NCT03530683

Brief Summary

The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers:

  • relapsed or refractory (R/R) lymphoma
  • multiple myeloma
  • newly diagnosed acute myeloid leukemia (AML). This trial will be conducted in the outpatient setting in 2 parts, phase 1a and phase 1b. You may only participate in one part of the study. During phase 1a of this study, we will explore how much maplirpacept (PF-07901801), when used by itself, can be safely used. If you have lymphoma, the study medicine maplirpacept (PF-07901801) will be given by infusion through a vein once a week or once every 2 weeks or every 3 weeks as determined by your doctor. Following your first dose, you will be expected to come back twice more the first week. From week 2, you will have weekly visits for blood tests, questions about your medications, any side effects, or illnesses you may have experienced and your cancer response. After you have completed 21 days (for every week dosing) or 42 days (for every 2- or 3-weeks dosing), your doctor will discuss whether you should stop study treatment or continue. If you continue, you will be expected to come back weekly for blood tests, vital signs, a brief physical exam, asked about any side effects or illnesses you may have experienced and medications you may be taking. The dosing schedule you are assigned to will continue until your disease has worsened, significant side effects occur or other reasons that lead you and your doctor to decide treatment may be stopped. To be eligible for the first part of the study you must be 18 years or older, your disease has worsened after receiving other medicines approved for blood cancer, no other treatment options exist for you, a sample of your tissue for exploratory research which can be taken from tissue already obtained or if necessary, a new sample of your tissue will be taken so your disease may be seen and measured on routine tests/scans. If you have had radiation therapy or received any anticancer medication within 14 days before the planned start of study treatment your doctor will let you know if you are eligible to participate in the study. If you have had major surgery within 30 days before the planned start of study treatment you may not be eligible to participate. The phase 1a part of the study may last up to 51/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason. During phase 1b part of this study, we will explore how much maplirpacept (PF-07901801), when used with other anticancer medicine(s), can be safe and reduce cancer growth. In the phase 1b part of this study, you will receive maplirpacept (PF-07901801) and other anticancer medicine(s). Which medicine combination you will receive depends on the types of cancer under treatment. Your treatment experiences will be examined to determine if maplirpacept (PF-07901801) when given with other anticancer medicine(s), is safe and can reduce cancer growth. To be eligible for the second part of the study you may have newly diagnosed Acute Myelocytic Leukemia with or without a genetic mutation or you have Multiple Myeloma or Diffuse Large B Cell Lymphoma, and your disease has worsened. The Phase 1b part of this study may last as long as you and your study doctor think you may benefit which could be up to approximately 31/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started May 2018

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

62 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

6.2 years

First QC Date

May 8, 2018

Last Update Submit

August 29, 2024

Conditions

Keywords

NeoplasmsLymphomaMyelomaLeukemia

Outcome Measures

Primary Outcomes (10)

  • Phase 1a: Number of adverse events (AE) by severity

    To characterize the safety profile (incidence of AEs)

    Through study completion, up to 18 months

  • Phase 1a: Number of AEs by Frequency

    To characterize the safety profile (incidence of AEs) and

    Through study completion, up to 18 months

  • Phase 1a: Number of participants with Dose-Limiting Toxicities (DLT)

    To characterize the dose limiting toxicities (DLTs) of TTI-622.

    Up to 21-42 days

  • Phase 1b: Number of adverse events (AE) by severity

    To characterize the safety profile (incidence of AEs) of TTI-622 given in combinations or as a single agent.

    Through study completion, up to 30 months

  • Phase 1b: Number of adverse events (AE) by frequency

    To characterize the safety profile (incidence of AEs) of TTI-622 given in combination or as a single agent.

    Through study completion, up to 30 months

  • Phase 1b: Number of participants with disease response

    To evaluate response rate of each combination treatment in the (7) combination cohorts (A1,A2, B1, B2, C1, C2, C3, D1, D2, F1, F2, F3) and for single agent treatment (Cohort E1 and E2). For AML, response = CR. For MM, response = CR+sCR+VGBR+PR. For DLBCL, OR=CR+PR

    Through study completion, up to 30 months

  • Phase 1a: Maximum Tolerated Dose (MTD)

    To characterize the highest dose level for which no more than 1 participant in a dose cohort experienced DLTs.

    Baseline (the start of each sequentially increased treatment dose), up to the 3rd evaluable patient completes DLT observation period of 21 or 42 days.

  • Phase 1b: Recommended dose of TTI-622 in combination with selected anticancer treatments

    To characterize the recommended dose of TTI-622 in combination with selected anticancer treatments in 5 patient populations: * TTI-622 plus azacitidine in newly diagnosed TP53-mutated AML * TTI-622 plus azacitidine and venetoclax in elderly (\>/= 75 years old) or unfit, newly diagnosed TP53-wildtype AML * TTI-622 plus Carfilzomib and dexamethasone in Carfilzomib-refractory, Relapsed/Refractory (R/R) multiple myeloma (MM) after 3 or more prior lines of therapy * TTI-622 plus an anti-CD20 targeting agent (such as ruxience or rituxan) in R/R CD20+ DLBCL after 1 or more prior lines of therapy * TTI-622 plus isatuximab, carfilzomib and dexamethasone in R/R MM after 1-3 prior lines of therapy

    Through study completion, up to 30 months

  • Phase 1b: Recommended dose of TTI-622 as a single agent

    To characterize the recommended dose of TTI-622 as a single agent in patients with R/R MM after 3 or more prior lines of therapy.

    Through study completion, up to 30 months

  • Number of participants with response assessments that show preliminary efficacy

    To evaluate preliminary efficacy of each combination treatment in the selected patient populations and for single-agent treatment in R/R MM

    Through study completion, up to 30 months

Secondary Outcomes (16)

  • Phase 1a: TTI-622 PK parameter AUC0-t

    Through study completion, up to 18 months

  • Phase 1a: TTI-622 PK parameter Cmax

    Through study completion, up to 18 months

  • Phase 1a: Incidence of anti-drug antibodies (ADA)

    Through study completion, up to 18 months

  • Phase 1a: Number of participants with overall response rate (ORR) for participants treated with TTI-622.

    Through study completion, up to 18 months

  • Phase 1a: Number of participants with disease control rate (DCR)

    Through study completion, up to 18 months

  • +11 more secondary outcomes

Study Arms (7)

maplirpacept (PF-07901801) Monotherapy

EXPERIMENTAL

In the phase 1a dose- escalation part for single-agent maplirpacept (PF-07901801), participants with Relapsing or Refractory (R/R) lymphoma will be enrolled in sequential dose cohorts to receive maplirpacept (PF-07901801) QW to characterize safety, tolerability, and PK; to determine the Maximum Tolerated Dose (MTD) or P1b Starting Dose (a dose lower than or equal to the single-agent MTD), and to gain preliminary evidence of antitumor activity. In addition, participants with R/R Lymphoma may also be enrolled in a cohort to receive maplirpacept (PF-07901801) Q2W and a cohort to receive maplirpacept (PF-07901801) Q3W to characterize safety, tolerability, and PK; to determine the MTD; and to gain preliminary evidence of antitumor activity.

Drug: Maplirpacept (PF-07901801)

Cohort A: maplirpacept (PF-07901801) + Azacitidine

EXPERIMENTAL

Cohort A1: participants with newly diagnosed TP53-mutated Acute Myelocytic Leukemia (AML) will be treated with maplirpacept (PF-07901801) QW + azacitidine. Cohort A2: participants with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) QW + azacitidine.

Drug: Maplirpacept (PF-07901801)Drug: Azacitidine

Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax

EXPERIMENTAL

Cohort B1: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax Cohort B2: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax.

Drug: Maplirpacept (PF-07901801)Drug: AzacitidineDrug: Venetoclax

Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent

EXPERIMENTAL

Cohort D1: participants with Relapsing or Recurrent (R/R) CD20+ Diffuse Large B Cell Lymphoma (DLBCL) will be treated with maplirpacept (PF-07901801) QW, then an increased dose Q3W + an anti-CD20 targeting agent. Cohort D2: participants with R/R CD20+ DLBCL will be treated with maplirpacept (PF-07901801) dosed QW for 4 weeks, then an increased dose Q3W + an anti-CD20 targeting agent.

Drug: Maplirpacept (PF-07901801)Drug: Anti-CD20 Targeting agent

Cohort E1 and E2: single agent maplirpacept (PF-07901801)

EXPERIMENTAL

Cohort E1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with single agent maplirpacept (PF-07901801) QW. Cohort E2: participants with R/R MM will be treated with single agent maplirpacept (PF-07901801) increased dose QW.

Drug: Maplirpacept (PF-07901801)

Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone

EXPERIMENTAL

Cohort F1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone. Cohort F2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + isatuximab, carfilzomib and dexamethasone. Cohort F3: participants with R/R MM will be treated with maplirpacept (PF-07901801) increased dose QW + isatuximab, carfilzomib and dexamethasone.

Drug: Maplirpacept (PF-07901801)Drug: CarfilzomibDrug: DexamethasoneDrug: Isatuximab

Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone

EXPERIMENTAL

Cohort C1: participants with Relapsing or Refractory (R/R) Multiple Myeloma (MM) will be treated with maplirpacept (PF-07901801) QW \+ carfilzomib and dexamethasone. Cohort C2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone. Cohort C3: participants with R/R MM will be treated with maplirpacept (PF-07901801) Q2W + carfilzomib and dexamethasone.

Drug: Maplirpacept (PF-07901801)Drug: CarfilzomibDrug: Dexamethasone

Interventions

maplirpacept (PF-07901801) will be administered by intravenous infusion at ranging doses, as determined from sequential dosing cohorts.

Also known as: SIRPα-IgG4 Fc, TTI-622
Cohort A: maplirpacept (PF-07901801) + AzacitidineCohort B: maplirpacept (PF-07901801) + Azacitidine and VenetoclaxCohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and DexamethasoneCohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agentCohort E1 and E2: single agent maplirpacept (PF-07901801)Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasonemaplirpacept (PF-07901801) Monotherapy

intravenous (IV) or subcutaneous (SC) daily for 7 days, repeated every 4 weeks

Also known as: VIDAZA
Cohort A: maplirpacept (PF-07901801) + AzacitidineCohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax

orally daily for each day of each cycle (first 7 doses taken in clinic). The ramp-up and target dose of venetoclax will be adjusted per the package insert in subjects who are taking concomitant moderate or strong CYP3A4 inhibitors or posaconazole

Also known as: VENCLEXTA
Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax

Days 1, 8, and 15 of 28-day cycles; starting dose IV given on Cycle (C) 1 Day (D) 1, and if tolerated, then increased dose via IV given starting on C1D8 and subsequent doses thereafter.

Also known as: KYPROLIS
Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and DexamethasoneCohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone

starting dose via IV on Days 1, 8, 15, and increased dose via IV on 28-day cycles

Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and DexamethasoneCohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone

Days 1,8,15, and 22 of the first 28-day cycle and then on Day 1 of subsequent 21-day cycles. The anti-CD20 targeting agent will be administered for a total of eight doses, and then Cohort F1, F2 and F3: TTI-622 + isatuximab, carfilzomib and dexamethasone Cohort C1, C2 and C3: TTI-622 + Carfilzomib and Dexamethasone will be continued as single-agent therapy.

Also known as: Ruxience or Rituxan
Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent

F1: IV dose C0D1, C0D8, C0D15 and C0D22 (lead in phase);weekly during Cycle 1; Cycle 2 and beyond will be administered on Days 1 and 15 (Q2W). F2 and F3: IV dose C0D1 and C0D8 (lead in phase); C1D1, C1D8, C1D15 and C1D22; Cycle 2 and beyond will be administered on days 1 and 15 (Q2W). Carfilzomib: IV dose on days 1 and 2 of cycle 1; then increased IV dose on days 8, 9, 15, and 16 of cycle 1; cycle 2 and beyond: increased IV dose on days 1, 2, 8, 9, 15, and 16. Dexamethasone IV or PO on days 1, 2, 8, 9, 15, 16, 22, and 23 starting cycle 1.

Also known as: Sarclisa
Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Available fresh or archived tumor tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • Adequate coagulation function.
  • Adequate hepatic function.
  • Adequate hematologic status.
  • Adequate renal function.
  • Recovery from non-hematopoietic toxicities of previous anticancer drugs or radiotherapy or previous surgeries to ≤Grade 1 (or to baseline grade if condition was pre-existing).

You may not qualify if:

  • Known, current central nervous system disease involvement.
  • Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment (within 4 weeks for antibody-based therapies and within 8 weeks for cell-based therapies).
  • Subjects who have undergone radiation therapy within 14 days of study treatment administration.
  • Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or subjects with active graft-vs-host disease, with the exception of Grade 1 skin involvement.
  • Major surgery within 30 days before planned start of study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (62)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Keck Hospital of USC Pasadena

Pasadena, California, 91105, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

HealthONE Presbyterian/St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Christiana Care Hematology Oncology - Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health Services - Christiana Hospital

Newark, Delaware, 19718, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital Cancer Institute

Tampa, Florida, 33606, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Indiana Blood & Marrow Transplantation

Indianapolis, Indiana, 46237, United States

Location

Indiana Blood and Marrow Transplantation-Administrative Offices

Indianapolis, Indiana, 46237, United States

Location

Indiana Blood and Marrow Transplantation-Clinic

Indianapolis, Indiana, 46237, United States

Location

Norton Cancer Institute, St Matthews Campus

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD

Louisville, Kentucky, 40207, United States

Location

Norton Diagnostic Center-Dupont (PET Scans)

Louisville, Kentucky, 40207, United States

Location

Norton Women & Children's Hospital

Louisville, Kentucky, 40207, United States

Location

University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Summit Medical Group Cancer Center

Florham Park, New Jersey, 07932, United States

Location

Memorial Sloan Kettering Cancer Center at Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center at Montvale

Montvale, New Jersey, 07645, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

Location

Memorial Sloan Kettering Cancer Center - David H. Koch Center

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center (Outpatient Center)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Memorial Sloan Kettering Cancer Center at Nassau

Uniondale, New York, 11553, United States

Location

Novant Health Cancer Institute - Research Office

Charlotte, North Carolina, 28204, United States

Location

Novant Health Cancer Institute Hematology - Charlotte

Charlotte, North Carolina, 28204, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Novant Health Cancer Institute - Research Office

Winston-Salem, North Carolina, 27103, United States

Location

Novant Health Cancer Institute Hematology - Forsyth

Winston-Salem, North Carolina, 27103, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Sidney Kimmel Cancer Center, Clinical Trials Organization

Philadelphia, Pennsylvania, 19107, United States

Location

Sidney Kimmel Cancer Center, Research Support Services

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Investigational Drug Services

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University, Investigational Drug Service

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University, Medical Oncology

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Prisma Health, Institute for Translational Oncology Research, Clinical Research Unit

Greenville, South Carolina, 29605, United States

Location

Prisma Health-Upstate Cancer Institute

Greenville, South Carolina, 29605, United States

Location

University of TN Medical Center

Knoxville, Tennessee, 37920, United States

Location

Oncology Consultants P.A.

Houston, Texas, 77030, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaMultiple MyelomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseNeoplasmsNeoplasms, Plasma CellLeukemia

Interventions

AzacitidinevenetoclaxcarfilzomibDexamethasoneRituximabisatuximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLeukemia, MyeloidLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

May 14, 2018

Primary Completion

July 18, 2024

Study Completion

July 18, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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.

Locations