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

• ClinicalTrials.gov Identifier: NCT02573259
• Recruitment Status: Completed
• First Posted: October 9, 2015
• Results First Posted: December 13, 2021
• Last Update Posted: December 13, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Part 1; MELANOMA; SCCHN; OVCA; SARCOMA; OTHER SOLID TUMORS; Part 1 and 2; NSCLC; UROTHELIAL CARCINOMA	Drug: PF-06801591	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 147 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: February 10, 2016
• Actual Primary Completion Date: November 19, 2020
• Actual Study Completion Date: November 19, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1 PF-06801591; 0.5 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 2 PF-06801591; 1.0 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 3 PF-06801591; 3.0 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 4 PF-06801591; 10 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 5 PF-06801591; 300 mg SC every 28 days (Part 1 and 2)	Drug: PF-06801591; 300 mg SC every 28 days (Part 1 and 2)

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   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.
2. Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 [ Time Frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) ]
   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.
3. Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 [ Time Frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) ]
   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.
4. Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 [ Time Frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) ]
   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.
5. Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
   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.
6. Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
   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.

Secondary Outcome Measures :

1. Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 [ Time Frame: 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 ]
   Cmax was the maximum concentration after dose administration observed directly from the data.
2. AUClast of PF-06801591 in Part 1. [ Time Frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 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
3. Clearance (CL) of PF-06801591 - Part 1 [ Time Frame: 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 ]
   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.
4. Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 [ Time Frame: 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 ]
   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.
5. Accumulation Ratio (Rac) of PF-06801591 - Part 1 [ Time Frame: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in 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.
6. Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1 [ Time Frame: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in 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.
7. Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 [ Time Frame: Baseline up to end of treatment (maximum of 851 days) ]
   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.
8. Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 [ Time Frame: Baseline up to end of treatment (maximum of 851 days) ]
   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.
9. Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 [ Time Frame: 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) ]
   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.
10. Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 [ Time Frame: Baseline up to end of treatment in Part 1 (maximum of 1606 days) ]
    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.
11. Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 [ Time Frame: Baseline up to end of treatment in Part 1 (maximum of 1606 days) ]
    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%.
12. Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 [ Time Frame: Baseline up to end of treatment (maximum of 1606 days) ]
    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.
13. Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 [ Time Frame: Baseline up to end of treatment (maximum of 1606 days) ]
    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.
14. Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 [ Time Frame: Baseline up to end of treatment (maximum of 1606 days) ]
    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.
15. Time to Response (TTR) Based on RECIST Version 1.1 - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
    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.
16. Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
    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.
17. Median Time to Death - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
    Median time to death was analyzed by the Kaplan-Meier approach for each tumor type.
18. Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 [ Time Frame: Baseline up to end of treatment in Part 2 (maximum of 851 days) ]
    Probability of survival was calculated from the product-limit method.
19. Trough PF-06801591 Concentrations (Ctrough) - Part 2 [ Time Frame: Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2 ]
    Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Clinical Research Unit

Los Angeles, California, United States, 90024

Ronald Reagan Medical Center, Department of Radiological Sciences

Los Angeles, California, United States, 90095

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, United States, 90095

UCLA Hematology & Oncology Clinic

Los Angeles, California, United States, 90095

Santa Monica UCLA Hematology & Oncology Clinic

Santa Monica, California, United States, 90404

United States, Kentucky

Norton Cancer Institute, Multidisciplinary Clinic

Louisville, Kentucky, United States, 40202

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States, 40202

Norton Hospital

Louisville, Kentucky, United States, 40202

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

United States, New York

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7600

United States, Tennessee

Tennessee Oncology, PLLC

Dickson, Tennessee, United States, 37055

Tennessee Oncology, PLLC

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC

Gallatin, Tennessee, United States, 37066

Tennessee Oncology, PLLC

Hermitage, Tennessee, United States, 37076

Tennessee Oncology, PLLC

Lebanon, Tennessee, United States, 37090

Tennessee Oncology, PLLC

Murfreesboro, Tennessee, United States, 37129

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

The Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37205

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37207

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37211

Tennessee Oncology, PLLC

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology, PLLC

Smyrna, Tennessee, United States, 37167

Bulgaria

MHAT Uni Hospital OOD

Panagyurishte, Pazardzhik, Bulgaria, 4500

Complex Oncology Center - Plovdiv EOOD

Plovdiv, Bulgaria, 4000

"MHAT for Women Health - Nadezhda" OOD

Sofia, Bulgaria, 1330

SHATOD "Dr. Marko Antonov Markov - Varna" EOOD

Varna, Bulgaria, 9002

Korea, Republic of

National Cancer Center

Goyang-si, Gyeonggi-do, Korea, Republic of, 10408

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

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

Suwon, Gyeonggi-do, Korea, Republic of, 16247

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 21565

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

Seoul, Korea, Republic of, 03722

Severance Hospital Yonsei University Health System

Seoul, Korea, Republic of, 03722

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Ulsan University Hospital

Ulsan, Korea, Republic of, 44033

Malaysia

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia, 81100

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia, 59100

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia, 25100

Clinical Research Centre(Crc), Hospital Umum Sarawak

Kuching, Sarawak, Malaysia, 93586

Poland

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

Gdynia, Poland, 81-519

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

Grudziadz, Poland, 86-300

Centrum Badan Klinicznych JCI Life Science Park

Krakow, Poland, 30-348

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

Ostroleka, Poland, 07-410

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina

Otwock, Poland, 05-400

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

Warszawa, Poland, 02-781

Russian Federation

Sbhi "Lrcod"

Vsevolozhsky District, Leningrad Region, Russian Federation, 188663

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

Pesochny Village, Saint-petersburg, Russian Federation, 197758

SBHI "ChRCCO and NM"

Chelyabinsk, Russian Federation, 454087

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

Moscow, Russian Federation, 125284

BHI of Omsk Region "Clinical Oncology Dispensary"

Omsk, Russian Federation, 644013

Joint Stock Company Current medical technologies

Saint-Petersburg, Russian Federation, 190013

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

Saint-Petersburg, Russian Federation, 195271

SPb SBHI "City Clinical Oncology Dispensary"

Saint-Petersburg, Russian Federation, 197022

SPb SBHI "City Clinical Oncology Dispensary"

Saint-Petersburg, Russian Federation, 198255

Joint-Stock Company Current medical technologies

St. Petersburg, Russian Federation, 190121

SBHI YaR ¨Regional clinical oncology hospital¨

Yaroslavl, Russian Federation, 150054

Ukraine

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

Dnipro, Ukraine, 49102

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

Ivano-Frankivsk, Ukraine, 79018

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

Kharkiv, Ukraine, 61024

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

Kharkiv, Ukraine, 61166

"Specialized Clinic "Prognosis Optima" LLC

Kyiv, Ukraine, 03126

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

Sumy, Ukraine, 40030

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

Uzhhorod, Ukraine, 88000

Vinnytsia Regional Clinical Oncological Hospital

Vinnytsia, Ukraine, 21029

Communal Institution ¨Zaporizhzhya Regional Clinical Oncological Dispensary¨

Zaporizhzhya, Ukraine, 69040

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] August 7, 2018

Statistical Analysis Plan  [PDF] August 24, 2020

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02573259
• Other Study ID Numbers: B8011001; 2016-003314-27 ( EudraCT Number )
• First Posted: October 9, 2015
• Results First Posted: December 13, 2021
• Last Update Posted: December 13, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Carcinoma; Melanoma; Sarcoma; Head and Neck Neoplasms; Carcinoma, Transitional Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Neoplasms, Connective and Soft Tissue