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AzTrials

Part 1Phase 1NCT02573259

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

A Phase 1 study testing PF-06801591 in people with Part 1 and MELANOMA, run by Pfizer at 67 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Part 1, MELANOMA, SCCHN
What is being tested?
PF-06801591
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
67 sitesin 7 countries
Study dates
10 Feb 2016to 19 Nov 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

67 sites in 7 countries.

67 sites in 7 countries

United States24 sites

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7600

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Clinical Research Unit

    Los Angeles, California, 90024

  • Ronald Reagan Medical Center, Department of Radiological Sciences

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095

  • UCLA Hematology & Oncology Clinic

    Los Angeles, California, 90095

  • Norton Cancer Institute, Multidisciplinary Clinic

    Louisville, Kentucky, 40202

  • Norton Cancer Institute, Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • University of Rochester

    Rochester, New York, 14642

  • Santa Monica UCLA Hematology & Oncology Clinic

    Santa Monica, California, 90404

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

Other trials in United States

Russia11 sites

  • SBHI "ChRCCO and NM"

    Chelyabinsk, 454087

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

    Moscow, 125284

  • BHI of Omsk Region "Clinical Oncology Dispensary"

    Omsk, 644013

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

    Pesochny Village, Sankt-Peterburg, 197758

  • Joint Stock Company Current medical technologies

    Saint Petersburg, 190013

  • Joint-Stock Company Current medical technologies

    Saint Petersburg, 190121

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

    Saint Petersburg, 195271

  • SPb SBHI "City Clinical Oncology Dispensary"

    Saint Petersburg, 197022

  • SPb SBHI "City Clinical Oncology Dispensary"

    Saint Petersburg, 198255

  • Sbhi "Lrcod"

    Vsevolozhsky District, Leningradskaya Oblast', 188663

  • SBHI YaR ¨Regional clinical oncology hospital¨

    Yaroslavl, 150054

Other trials in Russia

South Korea9 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

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

    Seoul, 03722

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

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

    Suwon, Gyeonggi-do, 16247

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Ukraine9 sites

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

    Dnipro, 49102

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

    Ivano-Frankivsk, 79018

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

    Kharkiv, 61024

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

    Kharkiv, 61166

  • "Specialized Clinic "Prognosis Optima" LLC

    Kyiv, 03126

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

    Sumy, 40030

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

    Uzhhorod, 88000

  • Vinnytsia Regional Clinical Oncological Hospital

    Vinnytsia, 21029

  • Communal Institution ¨Zaporizhzhya Regional Clinical Oncological Dispensary¨

    Zaporizhzhya, 69040

Other trials in Ukraine

Poland6 sites

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

    Gdynia, 81-519

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

    Grudziądz, 86-300

  • Centrum Badan Klinicznych JCI Life Science Park

    Krakow, 30-348

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

    Ostrołęka, 07-410

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina

    Otwock, 05-400

  • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Bulgaria4 sites

  • MHAT Uni Hospital OOD

    Panagyurishte, Pazardzhik, 4500

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4000

  • "MHAT for Women Health - Nadezhda" OOD

    Sofia, 1330

  • SHATOD "Dr. Marko Antonov Markov - Varna" EOOD

    Varna, 9002

Other trials in Bulgaria

Malaysia4 sites

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Clinical Research Centre(Crc), Hospital Umum Sarawak

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

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.

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.

Read the 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.

Being tested
PF-06801591
Keywords
efficacy, safety, pharmacokinetics, pharmacodynamics, open label, dose response, multiple ascending dose, immunogenicity, recommended phase 2 dose, subcutaneous
Medical subject headings
Melanoma, Sarcoma, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06801591Drug

    IV every 21 days (Part 1)

  • PF-06801591Drug

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

Study groups in NCT02573259
Study groupRoleWhat they receive
Arm 1 PF-06801591Experimental0.5 mg/kg IV every 21 days (Part 1)
Receives: Drug: PF-06801591
Arm 2 PF-06801591Experimental1.0 mg/kg IV every 21 days (Part 1)
Receives: Drug: PF-06801591
Arm 3 PF-06801591Experimental3.0 mg/kg IV every 21 days (Part 1)
Receives: Drug: PF-06801591
Arm 4 PF-06801591Experimental10 mg/kg IV every 21 days (Part 1)
Receives: Drug: PF-06801591
Arm 5 PF-06801591Experimental300 mg SC every 28 days (Part 1 and 2)
Receives: Drug: PF-06801591

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1

    DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting >5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count <10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting >7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

    Measured: Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)

  2. Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2

    AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

    Measured: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)

  3. Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2

    Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

    Measured: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)

  4. Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2

    Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase [GGT], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio [INR] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

    Measured: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)

  5. Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2

    ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

  6. Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2

    ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

Secondary outcomes (19)

  1. Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1

    Cmax was the maximum concentration after dose administration observed directly from the data.

    Measured: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

  2. AUClast of PF-06801591 in Part 1.

    Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1

    Measured: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1

  3. Clearance (CL) of PF-06801591 - Part 1

    CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.

    Measured: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

  4. Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1

    Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.

    Measured: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1

  5. Accumulation Ratio (Rac) of PF-06801591 - Part 1

    Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.

    Measured: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1

  6. Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1

    t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.

    Measured: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1

  7. Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2

    Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.

    Measured: Baseline up to end of treatment (maximum of 851 days)

  8. Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2

    Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative.

    Measured: Baseline up to end of treatment (maximum of 851 days)

  9. Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1

    PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as [(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)]*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.

    Measured: Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)

  10. Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1

    Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.

    Measured: Baseline up to end of treatment in Part 1 (maximum of 1606 days)

  11. Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1

    Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases >=30%.

    Measured: Baseline up to end of treatment in Part 1 (maximum of 1606 days)

  12. Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2

    PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.

    Measured: Baseline up to end of treatment (maximum of 1606 days)

  13. Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2

    DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis < 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.

    Measured: Baseline up to end of treatment (maximum of 1606 days)

  14. Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2

    DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.

    Measured: Baseline up to end of treatment (maximum of 1606 days)

  15. Time to Response (TTR) Based on RECIST Version 1.1 - Part 2

    TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis < 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

  16. Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2

    TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

  17. Median Time to Death - Part 2

    Median time to death was analyzed by the Kaplan-Meier approach for each tumor type.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

  18. Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2

    Probability of survival was calculated from the product-limit method.

    Measured: Baseline up to end of treatment in Part 2 (maximum of 851 days)

  19. Trough PF-06801591 Concentrations (Ctrough) - Part 2

    Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.

    Measured: Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study start10 Feb 2016
  3. Primary completion19 Nov 2020
  4. Study completion19 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573259
Sponsor's protocol ID
B8011001
Other IDs
2016-003314-27, 2016
Status last verified
Oct 2021
First submitted
6 Oct 2015
Last updated
13 Dec 2021
Data monitoring committee
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Sako C, Duan C, Maresca K, Kent S, Schmidt TG, Aerts HJWL, Parikh RB, Simon GR, Jordan P. Real-World and Clinical Trial Validation of a Deep Learning Radiomic Biomarker for PD-(L)1 Immune Checkpoint Inhibitor Response in Advanced Non-Small Cell Lung Cancer. JCO Clin Cancer Inform. 2024 Dec;8:e2400133. doi: 10.1200/CCI.24.00133. Epub 2024 Dec 13.

    PubMed 39671539

  • Hu-Lieskovan S, Braiteh F, Grilley-Olson JE, Wang X, Forgie A, Bonato V, Jacobs IA, Chou J, Johnson ML. Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration. Target Oncol. 2021 Nov;16(6):773-787. doi: 10.1007/s11523-021-00833-2. Epub 2021 Oct 25.

    PubMed 34694529

  • Johnson ML, Braiteh F, Grilley-Olson JE, Chou J, Davda J, Forgie A, Li R, Jacobs I, Kazazi F, Hu-Lieskovan S. Assessment of Subcutaneous vs Intravenous Administration of Anti-PD-1 Antibody PF-06801591 in Patients With Advanced Solid Tumors: A Phase 1 Dose-Escalation Trial. JAMA Oncol. 2019 Jul 1;5(7):999-1007. doi: 10.1001/jamaoncol.2019.0836.

    PubMed 31145415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06801591 in people with Part 1 and MELANOMA, run by Pfizer at 67 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Russia, South Korea, Ukraine, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 (time frame: Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573259, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.

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