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Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06940434
PF-06801591
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.

Part 2:

  • Arm A SCCHN:

    • Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
    • PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).

  • Arm B RCC (clear cell):

    • 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
  • Adequate bone marrow, kidney and liver function.
  • Performance status of 0 or 1.

Exclusion Criteria:

  • Participant disease status is suitable for local therapy administered with curative intent.
  • Hypertension that cannot be controlled by medications.
  • Active or prior autoimmune disease
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness

Sites / Locations

  • Scottsdale Healthcare Hospitals DBA HonorHealthRecruiting
  • Virginia G. Piper Cancer PharmacyRecruiting
  • Ronald Reagan UCLA Medical Center
  • UCLA Hematology Oncology
  • UCLA Hematology/Oncology
  • Greenebaum Comprehensive Cancer CenterRecruiting
  • University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
  • Siteman Cancer Center - West County
  • Siteman Cancer Center - North County
  • Barnes-Jewish Hospital
  • Washington University School of Medicine Siteman Cancer Center
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - North County
  • Siteman Cancer Center - St. Peters
  • Monter Cancer CenterRecruiting
  • R.J. Zuckerberg Cancer CenterRecruiting
  • Duke Univ. Medical Center/Duke Cancer Center
  • Investigational Chemotherapy Service
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • NEXT Oncology
  • University of Washington Medical Center
  • Liverpool HospitalRecruiting
  • Southern Medical Day Care CentreRecruiting
  • Asan Medical CenterRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Onkologicky ustav sv. Alzbety, s.r.o.Recruiting
  • Univerzitna nemocnica BratislavaRecruiting
  • Narodny ustav srdcovych a cievnych chorob, a.s.Recruiting
  • KARDIO, s.r.o.
  • POKO Poprad, s.r.o., Ambulancia klinickej onkologie
  • MR Poprad s.r.o.
  • Nemocnica Poprad a.s.
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Dose Finding Anti-PD-1 Combination 1

Dose Expansion Arm A

Dose Expansion Arm B

Dose Expansion, Arm C

Arm Description

Single Agent Dose Escalation

Part 1B PF-06940434 plus anti-PD-1

PF-06940434 with anti-PD-1 in SCCHN

PF-06940434 with anti-PD-1 in RCC

PF-06940434 with anti-PD-1 (both Q3W)

Outcomes

Primary Outcome Measures

Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Number of Participants With Adverse Events (AEs) According to Severity
Number of Participants With Adverse Events (AEs) According to Seriousness
Number of Participants With Adverse Events (AEs) by Relationship
Progression-Free Survival (PFS) for Dose Expansion
The period from study entry until disease progression, death or date of last contact.
Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
Duration of Response (DR) for Dose Expansion

Secondary Outcome Measures

PF-06940434 after multiple doses PK parameters (Cmax).
Maximum observed plasma concentration of PF-06940434.
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Volume of Distribution (Vd)
Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.
Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.
Titers of neutralizing antibodies (NAb) against PF-06940434.
PK parameters of PF-06940434 and PF-06801591 (Cmax).
Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
Maximum observed plasma concentration of PF-06940434.
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Number of participants with increased T-cells after PF-06940434 treatment.
Progression-Free Survival (PFS) for Dose Expansion
The period from study entry until disease progression, death or date of last contact.
Duration of Response (DR)
Number of Participants With Objective Response for Dose Expansion portion
Disease Control Rate (DCR)
DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.
Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.
Overall Survival
The period from study entry until death or date of last contact (24 months)

Full Information

First Posted
October 30, 2019
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04152018
Brief Title
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Official Title
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Lung Squamous Cell Carcinoma, Pancreatic Cancer, Bile Duct Cancer, Endometrial Cancer, Melanoma Cancer, Urothelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Single Agent Dose Escalation
Arm Title
Dose Finding Anti-PD-1 Combination 1
Arm Type
Experimental
Arm Description
Part 1B PF-06940434 plus anti-PD-1
Arm Title
Dose Expansion Arm A
Arm Type
Experimental
Arm Description
PF-06940434 with anti-PD-1 in SCCHN
Arm Title
Dose Expansion Arm B
Arm Type
Experimental
Arm Description
PF-06940434 with anti-PD-1 in RCC
Arm Title
Dose Expansion, Arm C
Arm Type
Experimental
Arm Description
PF-06940434 with anti-PD-1 (both Q3W)
Intervention Type
Drug
Intervention Name(s)
PF-06940434
Intervention Description
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
Intervention Type
Drug
Intervention Name(s)
PF-06801591
Other Intervention Name(s)
Anti-PD-1
Intervention Description
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Primary Outcome Measure Information:
Title
Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Time Frame
Baseline up to 28 Days (Cycle 1)
Title
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time Frame
Baseline up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) According to Severity
Time Frame
Baseline up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) According to Seriousness
Time Frame
Baseline up to up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) by Relationship
Time Frame
Baseline up to approximately 24 months
Title
Progression-Free Survival (PFS) for Dose Expansion
Description
The period from study entry until disease progression, death or date of last contact.
Time Frame
Baseline up to 24 Months
Title
Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
Time Frame
Baseline up to 24 months
Title
Duration of Response (DR) for Dose Expansion
Time Frame
Baseline up to 24 Months
Secondary Outcome Measure Information:
Title
PF-06940434 after multiple doses PK parameters (Cmax).
Description
Maximum observed plasma concentration of PF-06940434.
Time Frame
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Description
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Time Frame
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
Systemic Clearance (CL)
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
Volume of Distribution (Vd)
Time Frame
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.
Time Frame
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.
Description
Titers of neutralizing antibodies (NAb) against PF-06940434.
Time Frame
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Title
PK parameters of PF-06940434 and PF-06801591 (Cmax).
Description
Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).
Time Frame
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Title
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Description
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Time Frame
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Title
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
Description
Maximum observed plasma concentration of PF-06940434.
Time Frame
Cycle 4 Day 1 (each cycle is 28 days)
Title
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Description
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Time Frame
Cycle 4 Day 1 (each cycle is 28 days)
Title
Number of participants with increased T-cells after PF-06940434 treatment.
Time Frame
Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Title
Progression-Free Survival (PFS) for Dose Expansion
Description
The period from study entry until disease progression, death or date of last contact.
Time Frame
Baseline to measured progression (up to approximately 24 months)
Title
Duration of Response (DR)
Time Frame
Baseline up to approximately 24 Months
Title
Number of Participants With Objective Response for Dose Expansion portion
Time Frame
Baseline up to 24 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.
Time Frame
Every 8 weeks from the time of enrollment up to 2 years
Title
Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion
Time Frame
Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days)
Title
Plasma Decay Half-Life (t1/2)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]
Title
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion
Description
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.
Time Frame
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Title
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.
Description
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.
Time Frame
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Title
Overall Survival
Description
The period from study entry until death or date of last contact (24 months)
Time Frame
From baseline to up to 2 years after last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer. Part 2: Arm A SCCHN: Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx. PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease). Arm B RCC (clear cell): 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment Adequate bone marrow, kidney and liver function. Performance status of 0 or 1. Exclusion Criteria: Participant disease status is suitable for local therapy administered with curative intent. Hypertension that cannot be controlled by medications. Active or prior autoimmune disease Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare Hospitals DBA HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia G. Piper Cancer Pharmacy
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCLA Hematology Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCLA Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Siteman Cancer Center - North County
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Siteman Cancer Center - North County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Siteman Cancer Center - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
R.J. Zuckerberg Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Univ. Medical Center/Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Investigational Chemotherapy Service
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Onkologicky ustav sv. Alzbety, s.r.o.
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
82101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Narodny ustav srdcovych a cievnych chorob, a.s.
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
KARDIO, s.r.o.
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
POKO Poprad, s.r.o., Ambulancia klinickej onkologie
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
MR Poprad s.r.o.
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Nemocnica Poprad a.s.
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3891001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

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