

Address

Division of Medical Oncology, Severance Hospital, Yonsei University Health System

Seoul, , 03722

Seoul, Korea, Republic of

Status

Address

Severance Hospital Yonsei University Health System

Seoul, , 03722

Seoul, Korea, Republic of

Status

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Asan Medical Center, Seoul, Korea, Republic of

Status

Address

Asan Medical Center

Seoul, , 05505

Ulsan University Hospital, Ulsan, Korea, Republic of

Status

Address

Ulsan University Hospital

Ulsan, , 44033

Hospital Sultan Ismail, Johor Bahru, Johor, Malaysia

Status

Address

Hospital Sultan Ismail

Johor Bahru, Johor, 81100

University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur, Malaysia

Status

Address

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100

Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia

Status

Address

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100

Kuching, Sarawak, Malaysia

Status

Address

Clinical Research Centre(Crc), Hospital Umum Sarawak

Kuching, Sarawak, 93586

Gdynia, Poland

Status

Address

Szpitale Pomorskie Sp. z.o.o., Oddzial Onkologii i Radioterapii

Gdynia, , 81-519

Grudziadz, Poland

Status

Address

Regionalny Szpital Specjalistyczny im. dr. Wl. Bieganskiego w Grudziadzu

Grudziadz, , 86-300

Krakow, Poland

Status

Address

Centrum Badan Klinicznych JCI Life Science Park

Krakow, , 30-348

Ostroleka, Poland

Status

Address

Mazowiecki Szpital Specjalistyczny im. Dr. Jozefa Psarskiego w Ostrolece, Osrodek Onkologiczny

Ostroleka, , 07-410

Otwock, Poland

Status

Address

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina

Otwock, , 05-400

Warszawa, Poland

Status

Address

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

Warszawa, , 02-781

Sbhi "Lrcod", Vsevolozhsky District, Leningrad Region, Russian Federation

Status

Address

Sbhi "Lrcod"

Vsevolozhsky District, Leningrad Region, 188663

Pesochny Village, Saint-petersburg, Russian Federation

Status

Address

SBHI ¨Saint-Petersburg clinical scientific practical center of specialized types of

Pesochny Village, Saint-petersburg, 197758

SBHI "ChRCCO and NM", Chelyabinsk, Russian Federation

Status

Address

SBHI "ChRCCO and NM"

Chelyabinsk, , 454087

Moscow, Russian Federation

Status

Address

MROI n.a. P.A. Gertsen, filiation of FSBI "NMRC of radiology" MoH Russia

Moscow, , 125284

Omsk, Russian Federation

Status

Address

BHI of Omsk Region "Clinical Oncology Dispensary"

Omsk, , 644013

Saint-Petersburg, Russian Federation

Status

Address

Joint Stock Company Current medical technologies

Saint-Petersburg, , 190013

Saint-Petersburg, Russian Federation

Status

Address

Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨

Saint-Petersburg, , 195271

Saint-Petersburg, Russian Federation

Status

Address

SPb SBHI "City Clinical Oncology Dispensary"

Saint-Petersburg, , 197022

Saint-Petersburg, Russian Federation

Status

Address

SPb SBHI "City Clinical Oncology Dispensary"

Saint-Petersburg, , 198255

St. Petersburg, Russian Federation

Status

Address

Joint-Stock Company Current medical technologies

St. Petersburg, , 190121

Yaroslavl, Russian Federation

Status

Address

SBHI YaR ¨Regional clinical oncology hospital¨

Yaroslavl, , 150054

Dnipro, Ukraine

Status

Address

Communal Non-profit Institution "City Clinical Hospital #4" of Dnipro City Council, Department of

Dnipro, , 49102

Ivano-Frankivsk, Ukraine

Status

Address

Communal non-Commercial Enterprise "Prykarpatski Clinical Oncological Center of Ivano-

Ivano-Frankivsk, , 79018

Kharkiv, Ukraine

Status

Address

Grigoriev Radiological Institute of the National Academy of Medical Sciences of Ukraine,

Kharkiv, , 61024

Kharkiv, Ukraine

Status

Address

Communal Non-profit Institution of Kharkiv Regional Council "Regional Clinical Specialized Health

Kharkiv, , 61166

Kyiv, Ukraine

Status

Address

"Specialized Clinic "Prognosis Optima" LLC

Kyiv, , 03126

Sumy, Ukraine

Status

Address

Communal noncommercial enterprise Sumy regional Rada Sumy regional clinical oncologic dispensary,

Sumy, , 40030

Uzhhorod, Ukraine

Status

Address

Communal Non-profit Institution "Central City Clinical Hospital" of Uzhhorod City Council,

Uzhhorod, , 88000

Vinnytsia, Ukraine

Status

Address

Vinnytsia Regional Clinical Oncological Hospital

Vinnytsia, , 21029

Zaporizhzhya, Ukraine

Status

Address

Communal Institution ¨Zaporizhzhya Regional Clinical Oncological Dispensary¨

Zaporizhzhya, , 69040

Stay Informed & Connected