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PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies

Last updated on December 10, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Malignancies, Non-small-cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age ≥18 years (≥ 20 years in Japan)

- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow function, renal and liver functions Phase 1b

- Histological or Cytological diagnosis of advanced solid tumor with clinical evidence
of response to anti-PD-1 or PD-L1 agent

- Participant must have received at least 1 prior line of therapy for recurrent or
metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to
standard therapy approved for the specific tumor type Phase 2

- Participants must have a documented diagnosis of stage III where participants are not
candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC

- EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not
permitted

- Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS]
≥1%) or unknown are eligible

- Up to 1 line of prior therapy in advanced disease settings allowed

- Participant should not have received prior treatment with anti PD-1/PD-L1 drugs

- At least one measurable lesion as defined by RECIST version 1.1

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Participants with known symptomatic brain metastases requiring steroids

- Baseline (defined as the timepoint prior to the first dose of drug, i.e screening or
Cycle 1 Day 1 (C1D1))12-lead electrocardiogram (ECG) that demonstrates clinically
relevant abnormalities that may affect participant safety or interpretation of study
results

- Hypertension that cannot be controlled by medications (eg, >150/90 mmHg) despite
optimal medical therapy

- Known or suspected hypersensitivity to active ingredient or excipients of the study
drug.

- History of Grade ?3 immune mediated AE (including AST/ ALT elevations that where
considered drug related and cytokine release syndrome [CRS]) that was considered
related to prior immune modulatory therapy (eg, immune checkpoint inhibitors,
co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b
only)

NCT04181788
Pfizer
Not yet recruiting
PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies

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Advanced Malignancies, Non-small-cell Lung Cancer
NCT04181788
All Genders
Descriptive Information
Brief Title  ICMJE PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Official Title  ICMJE A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies
Brief Summary

This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies.

This study consists of 2 parts:

Phase 1b part in patients with advanced malignancies in Japan and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancies
  • Non-small-cell Lung Cancer
Intervention  ICMJE Drug: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
Study Arms  ICMJE
  • Experimental: Arm A1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B1 (Phase 1b)
    Intervention: Drug: PF-06801591
  • Experimental: Arm A2 (Phase 2)
    Intervention: Drug: PF-06801591
  • Experimental: Arm B2 (Phase 2)
    Intervention: Drug: PF-06801591
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2022
Estimated Primary Completion DateMay 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ?18 years (? 20 years in Japan)
  • Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow function, renal and liver functions Phase 1b
  • Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent
  • Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2
  • Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
  • EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted
  • Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS] ?1%) or unknown are eligible
  • Up to 1 line of prior therapy in advanced disease settings allowed
  • Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
  • At least one measurable lesion as defined by RECIST version 1.1

Exclusion Criteria:

  • Participants with known symptomatic brain metastases requiring steroids
  • Baseline (defined as the timepoint prior to the first dose of drug, i.e screening or Cycle 1 Day 1 (C1D1))12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Hypertension that cannot be controlled by medications (eg, >150/90 mmHg) despite optimal medical therapy
  • Known or suspected hypersensitivity to active ingredient or excipients of the study drug.
  • History of Grade ?3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome [CRS]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04181788
Other Study ID Numbers  ICMJE B8011007
2019-003818-14 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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