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Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.

Primary Purpose

Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-07257876
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring PD-L1 (Programmed death-ligand 1), CD47 (cluster of differentiation 47), immunotherapy, macrophage checkpoint inhibitor, advanced solid tumor, metastatic solid tumor, Ovarian Cancer, Lung Cancer, Non-small cell lung cancer, Head and Neck cancer, SCCHN, NSCLC, solid tumor, advanced cancer, metastatic cancer, Squamous cell carcinoma of the head and neck, Squamous cell head and neck cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histological/cytological diagnosis of selected advanced or metastatic tumor
  • Prior treatment with PD-1 (Programmed cell death 1) or PD-L1 (programmed death-ligand 1) in NSCLC and SCCHN or platinum-based therapy in Ovarian cancer
  • Confirmed radiographic progression of disease
  • PD-L1 IHC positivity ≥1%
  • Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
  • Eastern Cooperative Oncology Group performance status 0-1
  • Adequate hematologic, renal and liver functions
  • Resolved acute effects of any prior therapy
  • Participants in Part 1 must be able to provide archival tumor tissue collected within the prior 6 months or consent to undergo a fresh biopsy during screening. Participants enrolled to the MTD (Maximum Tolerated Dose) cohort in Part 1 must consent to mandatory paired pre-treatment and on-treatment biopsies. Participants in Part 2 must consent to a pre-treatment biopsy and a subset of patients must consent to a paired on-study biopsy as well until the Sponsor deems an adequate number have been received.

Exclusion Criteria:

  • Participants with known brain metastasis larger than 4 cm or that is symptomatic. New brain metastases detected at screening. Participants with previously diagnosed brain metastases are eligible if they have completed treatment and recovered from acute effects prior to study entry.
  • Abnormal neurological assessment by investigator
  • Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation therapy within 4 weeks prior to planned first dose
  • Last systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas)
  • Active bleeding disorder in the past 6 months prior to first dose
  • History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia), evidence of active pneumonitis on screening chest CT(computer tomography) scan
  • Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed
  • Treatment with chronic systemic corticosteroids or other immunosuppressive medications
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
  • Active, uncontrolled bacterial, fungal, or viral infection, Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) infection
  • Active COVID-19/SARS-CoV2
  • Pregnant or breastfeeding female participant
  • Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
  • Significant cardiac or pulmonary conditions or events within previous 6 months

Sites / Locations

  • Mayo Clinic Hospital
  • Mayo Clinic
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Hoag Hospital Irvine
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
  • Keck Hospital of USC
  • Keck School of Medicine of USC
  • LAC+USC Medical Center
  • USC/Norris Comprehensive Cancer Center
  • Hoag Memorial Hospital Presbyterian
  • Keck Hospital of USC Pasadena
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
  • Mayo Clinic Jacksonville
  • Mayo Clinic Rochester
  • Siteman Cancer Center - West County
  • Siteman Cancer Center-North County
  • Barnes-Jewish Hospital
  • Washington University School of Medicine
  • Washington University
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - St Peters
  • Hackensack University Medical Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Duke Cancer Institute
  • UPMC Hillman Cancer Center - Camp Hill
  • UPMC Hillman Cancer Center - Carlisle
  • UPMC Hillman Cancer Center Erie
  • UPMC Pinnacle - Community Osteopathic / Medical Sciences Pavilion (MSP)
  • UPMC Pinnacle - Ortenzio Cancer Center (OCC)
  • Magee-Womens Hospital of UPMC
  • UPMC Hillman Cancer Center
  • UPMC Shadyside Hospital
  • UPMC Memorial
  • Rhode Island Hospital
  • The Miriam Hospital
  • Virginia Cancer Specialists
  • Seattle Cancer Care Alliance
  • Hospital Universitari Vall d'Hebron
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation (Part 1)

Dose Expansion (Part 2) - Cohort 1 (NSCLC)

Dose Expansion (Part 2) - Cohort 2 (SCCHN)

Arm Description

Participants will receive PF-07257876 at escalating dose levels.

Participants with non-small cell lung cancer (NSCLC) will receive PF-07257876 at the recommended dose from Part 1.

Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07257876 at the recommended dose from Part 1.

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1)
DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Number of participants with adverse events (AEs)
AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.
Number of participants with clinically significant laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Objective response rate (ORR) in the Expansion cohorts (Part 2)
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Single dose Pharmacokinetics (PK) parameter: Maximal concentration (Cmax) in Part 1
Maximum observed plasma concentration of PF-07257876 (Cmax)
Single dose PK parameter: Time to maximal plasma concentration (Tmax) in Part 1
Time to maximal observed plasma concentration of PF-07257876 (Tmax)
Single dose PK parameter: Area under the Curve (AUClast) in Part 1
Area under the concentration-time curve from time zero to the last quantifiable time point prior to the next dose.
Multiple dose PK parameter: Maximal concentration (Cmax, ss) in Part 1
Maximum observed steady state plasma concentration of PF-07257876 (Cmax, ss)
Multiple dose PK parameter: Time to maximal plasma concentration (Tmax, ss) in Part 1
Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss).
Multiple dose PK parameter: Area under the Curve (AUCtau, ss) in Part 1
Area Under the curve within one dose interval at steady state (AUCtau,ss)
Immunogenicity of PF-07257876
Incidence, titers, and duration (if data permit) of antidrug antibodies (ADA) and neutralizing antibodies against PF-07257876
Intratumor T cell levels
Immune biomarker levels in archival biopsies and/or de novo and on-treatment tumor biopsies.
Intratumor PD-L1 expression
PD-L1 expression levels in pretreatment tumor biopsies
ORR in Dose Escalation (Part 1)
Tumor response assessment based on RECIST 1.1
Duration of response (DOR)
DOR as assessed using RECIST 1.1
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Time to progression (TTP)
TTP as assessed using RECIST 1.1
Lowest concentration (Ctrough) reached before the next dose is administered in Part 2
PK assessment for PF-07257876
Overall Survival (OS) in the Expansion Cohorts (Part 2)
Proportion of patients alive

Full Information

First Posted
April 9, 2021
Last Updated
September 8, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04881045
Brief Title
Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.
Official Title
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07257876 IN PATIENTS WITH ADVANCED OR METASTATIC TUMORS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
October 27, 2023 (Anticipated)
Study Completion Date
October 27, 2023 (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
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer
Keywords
PD-L1 (Programmed death-ligand 1), CD47 (cluster of differentiation 47), immunotherapy, macrophage checkpoint inhibitor, advanced solid tumor, metastatic solid tumor, Ovarian Cancer, Lung Cancer, Non-small cell lung cancer, Head and Neck cancer, SCCHN, NSCLC, solid tumor, advanced cancer, metastatic cancer, Squamous cell carcinoma of the head and neck, Squamous cell head and neck cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation (Part 1)
Arm Type
Experimental
Arm Description
Participants will receive PF-07257876 at escalating dose levels.
Arm Title
Dose Expansion (Part 2) - Cohort 1 (NSCLC)
Arm Type
Experimental
Arm Description
Participants with non-small cell lung cancer (NSCLC) will receive PF-07257876 at the recommended dose from Part 1.
Arm Title
Dose Expansion (Part 2) - Cohort 2 (SCCHN)
Arm Type
Experimental
Arm Description
Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07257876 at the recommended dose from Part 1.
Intervention Type
Biological
Intervention Name(s)
PF-07257876
Intervention Description
CD47-PDL-1 bispecific antibody
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1)
Description
DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Time Frame
Baseline through end of Cycle 1 (each cycle is 28 days)
Title
Number of participants with adverse events (AEs)
Description
AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.
Time Frame
Baseline through up to 2 years
Title
Number of participants with clinically significant laboratory abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Time Frame
Baseline through up to 2 years
Title
Objective response rate (ORR) in the Expansion cohorts (Part 2)
Description
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
Baseline through up to 2 years or until disease progression
Secondary Outcome Measure Information:
Title
Single dose Pharmacokinetics (PK) parameter: Maximal concentration (Cmax) in Part 1
Description
Maximum observed plasma concentration of PF-07257876 (Cmax)
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Single dose PK parameter: Time to maximal plasma concentration (Tmax) in Part 1
Description
Time to maximal observed plasma concentration of PF-07257876 (Tmax)
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Single dose PK parameter: Area under the Curve (AUClast) in Part 1
Description
Area under the concentration-time curve from time zero to the last quantifiable time point prior to the next dose.
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Multiple dose PK parameter: Maximal concentration (Cmax, ss) in Part 1
Description
Maximum observed steady state plasma concentration of PF-07257876 (Cmax, ss)
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Multiple dose PK parameter: Time to maximal plasma concentration (Tmax, ss) in Part 1
Description
Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss).
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Multiple dose PK parameter: Area under the Curve (AUCtau, ss) in Part 1
Description
Area Under the curve within one dose interval at steady state (AUCtau,ss)
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Immunogenicity of PF-07257876
Description
Incidence, titers, and duration (if data permit) of antidrug antibodies (ADA) and neutralizing antibodies against PF-07257876
Time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Title
Intratumor T cell levels
Description
Immune biomarker levels in archival biopsies and/or de novo and on-treatment tumor biopsies.
Time Frame
Baseline through Cycle 2 Day 15 (each cycle is 28 days)
Title
Intratumor PD-L1 expression
Description
PD-L1 expression levels in pretreatment tumor biopsies
Time Frame
Baseline through Cycle 2 Day 15 (each cycle is 28 days)
Title
ORR in Dose Escalation (Part 1)
Description
Tumor response assessment based on RECIST 1.1
Time Frame
Baseline through up to 2 years or until disease progression
Title
Duration of response (DOR)
Description
DOR as assessed using RECIST 1.1
Time Frame
Baseline through up to 2 years or until disease progression
Title
Progression free survival (PFS)
Description
PFS as assessed using RECIST 1.1
Time Frame
Baseline through up to 2 years or until disease progression
Title
Time to progression (TTP)
Description
TTP as assessed using RECIST 1.1
Time Frame
Baseline through up to 2 years or until disease progression
Title
Lowest concentration (Ctrough) reached before the next dose is administered in Part 2
Description
PK assessment for PF-07257876
Time Frame
Pre-dose on Day 1 at Cycles 1, 2, 3, 4, 5 and every third cycle thereafter (each cycle is 28 days) and End of Treatment visit, up to 2 years
Title
Overall Survival (OS) in the Expansion Cohorts (Part 2)
Description
Proportion of patients alive
Time Frame
Baseline through up to 2 years or until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological/cytological diagnosis of selected advanced or metastatic tumor Prior treatment with PD-1 (Programmed cell death 1) or PD-L1 (programmed death-ligand 1) in NSCLC and SCCHN or platinum-based therapy in Ovarian cancer Confirmed radiographic progression of disease PD-L1 IHC positivity ≥1% Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated Eastern Cooperative Oncology Group performance status 0-1 Adequate hematologic, renal and liver functions Resolved acute effects of any prior therapy Participants in Part 1 must be able to provide archival tumor tissue collected within the prior 6 months or consent to undergo a fresh biopsy during screening. Participants enrolled to the MTD (Maximum Tolerated Dose) cohort in Part 1 must consent to mandatory paired pre-treatment and on-treatment biopsies. Participants in Part 2 must consent to a pre-treatment biopsy and a subset of patients must consent to a paired on-study biopsy as well until the Sponsor deems an adequate number have been received. Exclusion Criteria: Participants with known brain metastasis larger than 4 cm or that is symptomatic. New brain metastases detected at screening. Participants with previously diagnosed brain metastases are eligible if they have completed treatment and recovered from acute effects prior to study entry. Abnormal neurological assessment by investigator Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ Major surgery or radiation therapy within 4 weeks prior to planned first dose Last systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas) Active bleeding disorder in the past 6 months prior to first dose History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy) History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia), evidence of active pneumonitis on screening chest CT(computer tomography) scan Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed Treatment with chronic systemic corticosteroids or other immunosuppressive medications Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose Active, uncontrolled bacterial, fungal, or viral infection, Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) infection Active COVID-19/SARS-CoV2 Pregnant or breastfeeding female participant Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant Significant cardiac or pulmonary conditions or events within previous 6 months
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
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Hoag Hospital Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Keck Hospital of USC Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center-North County
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center - St Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UPMC Hillman Cancer Center - Camp Hill
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
UPMC Hillman Cancer Center - Carlisle
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
UPMC Pinnacle - Community Osteopathic / Medical Sciences Pavilion (MSP)
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
UPMC Pinnacle - Ortenzio Cancer Center (OCC)
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17050
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Memorial
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17408
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain

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=C4401001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.

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